11 08 11 Newsletter

VOLUME 7, ISSUE 35 | NOVEMBER 8, 2011
week in review
4 9
The Top Ten Best New Spine Technologies for 2011 Despite ever growing
hurdles to innovation and entrepreneurism in spine, ten solid new technologies earned the top award for innovation and clinical effectiveness for 2011. This year, diagnostics and biologics were the most innovative and popular categories. And the winners are
Spine Fusion Reimbursement: Science or Politics? A recent study reviewed medi-
13 17
cal payer policies for fusion. The study found discrepancies in the evidence used to develop the policies and, generally lacked transparency. Some payer policies are based on guidelines that are not even publicly available for review. Read what the spine experts told OTW about the study.
Orthopaedic Crossfire Tackles Metal on Metal A Current Concepts in
Joint Replacement debate between Joshua J. Jacobs, M.D. and Thomas P. Schmalzried, M.D. Hear what each party has to say about metal on metal.
Reporters Notebook
Committee of 12 with a bulls-eye on healthcare? New hires at K2Mout of the way, FDAWhat Peter Indelicato, president of AOSSM, is excited about, and ohhear what happens when some Viscogliosis go hunting. (Hint: no one was shot in a small bone.)
Zimmers 3rd Quarter - Steady Growth, Waiting for Patients ................................................ Orthofix Beats Market and Expectations in 3Q11 ...................................................................... NuVasive 3Q11: Noisy and Upward ...................................................................... Wright Medical 3Q: Ailing, Taking Medicine ..................................................................... Smith & Nephew Revenue Grows 10% in 3Q11 ...................................................................... New Options for Damaged Ankles ...................................................................... Whistleblower Costs DFine $2.39 Million for Kickbacks ...................................................................... Spineology Launches Own Fusion Device ...................................................................... JBJS: Timing of Lumbar Surgery
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breaking news
For all news that is ortho, read on.

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2
Orthopedic Power Rankings
Robin Youngs Entirely Subjective Ordering of Public Orthopedic Companies
This Week: Is this market melting up or down? We think that demand for all equitiesorthopedics included is likely heading south for the winter. The earliest that buyers emerge with any conviction, we think, will be on election year eve, just before the New Hampshire primaries in January.
Rank
Last Week
2
Company
TTM Op Margin
27.75%
30-Day Price Change

-1.42%
Comment
ZMH adding $550 milion to war chest. Time to buy growth? We think so. Also the least expensive company in ortho. InFuse attacked from the podium at NASS, but got plenty of support from rank and file surgeons on the floor. Up one spot. Buyers bidding SYK up which puts the company in the middle of the pack in terms of value. Down a couple of spots. Great earnings report last week. Profits up a very impressive 33%. Buyers will take notice, for sure. Big jump for OFIX. 18% sales growth in September quarter led by strong orthopedic sales. But valuation now down to 10th most attractive in ortho. 6.8% sales growth in Q3 but a 6% profit decline due to higher overhead. Saving grace, that high dividend and the coming Synthes purchase. Flat sales but earnings beat Wall Streets consensus. More products being made in Mexicomeans more profit gains in future quarters. Reported only 3% orthopedic sales growth in Q3 and profits were a disappointing 15.6%. Down a couple spots this week. 34% jump in extremity sales plus 19% rise in hip sales and 7% increase in knee sales puts EXAC back on the rankings. IART hit a serious air pocket last week. Investors worried about weak gross profit margin and lower operating profits as well.
Zimmer
Medtronic
28.63
6.57
Stryker
25.23
1.95
Orthofix
14.72
1.64
Kensey Nash Johnson & Johnson Conmed Smith & Nephew Exactech
34.24
0.66
26.33
2.84
9.65
10.83
22.8
1.1
NR
7.69
5.78
10
Integra
15.38
-15.37
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Top Performers Last 30 Days
Company 1 2 3 4 5 6 7 8 9 10 Bacterin Intl Holdings RTI Biologics Inc TiGenix Conmed CryoLife MAKO Surgical Synthes Medtronic Exactech Johnson & Johnson Symbol BONE RTIX TIG.BR CNMD CRY MAKO SYST.VX MDT EXAC JNJ Price $2.88 $4.51 $1.10 $26.41 $4.69 $37.44 $168.12 $34.38 $15.55 $64.12 Mkt Cap $114 $249 $101 $737 $132 $1,552 $19,969 $36,305 $204 175,712 30-Day Chg 44.72% 31.49% 21.92% 10.83% 7.32% 7.19% 6.72% 6.57% 5.78% 2.84% 1 2 3 4 5 6 7 8 9 10 Company
Robin Youngs Orthopedic Universe

Worst Performers Last 30 Days
Symbol TSON IART WMGI NUVA ATEC TRNX ARTC ZMH KNSY SNN Price $1.66 $29.56 $15.27 $15.19 $2.05 $19.31 $28.27 $51.30 $25.88 $44.26 Mkt Cap $47 $793 $601 $642 $183 $756 $778 $9,192 $224 $7,907 30-Day Chg -45.93% -15.37% -13.39% -10.96% -8.07% -1.98% -1.94% -1.42% 0.66% 1.10% TranS1 Integra LifeSciences Wright Medical NuVasive Alphatec Holdings Tornier N.V. ArthroCare Zimmer Holdings Kensey Nash Smith & Nephew
Lowest Price / Earnings Ratio (TTM)

Company 1 2 3 4 5 Medtronic Zimmer Holdings Integra LifeSciences Smith & Nephew Johnson & Johnson Symbol MDT ZMH IART SNN JNJ Price $34.38 $51.30 $29.56 $44.26 $64.12 Mkt Cap $36,305 $9,192 $793 $7,907 $175,712 P/E 10.45 10.89 12.21 12.86 13.09 1 2 3 4 5
Highest Price / Earnings Ratio (TTM)

Company Wright Medical RTI Biologics Inc NuVasive Synthes ArthroCare Symbol WMGI RTIX NUVA SYST.VX ARTC Price $15.27 $4.51 $15.19 $168.12 $28.27 Mkt Cap $601 $249 $642 $19,969 $778 P/E 32.49 28.19 22.67 21.28 19.77
Lowest P/E to Growth Ratio (Earnings Estimates)

Company 1 2 3 4 5 Orthofix RTI Biologics Inc Zimmer Holdings Stryker Exactech Symbol OFIX RTIX ZMH SYK EXAC Price $34.17 $4.51 $51.30 $48.56 $15.55 Mkt Cap $629 $249 $9,192 $18,583 $204 PEG 0.77 1.00 1.17 1.26 1.41 1 2 3 4 5
Highest P/E to Growth Ratio (Earnings Estimates)

Company ArthroCare Kensey Nash Wright Medical NuVasive Johnson & Johnson Symbol ARTC KNSY WMGI NUVA JNJ Price $28.27 $25.88 $15.27 $15.19 $64.12 Mkt Cap $778 $224 $601 $642 175,712 PEG 3.29 3.06 2.71 2.59 2.23
Lowest Price to Sales Ratio (TTM)

Company 1 2 3 4 5 Symmetry Medical Conmed Alphatec Holdings Exactech Integra LifeSciences Symbol SMA CNMD ATEC EXAC IART Price $8.24 $26.41 $2.05 $15.55 $29.56 Mkt Cap $299 $737 $183 $204 $793 PSR 0.83 1.03 1.07 1.07 1.08 1 2 3 4 5
Highest Price to Sales Ratio (TTM)

Company TiGenix MAKO Surgical Synthes Bacterin Intl Holdings Tornier N.V. Symbol TIG.BR MAKO SYST.VX BONE TRNX Price $1.10 $37.44 $168.12 $2.88 $19.31 Mkt Cap $101 $1,552 $19,969 $114 $756 PSR 161.93 35.03 5.42 4.97 3.33
PSR: Aggregate current market capitalization divided by aggregate sales and the calculation excluded the companies for which sales figures are not available.
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By Robin Young
The Top Ten Best New Spine Technologies for 2011

5. Is it cost effective? 6. I would use it. Our panel of surgeons scores every submission on a scale of 1 to 5 (5 being the highest score) for each of the above criteria. We and our panel of surgeons were impressed that inventorsdespite ever growing hurdles to innovation and entrepreneurism in spinestill managed to create a solid group of new products to submit for the 2011 Orthopedics This Week Spine Technology Awards.
he winners of the 2011 Orthopedics This Week Best New Technology Award for Spine are: Advanced Biologics, LLC, Aesculap, Inc., AlloSource, CoAlign Innovations, Inc., Ellipse Technologies, Inc., NeuroLogica Corporation, NLT SPINE, Nocimed, LLC, The Society for Minimally Invasive Spine Surgery and Thompson MIS. This annual award rewards inventors, engineering teams, surgeons and their companies whove created the most innovative, enduring and practical products in 2011 to treat back pain. To win the Orthopedics This Week Best
New Technology for spine care, a new technology must meet the following criteria: 1. Be creative and innovative. 2. Have long-term significance to the problem of treating the diseases of the spine. Does this technology have staying power? 3. Solve a clinical problem. To what extent does this technology solve a current clinical problem or problem that is inadequately solved today? 4. Does it have the potential to improve standard of care?
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Advanced Biologics, LLC Aesculap, Inc. AlloSource Aspen Medical Products, Inc. Cardinal Spine, LLC CareFusion CoAlign Innovations, Inc. Ellipse Technologies, Inc. Exactech, Inc. joimax, Inc. K2M, Inc. Life Spine, Inc. MEDICREA Minimus Spine Inc.
We offer our thanks and deep appreciation to the engineering teams, surgeon inventors and the following companies for submitting their best ideas this year:
NLT SPINE Nocimed, LLC NuVasive, Inc. OsteoMed LLC SI-BONE, Inc. SIGNUS Medical, LLC Society for MIS Surgery SpineWorks
NeuroLogica Corporation
Ranier Technology Ltd. Thompson MIS
Our panel of surgeon judges was: Dr. Neel Anand: Director of Orthopaedic Spine Surgery at the Cedars-Sinai Spine Center Dr. Scott Boden: Professor of Orthopedic Surgery and Director of the Emory Orthopaedics & Spine Center Dr. Isador Lieberman: Medical Director of the Scoliosis and Spine Tumor Center and Orthopedic Surgeon with Texas Back Institute Dr. Ken Pettine: Co-Founder of Rocky Mountain Associates in Orthopedic Medicine and Co-Inventor of the Maverick Artificial Disc. So, without further delay, here are the ten best new spine technologies for 2011 arranged in alphabetical order: AccuLIF Expandable Interbody Fusion Cage CoAlign Innovations, Inc. AccuLIF is a crescent shaped, expandable Interbody Fusion (IBF) cage which is implanted by the surgeon using a transforaminal approach. The cages design incorporates a dual piston/cylinder shape and may be hydraulically expanded using sterile saline after being implanted by the surgeon. CoAlign created an articulating insertion handle for the surgeon to use to ensure optimal implant positioning between vertebral bodies. As the AccuLIF cage expands, a spring activated, automatic, locking mechanism locks the implant at 1mm increments. Finally, the engineers built into the implant a link between the two locking cylinders which ensures that the device will lock evenly. CoAlign is located at 150 North Hill Drive, Suite 1, Brisbane, California 94005. Phone: 760-683-4215. AlloStem Stem Cell Bone Growth Substitute AlloSource AlloStem is a living cellular allograft implant which is a unique combination of partially demineralized allograft bone and adipose derived mesenchymal stem cells. The material is designed to offer surgeons an alternative to iliac crest harvest or other autograft materials for the surgical repair of boney defects. AlloSources proprietary processing system permits an intact partially demineralized allograft strip or cube to be implanted as a bridge between vertebrae. AlloStem is an osteoconductive scaffold, osteoinductive natural growth factors and living cells to support new bone formation. AlloSource is located at 6278 South Troy Circle, Centennial, Colorado. Phone: 720-382-2756
From left to right: Murali Kadaba Chief Scientific Officer, John Ashley VP of R&D, and John Barrett CEO
AccuLIF Expandable Interbody Fusion Cage
From left to right: David White Senior Product Manager,Kevin Cmunt - Senior Vice President, Tom Cycyota - President and CEO, and Judy Lawten Vice President, Marketing
AlloStem Stem Cell Bone Growth Substitute
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From left to right: Greg Johnson, Alison Aviles, David Webster, Matt Dickman, CEO Dr. Eric Bailey, and Benjamin Powell
BodyTom NeuroLogica Corporation The BodyTom is a battery powered, portable CT scannerradiolucent spine table includedwith impressive imaging power. The BodyTom transforms any operating room into an intraoperative spine imaging suite. BodyTom is a full body, 32 slice CT with an impressive 85cm gantry and a 60cm field of view. It is capable of imaging the entire spine, from C1 to S5 in one pass, providing the surgeon with high quality 3D images of both bone and soft tissue. Finally, the BodyTom easily interfaces with surgical navigation systems that accept DICOM images. Intraoperative images can be uploaded to surgical navigation via PACS connection, direct network cable link, wireless transmission or digital media transfer device (CD/USB). NeuroLogica is located at 14 Electronics Avenue, Danvers, Massachusetts 01923. Phone: 978-564-8500. BoneBac Press Thompson MIS The BoneBac press recycles bone collected from the surgical site during spine fusion surgery. BoneBac press improves upon the customary bone harvesting methods in several ways. Unlike traditional bone harvesting, BoneBac press keeps the harvested bone at the surgical site. Using a vacuum hose, the BoneBac pulls harvested bone into the press. Once collected, the surgeon can separate blood and fluid from the bone using the easy press system. BoneBac press is reusable and sterilizable. The system was designed to also work with allograft bone extenders. Finally, using the BoneBac press spine surgeons can significantly reduce if not eliminate secondary graft site morbidity. BoneBac Presss inventor is Mick Perez-Cruet M.D., MS. He can be reached at perezcruet@yahoo.com. Thompson MIS can be reached at info@thompsonmis.com or 888932-6949 Hydrolift Vertebral Body Replacement System Aesculap, Inc. The Hydrolift Vertebral Body Replacement System uses hydrostatic pressure to expand and maintain distraction of the disc space. Other expandable cages use a screw mechanism or ratchet style mechanical approach to achieve distraction. Because of this, other cages require a very high cross sectional area and therefore excess bone removal while performing the corpectomy. Since Hydrolift uses hydrostatic pressure and an external hydraulic pump, surgeons can preserve more of the patients host bone. Finally, the Hydrolift incorporates a failsafe mechanism in the hydraulic pump which limits the amount of pressure available to minimize or prevent endplate damage. Aesculap can be reached at 3773 Corporate Parkway, Center Valley, Pennsylvania 18034. Phone: 610-984-9242.
BodyTom
BoneBac Press
From left to right: Robin YoungPublisher OTW and Mick Perez-Cruet M.D., MS on behalf of Thomson MIS
Ti 6AI-4V ELI centerless ground rod
restored my life.
From left to right: Larry RubensVice President - Aesculap Implant Systems Sales, Chuck DiNardoPresident - CEO, Jeffrey ColeDirector Spine Marketing, Gordon Young-Product Manager Spine, and Ira Benson-Vice President Spine Marketing.
When you need the highest grade centerless ground rod and wire products for your orthopaedic application, call the world leader.
Hydrolift Vertebral Body Replacement System
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MAGEC External Remote Controller (ERC)
Magnetic Expansion Control (MAGEC) Ellipse Technologies, Inc. The Magnetic Expansion system uses a cylindrical, radially-poled internal magnet to noninvasively lengthen or shorten an implanted rod. Early onset scoliosis patients have spinal deformity which is diagnoses before the age of ten. Surgically fusing the spines of these patients at such a young age creates an enormous risk of permanently undersizing the thoracic cavity and therefore reducing the amount of space for developing lungs and organs. Repeated surgeries to adjust rod length raises new problems. The MAGEC system solves this problem. The magnet inside MAGECs rods drives a lead screw which moves the two ends of the rod. The surgeon controls the magnet using an External Remote Controller (ERC). In a lengthening procedure the patient lies awake on an examining table. The ERC is placed on the patients back and within a few minutes the MAGEC rod has been non-invasively lengthened. If the patient feels discomfort, the rod can also be shortened until the discomfort disappears. Ellipse Technologies may be reached at 13900 Alton Parkway, Suite 123, Irvine, California 92618. Phone: 949-837-3600. Nociscan Virtual Discogram Nocimed, LLC Nociscan is a non-invasive test which distinguishes painful from non-painful lumbar discs and thereby better localizes the source of chronic, severe discogenic low back pain. Nociscan is a custom, proprietary software application that works in concert with commercially available Magnetic Resonance Spectroscopy (MRS) pulse sequence installed on standard, high field MRI systems. Nociscans proprietary protocols create a non-invasive exam to acquire chemical information from lumbar intervertebral discs. The data is processed to measure disc pain biomarkers in the discs that have been correlated to pain. Nociscan then uses a diagnostic algorithm based on measured biomarkers to generate a Nociscore which is useful for distinguishing painful from non-painful discs. Nocimed is located at the Plug and Play Tech Center, 370 Convention Way, Redwood City, California 94063. Phone: 650-241-1740. OsteoAMP Structural Advanced Biologics, LLC OsteoAMP is an allograft derived interbody spacer and granules which, according to the company, has more growth factors than DBMs and, in animal models, grows bone at a higher rate than stem cells or synthetics. The key to OsteoAMP is the process Advanced Biologics uses to create the material. Collagen subfibrils are swelled to increase growth factor binding sites. The growth factors contained within bone marrow are solubilized and the soluble growth factors then bind to the swollen collagen subfibrils. When the subfibrils are reduced back to their original size and configuration, they have a higher amount of BMP-2 than, for example, 100% DBM products. The process, in other words, significantly increases the growth factor content of the implant. Advanced Biologics is located at 555 Corporate Drive, Suite 260, Ladera Ranch, California 92694. Phone: 800-272-0267.
MAGEC Dual Rods
Nociscan Virtual Discogram
James Peacock-CEO, Nocimed, LLC
From left to right: Scott Cadotte-VP Sales & Marketing, Amit Govil - President, and Jason Mattiello - Stategic Sales & Marketing Manager
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From left to right: Robin Young-Publisher OTW and Didier Toubia-Chief Executive Officer
PROW FUSION Intervertebral Body Fusion Device NLT SPINE The PROW device is a tool for distracting, preparing and filling the intervertebral space less invasively (7mm width conduit) and thereby magnify the benefits of minimally invasive TLIF procedures (shorter length of stay, shorter time to ambulation and lower overall cost). The key to the PROW is its unique conduit which is really a kind of cannula, but with so much more engineering and capabilities that it is more accurately described as a conduit. The articulating conduit gives the surgeon the ability to insert and use large implants and surgical tools through a small incision. Because the tool articulates, it enters the body straight but then sequentially deflects at an accurate inflection point so as to form a predefined shape on the treatment site. NLT SPINE may be reached at 6 Yoni Netanyahu Street, Or Yehuda, Israel 60376. Phone: 972-3-634-4514. SMISS Prospective Data Registry Society for Minimally Invasive Spine Surgery While not a specific implant, the role of data in improving patient selection, surgical plans and overall treatment protocols is as importantpotentially even more sothan hardware or technique. The Society of MIS Surgery (SMISS) (as well as NASS and AAOS) has committed to developing a registry program to collect data from surgeries, organize it and then provide it back to the surgical community. SMISS is conducting a multi-center prospective study of minimally invasive spinal surgery data for the treatment of degenerative lumbar spondylolisthesis, degenerative disc disease, spinal stenosis, disc herniation and degenerative scoliosis. This registry is the first large-scale, multi-center study of spinal fusion and endoscopic surgical method outcomes with minimally invasive spine surgery. For more information, please contact Kevin Liang Ph.D. at kliang@milestonecro.com.
PROW FUSION Intervertebral Body Fusion Device
SMISS Prospective Data Registry
From left to right: Robin YoungPublisher OTW and Choll Kim M.D., Ph. D.
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By Walter Eisner
Spine Fusion Reimbursement: Science or Politics?

here has been a fourfold rise in spine fusion treatments over the last 20 years. The higher expenditures have spurred an increase in clinical guidelines and payer policies to determine appropriate treatments and payments. But are the clinical guidelines consistent with each other? Are payer policies developed by consultants like Milliman operating under the same rigorous transparent and consistent research requirements used to develop clinical guidelines? Are biased payer policies superseding physician determination? A recent study published in Spine (SPINE Volume 36, Number 21S, pp S144S163) sought to answer these questions. Comparing Quality of Evidence
EFFECT
S OF S AND Clinic PAYER POLICIE for theal Guidelin S es and Treatm Joseph Payer ent of Marce S. Cheng, M lo Gru D Po Chron enberg , MS,* Mic ha , MD, ic Low licies on F Lesl el J. Lee, M ie E. Pi lcher, D, Eric Mas Back P usion MPH, sicotte BA,|| an , ain d And MD, Bryan rea C. Ashm
SPINE
Photo Creation by RRY Publications/Morguefile
GUIDE
LINE
Volum e 36, Nu 201 1, Lipp mber 21S, pp incott William S144S163 s&W ilkins
Study Desig n. Syste Objec tiv m apprais e. The purp atic review. Skelly al of ge os , PhD, an, MD, neral an e of this re on the MPH|| treatm view d fusio ent is to n the qu provid Metho ality an of chronic no specic cli e a cr ds ni d evid policies itical Guideli . An electr ence ba nradicular lo cal practice . onic lit w back gu ne Clea se of fu Summ erature pain an idelines for He ringhou sion gu ary of sear d com alth Te ideline se and spondy Backgr pare s and chnolo the Inter ch of PubM clinica losis as ound select ed, l pr gy As nationa sociated fusion, payer Data. sessm nonrad actice guid l Netw the Nationa ha with lo ent wa The tre elines l icular w back associa s risen fourfo s perfo ork of Agen on asse atmen low ba as we pain wi ld in th ted he cie t of rmed ck pain ssmen ll as re alth ca e past and pa lumba t to iden s , inclu levant two de th lumbar ar re costs publicl yer po r ding th and treatmen tify technol throde ca , there y avail lic of the ose on t of ch sis, or ogy as able pr is an in des. Given th was als medica ies inuenc use of ronic sessm ivate an crease e signi in o perfo l nece lumba on med ents. A cant in clini d publ ssity of g patient tre r fusio studies rmed. ical lit Google cal gu ic paye atmen n, a treatm A hand cit erature of the ideline t op r polic search ent, su Apprais ed for supp search physici will fre ies re for ch as lu tions. Assessm s or al of an in effectiv quently Guideli t of the reco was used to lated to fusio the ca ent used to en superse mbar fusions mm nes n identif pr presen ess and costs re of their , based de the y spec quality ovide a stand Research an endations m patient ting wi of the deter ic ade. A of deve ar . Conc d th low value modi erns re mination lopmen dized assessm Evaluation in guid back pa surgical tre of surg ed gardin atmen eli instrum ical tre t of th in has ent m and pa t of sp g the e evid atmen ent wa placed apprais nes and selec yer inal di ence ba ethod for ev al enorm ted he or med policies have ts to our pa sorder aluating s se an ou alt Results of the eviden tients. ical ne a majo the As both s scrutiny on s ce base h policies. Th d recommen . Thre cessity, r impa nonrad e syste the clinica PubM dations is was ct on th suppor of lum icular ed sear l gu matic combi e perc low ba bar fu ch yie reviews ting the reco ned wi eived eff idelines sions ck pain sampl lding 94 for the mmen th e of , a revie ectiven of gene dations treatm ve gu ess, w of th taken ral gu From the ent of ideline citations we . ideline is topi fro *Depa re inclu chroni s with Cente c was s from rtmen Clearin m 182 cit c r, ded. A reco underta ations a gh Unive Medical Ce t of Neuro conven ken. identi mmendatio rsi logica nte Techno ouse and th ience l ns Neuro ty of Wash r North, ed by e Inter logy As Nashvil Surgery, Vand surgery, ington nationa the Na on fusion sessm US prof Direc was l Ne ent sear tio tor of Toronto West Medical le, TN; De erbilt Unive essiona Ortho partm ches. Tw twork of Ag nal Guideli Surgery, Cente ern Ho l socie three ent of rsity Medica pa ne encies were ties, (n o guid l Ortho Aires, edics Carlo Canberra spital, Un r, Seattle, Euro elines eurosu fo pe W Argenti ive s Ho and th were de r Health rger na; an E. Ottolengh spital, Ca rsity of ToronA; Divisiondics, e Euro pean-based Acknow d ||Sp velope guideli y and pain m pean of genera ledgm ectrum i, Italian Honberra, Austr to, Toronto, d by Cooper nes (B ent da l guid ali Resea The ma elgium anagement), te: May ation rch, Incspital of Buen a; Institu ON; elines for di in Scien , Unite and 7, 2011 te ., Taco device(s nuscript su were agnosis ma, W os Aires, Bu of d King . Acce bmitte consist ce an )/drug , but treatm enos A. ptance d does (s). dom, d ent wi Profes incons ent. date: Jul not co sional th their Technology istent on fusio All guideli y 21, 20 ntain organiza work. ). The regard recom nes an inform No 11. n ing re menda ation mercial benets tion and fou d paye trials co included so comm about ndation r polic party rel in any for me se mparin endatio tions medic ies wi fun ated dir m Analy t of al g of one ns for th reco tic ectly or have been ds were rec policy. fusion to othe the primary fundin support for mmen or will eived indire g from ra Howe of deve to supp thi dations ctly to be rec the AO s work wa ver, no r treatment op ndomized ort thi the su lo J.S.C. s provid s bject of eived from Spine, contro clear pa co tio Guideli pment was a co North ed by lled this ma stractio ntributed to identi ttern wi ns with the ne Spectru Ameri nuscript mexcept ed ba th rega ca. special s Research m Resea tribute n, policy co topic develop . sed ion and Ev rd to th lla d ty socie rch, Inc and M to policy co tion, review ment, gene aluation on the mod e ., with ty reco Conc .G ied Ap quality lusion mmen tool. Th ment (in . contribu llation, contr , and prima ral oversigh dations . Thre praisal ted t ry ere we that pr e syste discussi cluding mo to discussi ibution to int writing. M of article, da . of re diffe ovide matic .J.L. an died ta abon. A. on, ge roduc genera rences chroni L.E.P. reviews appraisa C.S. tio d E.M neral ov l gu in co c low . conl tool), contributedn and discu of evid lines res ntributed to ersight of back pa idance for ssion guidan syn ence-b to me the as in desc ce for ased gu proved ults, and co literature sea thods, an thesis of res methods de . B.A. se the ev ults, d da veloplla recom ideline the na rch aluation ribed consist ssment and menda s l draft tion of guide , informati ta abstractio contributio Addre treatm en on of chro of manu n to lin tions an n ss guideli ent nic low t recommen Vanderb correspon script. e recomme synthesis for and synthesis d guid nes wi dence ndation dations of ge ba ance fo th re of chro 37232; ilt Universi and rep s. All the neral guide . and r treatm ck pain but nic low commenda ty E-mail rin authors incons ent. tions : josep Medical Ce t requests across back pa apistent DOI: 10 h.cheng nte to guideli in were on the use of Five eviden .1097 @vande r, Medical Joseph S. Ch ce-bas nes regard /BRS.0 fusion evaluate rbilt.edu Center eng, M ed S144 b013e3 for the to deve and policies North d. Ther . 1822ef5 treatm www. , Nash D, MS, studies lopmen that ar e is so spinejou ent ville, TN b4 me co as we e gove t proc rnal.co ll as nsisten rnmen ess an Copyrig in spec cy t d criti ialty so overall reco ht 20 m cal ev sponsored wi the m mmen ciety 11 Lipp aluation th edical dations recom BRS2 incott m payer . There of inde the liter 04660. Willia policies endations. indd were di x ature S144 ms & Ther reviewe cited an ffe Wilkin d possi e is heterog rences d trans s. Una parenc eneity bly du uthoriz y of th e to va in ed repr e deve riations lopmen oductio in t proc n of th ess. A is artic
Joseph S. Cheng, M.D, MS, and his colleagues (Michael J. Lee, Eric Massticotte, Bryan Ashman, Marcelo Gruenberg, all M.D.s, and Leslie E. Pilcher, MPH, BA, and Andrea C. Skelly, Ph.D., MPH), sought to compare the quality and evidence base of fusion guidelines and select payer policies in a study called: Clinical Guidelines and Payer Policies on Fusion for the Treatment of Chronic Low Back Pain.
physician determination. Since guidelines and policies have impact on the definition of medical necessity, they decided to test the quality of those policies and guidelines. Payer policies define medical necessity and should be held to the same standards for transparency and development as guidelines, wrote the authors. The studys authors looked at PubMed, the National Guidelines Clearinghouse and the International Network of Agencies for Health Technology Assessment. They also searched Google for payer policies. They used an Appraisal of Guidelines Research and Evaluation instrument to provide a method for evaluating the quality of development of the evidence base.
Clinica
l Guid
elines
and Pa
yer Po le is pr ohibite licies d. ment o on Fusion fo r the T f Chro r nic Lo w Back eatPain
Octob er 2011
16/09/ 11 10: 18 PM
They began with the premise that the need for surgery based on literature is beginning to supersede
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The authors found that the general guidelines published through January 2011 were consistent with diagnosis, but inconsistent about treatment recommendations. Study Conclusions Three systematic reviews of evidence-based guidelines that provide general guidance for the assessment and treatment of chronic low back pain described consistent recommendations and guidance for the evaluation of chronic low back pain but inconsistent recommendations and guidance for treatment. Five evidence-based guidelines with recommendations on the use of fusion for the treatment of chronic low back pain were evaluated. There is some consistency across guidelines and policies that are government sponsored with regard to development process and critical evaluation of index studies as well as overall recommendations. There were differences in specialty society recommendations. There is heterogeneity in the medical payer policies reviewed possibly due to variations in the literature cited and transparency of the development process. [Emphasis added.] Or put another way, while the guidelines emanating from the surgeon societies are consistent in terms of diagnosing spinal disorders, they are inconsistent with regards to its treatment. Therefore the payers develop inconsistent payment policies and are able to pick and choose the guidelines that are in their best financial interest. This has led to the development of payer policies to temper the rise in
health care utilization that appear to conflict with local standard of care and clinical guidelines. Physicians who specialize in spinal care have found themselves challenged to provide their patient with what they believe to be the most appropriate and beneficial care in an increasingly difficult financial environment with decisions increasingly influenced by the conflicting interests of doctors, hospitals, and insurers. Such conflicts have raised questions on what constitutes the standard of care for a patient, and what defines the best available evidence to support it. [Emphasis added.] Physician Response David Polly, M.D. and head of spine services at the University of Minnesota told OTW that insurers/payers need to be as transparent as they are asking the surgeons to be about guideline development and treatment recommendations.
There is a presumed bias that payers will deny coverage in the absence of overwhelming data to demonstrate efficacya perpetually moving target. In order to preserve their own reputation they [insurers] may need to be even more forthcoming and err on the side of coverage rather than non-coverage since they are innately conflicted towards non-coverage, said Polly. Also at some point it should become a customers right to know how and what their coverage decision process is. Otherwise the presumption is that they are all like the Grisham novel/movie Rainmaker. Societies Respond Speaking on behalf of the North American Spine Society (NASS), Chris Bono, M.D., told us that the study highlights how guidelines are being used inconsistently. It points out that society data guidelines are not making it into
Doctors Gunnar Andersson and Chris Bono (left to right)
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payer guidelines. So payers are picking and choosing and are somewhat biased, said Bono. Gunnar Andersson, M.D., chair of the ISASS (The International Society for the Advancement of Spine Surgery) Public Policy Committee said the study raises concerns and also illustrates the lack of rigor and transparency in creating guidelines and performing health technology assessments. He noted the studys finding of inconsistencies in treatment recommendations between guidelines created, for example, by the American Pain Society and the Neurosurgical Societies and varying conclusions drawn by studies reporting outcomes following fusion surgery for degenerative conditions Most published reviews focus on the systematic review of primarily randomized controlled trials (RCTs). While these studies represent the highest level of evidence available, RCTs are not always feasible or practical to address surgical treatments. In addition, published studies are not reflective of more current fusion surgical techniques, added Andersson. Andersson said the remaining body of literature provides value to the evidence-based medicine discussion and is often discounted during the guideline development process. Payer Policy Discrepancies/Lack of Transparency A more serious concern, said Andersson, arose when reviewing medical payer policies, which revealed a high level of heterogeneity not only in recommendations, but also in the development process. Discrepancies were
found in the evidence used for policy development and there was a general lack of transparency. Some payer policies are based on guidelines that are not publicly available for review.
pies, by at least one national health plan: United Healthcare (UHC). He said this wasnt just an issue with fusion and cited the case of UHCs policy of non-coverage for lumbar artificial disc replacement. Such a policy of non-coverage seems unfair, in light of the robust randomized, controlled clinical trials supporting PMA [pre-market approval] approval of the Charit as early as 2004 and consistent data with published outcomes representing Levels I and II Evidence to support UHCs coverage, said Zigler. Continued Zigler, UHCs policy on artificial disc replacement, which states in the relevant part, Lumbar artificial total disc replacement is unproven for the treatment of single or multiple level degenerative disc disease in skeletally mature patients, is based upon
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While agreeing that there is always room for greater efficiencies, Andersson said, Spine fusion surgeries are increasingly being based on nontransparent assessments provided by consulting firms based on accounting principles, without input from the physician community or the totality of the evidence-based literature. Payer Variations For real world examples we went to Jeff Zigler, J.D., a reimbursement expert at MCRA (Musculoskeletal Clinical Regulatory Advisers. LLC). Zigler has noted variations (read: inconsistencies) in the standard of review for different thera-
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an inconsistent standard of review internal to the payer. In another example, Zigler said UHC coverage decisions for drug-eluting cardiac stents (DES) and bariatric surgery reveals inconsistencies regarding life-saving and life-enhancing therapy assessments. Despite demonstrating statistical significance in many objective categories of efficacy, sufficient to meet non-inferiority endpoints, UHC generally covers the use of DES, but specifically will not cover artificial disc replacement. Moreover, the medical communitys misgivings about late stent thrombosis in DES patients continue to prompt further investigation, and question the long-term durability of DESyet UHC covers DES in the interim, while those studies are conducted. This UHC interim coverage policy for novel, efficacious technology undergoing additional review and investigation has not been extended to disc. Lessons From Bariatrics Zigler says that UHC also seems to be remiss in seriously considering its option of covering cases performed at qualifying Artificial Disc Centers of Excellence, as in the case of bariatric facilities performing Lap-Band. Perhaps NASS, ISASS, AANS [American Association of Neurological Surgeons] and CNS [Congress of Neurological Surgeons] should take a page out of the playbook that professional bariatric societies used to secure limited LapBand coverage (American Society for Bariatric Surgery; Society of Gastrointestinal Endoscopic Surgeons). This might at least secure coverage for qualifying centers, and would have the ancillary benefit of tracking patient
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outcomes from around the country. Even if a Center-of-Excellence model is impracticable, payers like UHC could still allow coverage while the evidence for artificial disc replacement develops, which has clearly been afforded to other technologies like DES. An Imperative for Physician Role The authors of the study warn that transparency and complete disclosure of potential bias is required for credibility and compliance with any recommendations. A patient, physician, hospital, or payer must have complete confidence in the recommendations generated by any authoritative organization with respect to determining what is considered appropriate and beneficial medical care. Unfortunately, say the authors, at this time, there seems to be a void and
they feel that there is a pressing need for this in the era of health care reform and value-based medicine. Otherwise, the care of our patients may be dictated
more by economics and politics, than by what may be best to help our patients and ensure access to beneficial medical care. The authors of this article believe that as physicians it is imperative that we play a pivotal role in this.
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By Elizabeth Hofheinz, M.P.H., M.Ed.
Orthopaedic Crossfire Tackles Metal on Metal
Image created by RRY Publications, LLC. Source: Wikimedia - KaihsuTai and Current Concepts in Joint Replacement
Topic Metal-Metal: A Twilight Zone Where Weird Things Happen For the Proposition: Joshua J. Jacobs, M.D. Rush Orthopaedic Institute Chicago, Illinois Against the Proposition: Thomas P. Schmalzried, M.D. Joint Replacement Institute Los Angeles, California
Moderator: Thomas S. Thornhill, M.D. Harvard Medical School Boston, Massachusetts Dr. Jacobs: What better way to enter the twilight zone than to quote my favorite philosopher, Donald RumsfeldThere are known knowns, there are things we know we know, we also know there are known unknowns, etc. Its the unknown unknowns that have been the Achilles heel with some of these reconstructions. Its not all
bad newsthere are published studies with promising intermediate term results with both metal on metal (MoM) total hips and surface replacements. However, there are multiple reports of osteolysis aseptic loosening, soft tissue masses in MoM total hip replacement systems and also surface replacements that are possibly associated with hypersensitivity. To understand this we need to understand the fate of the debris that is generated from MoM bearings because I think this determines the ultimate soft tissue and local response. Not
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only do we have to deal with particles from wear but also free metallic ions that come off as a result of corrosion and colloidal organometallic complexes that form from these ions complexing with local proteins. Metal particles: we dont know as much as wed like. One MoM retrieval study showed that most of these particles are less than 50 nanometers. This is an order of magnitude smaller than polyethylene particlesmeaning that even though the volumetric wear rate might be less with MoM, the number of particles produced may be up to three orders of magnitude higher depending on what sizes you use for the calculation. It has also been shown that the chrome to cobalt ratio in periprosthetic tissue is reversed. It should be 1 to 2 in the alloy and its 9 to 1 or 5 to 1, depending on how you measure itso what youre actually seeing in the tissues is a preponderance of corrosion productseither those precipitated from metal ions or those from the nano debris that have been generated. Metal ions: we have found, as have other labs, that there are elevations of 10 20-fold in patients that have MoM bearings. But we dont know if there is any toxicity. Acute toxicity reported is rare, but there are reports from the UK showing a higher chromosomal aberration rate in patients with MoM bearings but the clinical significance is unknown and whether this is related to long term carcinogenesis is unclear. Data from our lab and others have shown that patients with MoM bearings do have a higher rate of hypersensitivity; the cytokine profile shows high levels of interferon gamma and IL-2, which are the signature cytokines for a Th1 response. This specific response leads to pro-inflammatory mediators that can actually upregulate the whole innate immune system leading to what I would call a
hypersensitivity induced osteolysis. This is different from the typical particle associated osteolysisthis may actually be mediated by a hypersensitivity reaction. Why discuss this? Because we are starting to see reports of these lymphocytic tissue reactions in these modern generation metal on metal bearings. In one study, pseudo-tumors were reported in 17 patients with 20 hips; the histology reveals necrosis and lymphocytic infiltration. This is a case of a pseudo-tumor, not with a MoM bearing but with a highly corroded stem showing necrosis of the tissues, the bone, and the corrosion products of massive necrosis. As was the case with ceramics, with MoM we cant throw out the baby with the bath water. Dr. Schmalzried: With regard to metal-metal the benefits include high stability and low wear; theyre unbreakable, and they form the foundation for a higher performance arthroplasty. There is a riska rare adverse local tissue response. And then there is the compared to what? Weve heard the debate on cross linked polyethylene and ceramic on ceramicthere is no risk free alternative. Its no mystery why both surgeons and patients have embraced metal-metal bearings. The high stability favors the larger diameter; metal-metal bearings work better and have lower wear as the diameter goes upthat gives you a higher, impingement free ROM and greater jump distance. And it enables resurfacing. Theres already documentation of very low wear in vivo for more than 30 years and no evidence of gross material failures. Showing a video of a rock climber, Dr. Schmalzried stated, This is a patient in my practice who said, Rock climbing is my passion, but I cant do it anymore.
Do you have a total hip that would allow me to return to rock climbing? We used a bilateral, 36mm on a standard new small generation trunion, giving him the ROM, stability, and strength he would need. There are more than 400,000 second generation implants worldwide with more than 20 years of follow up. There are several reports indicating no discernable difference in pain relief or clinical outcomes; and if you have a less than 5mm thick mono-block cup it conserves bone. You cant accomplish that with an ingrowth surface using either polyethylene or ceramic. Even within manufacturers there is variability in the process. The formula for low wear involves high carbon, large diameter, and small clearance; if its well made and well mated, it will do well. Its good in young patients; high activity does not influence ion levels. What does
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influence ion levels is urine volume. Quite simply, chromium excretion is a function of urine volume; if your patients want to decrease their circulating levels of ions, they should drink a lot. They will pee a lot, and they will pee out their ions. Youve heard that vertical cups dont do well with cross linked poly; youve heard that malpositioned vertical cups dont do well with ceramic on ceramic. The same is true for metal-metal. Higher wear is associated with vertical component positioning. The risk of high ion levels goes up with vertical component positioning; you need to avoid components at 55 degrees or higher regardless of the bearing. Large diameter does not compensate for vertical positioning, and there is some data indicating that excessive combined anteversion has a similar effect. What determines serum ion level? Component orientation (avoid vertical positioning); the loads and motion patterns will be different from patient to patient; the lubrication regime can be different; the wear mechanism, the presence or absence of any third bodies; non-bearing sources such as impingement and taper corrosion; and the ion excretion rate. Pseudo-tumors are not a new phenomenon. We need more information on the role of mechanics, and the role of corrosion. What is the incidence worldwide? There appear to be some centers that have a high incidence and other centers with a low incidence. My personal experience, through April 2008 with 571 hips having at least a 36mm bearing is that I have one patient with bilateral surface replacements who developed ALVAL [aseptic lymphocyte dominated vasculitis associated lesion].
I participated in three metal-metal surface replacement IDEs [investigational device exemption] with greater than 2,500 hips, minimum two year follow up; none of those have been revised for an adverse immune response. I dont want anyone to think that Im not concerned about the rare local immune response. If there is anything weird going on it has to do with the fact that the incidence appears to be quite variable from center to center and region to region. We must identify risk factors from an implant, patient, and surgical technique perspective. But it is my position that if a bearing is well made and well mated it will do well. Moderator Thornhill: Tom, which is more high performance, a conventional femoral stem, large head, metal on metal, or a resurfacing? Dr. Schmalzried: This isnt a debate about resurfacing. You can get the same level of performance from either type of arthroplasty if the reconstruction is mechanically done well. Moderator Thornhill: Josh, do you do use MoM hips? Dr. Jacobs (hesitating): Uh, no. Moderator Thornhill: Tom, what do you tell your patients about the downside of a MoM hip? Dr. Schmalzried: I make sure they understand that there are possible local tissue reactionsand I tell them that Ive only had one such case. Moderator Thornhill: Josh, what are you doing now and what can you tell us from your results so far?
Dr. Jacobs: We should distinguish pseudo-tumors from metal hypersensitivity. Its unclear what the pathogenesis of these pseudo-tumors are, and to what extent they may or may not be related to hypersensitivity. Weve seen pseudo-tumors around metal on polyethylene. But it seems to be more prevalent with metal on metal (anecdotally). In terms of systemic testing, there are various ways that we have tried in a laboratory to determine whether the patient might be hypersensitive to metal, but that may or may not be predictive of whether they get a pseudo-tumor. This is going to require extensive researchand we should try to get an idea if there are some peripheral markers that can identify them even before surgery. Moderator Thornhill: Tom, I know everyone in southern California wears 24 carat gold, but the bling in Boston has a lot of alloys. When you have a patient saying they have metal sensitivity, what do you do? Dr. Schmalzried: I screen for overall allergic history and a cutaneous metal allergy history specifically. If someone has a long list of allergies I tell them, I think that youd be better off with an implant that doesnt have cobalt chromium molybdenum nickel alloy. If someone says they have a ring or bracelet that gives them a rash or redness I say, I think youd be better off with something that doesnt contain that alloy. Moderator Thornhill: Its a problemI agree. Dr. Schmalzried: But it may be one of the reasons why its low in my practice because Ive avoided people with an allergic propensity.
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(modular junctions) can be an additional source of debris generation. And in addition the debris generated from these can accelerate third body wear at the articulation. So Im afraid that we may see even more complications in those reconstructions that have more than one or two modular junctions, so its something to avoid if at all possible. Dr. Schmalzried: But theres no data at this point to indicate that the risk is increased, right, because all the surface replacements are monoblock implants? Dr. Jacobs: There is no clinical data yet; however the current generation of some of these modular neck body stems has not been around long enough to generate that data. Moderator Thornhill: Tom, concerning systemic toxicity, people say dont do it in a woman of childbearing age or someone with renal failure. What are the things that you avoid in terms of systemic toxicity? Dr. Schmalzried: Theres no reason to do it in a patient with renal failure. If its a woman of childbearing age, I have a frank discussion with the patient about whether the benefits outweigh the risks. In the resurfacing trials weve had a number of women who became pregnant, went to term, and delivered healthy babies, so again we have not seen a problem in that age group. Moderator Thornhill: Thank you both.
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Moderator Thornhill: I solve it by not doing metal on metal and sending the patient to someone who does. Josh, if youre going to do metal on metal should you avoid modular stems?
Dr. Jacobs: The problem with implant debris and metal debris in particular is that the effects can be cumulative and additiveand may be synergistic. The trouble with modular stems is that that
Please visit www.CCJR.com to register for the upcoming 2011 CCJR Winter Meeting, December 7-10 in Orlando, Florida and the 2012 CCJR Spring Meeting, May 20-23 in Las Vegas, Nevada.
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Reporters Notebook
By Elizabeth Hofheinz
Dear OTW Reader: Committee of 12 with a bulls-eye on healthcare? New hires at K2Mout of the way, FDAWhat Peter Indelicato, president of AOSSM, is excited about, and oh,hear what happens when some Viscogliosis go hunting. (Hint: no one was shot in a small bone) Hospitals, Nonpayment, and Hypercaution Dr. Donald Shelbourne, founder of the Shelbourne Knee Center in Indianapolis, tells OTW, There is a lot of talk about the checklist manifesto these daysmeaning, that soon Medicare will put its foot down and will not pay hospitals for the cost of treating preventable complications. The cost of treating an infection is ten times the cost of a total knee. So hospitals are now on alert, and more than ever are trying to ensure that nothing happens that is preventable. Hand sterilization is being stressed more than ever, and at least one hospital I know of has implemented a rule that the plan for a patient must be reviewed in the holding area before surgery so as to prevent things such as wrong site surgeryand its a surgeon, not a fellow, who has to sign the site. These things are clearly what we have needed for a long time. And the wave is such that once Medicare starts saying they absolutely wont pay for preventable conditions, then all the other insurers will as well. Its going to make everyone even more cautious. Take DVT [deep vein thrombosis]if someone develops a clot and the person had not been on an anticoagulant,
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then that is preventableand it wont be covered. The spine masters at K2M, Inc. have brought three new senior international hires on board. Larry W. Found, senior vice president, global human resources, has more than 20 years experience in the medical device industry. Found was formerly a Captain in the Canadian Army, a role which included commitments to the UN and NATO. Gianluca Iasci, senior vice president of international, also has more than two decades of experience within the medical device industry. Iasci served as senior vice president of international at AGA Medical and served for 12 years with Johnson & Johnson in various Italian and European sales and marketing positions. He also was the managing
director of Italy while at Guidant, now Boston Scientific. Carol Pinto, area vice president, Latin America, has more than 25 years of experience in sales and marketing leadership for companies in the spine and medical implant industry including Orthofix Spine (Blackstone Medical) and Surgical Dynamics, Envision. Keeping Young Athletes in the Game Peter Indelicato, M.D., president of the American Orthopaedic Society for Sports Medicine, tells OTW, Sports medicine specialists are excited that the STOP Sports Injuries campaign (www. stopsportsinjuries.org) is starting to develop a life of its own. We have had a huge increase in member involvement and growing corporate sponsorship its not hard to support this program
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its like apple pie and the American flag. Who wouldnt want to support a serious, coordinated effort to diminish the frequency and incidence of injuries in young athletes? The most exciting thing is that we are keeping kids in the game for life. Sometimes the game doesnt like kids as much as kids like the game, but I am proud to say that we are changing that. Wright: New Senior VP and COO And the bullhorn goes toJulie D. Tracy. Tracy is the new senior vice president and chief communications officer at Wright Medical Group, Inc. She brings more than 25 years of experience in the medical device industry in investor relations, corporate communications and marketing. She has been chief communications officer for Epocrates, Inc. and senior vice president and chief communications officer for ev3 Inc.;
she has also held marketing and investor relations positions at Kyphon Inc. and Thoratec Corporation. Improving Spine Care in Africa Saving spines and livelihoods in the CongoRichard Kaul, M.D. is the founder of New Jersey Spine & Rehabilitation in Pompton Lakes, New Jersey. In his other life, he is the creator of the Spine Africa Project, a project bringing more advanced spine care to the Congo. Dr. Kaul is not only performing surgery and educating healthcare providers, he is helping to support patients economically. How? Because if the family breadwinner sustains a serious injury they often cannot work; they and their families can become destitute and can no longer contribute to their communities. Dr. Kaul is raising money to begin bringing equipment, such as a backup generator and sterilization equipment,
to the Congo. The Spine Africa Project is holding its first fundraiser in New York on Nov. 12, with the hopes of raising enough funds to cover its December trip. Those interested in learning more about the project can visit the website at www.spineafricaproject.org/ Transition for Bill Sterett, M.D. Bill Sterett, M.D., former managing partner of the Steadman-Hawkins Clinic, has joined the practices of Vail-Summit Orthopaedics. The knee and shoulder specialist has been treating patients in the Vail Valley for more than 18 years. Dr. Sterett, one of the few Colorado surgeons fellowship-trained in both sports medicine and orthopedic trauma, has been the U.S. physician for past three winter Olympics and seven World Alpine Ski Championships. He is also the author of 30 peer-reviewed publications and has patents on some of the most commonly used joint preservation systems in orthopedics. Gunning for Healthcare A certain veteran orthopedist thinks that the governments Committee of 12 has a bullseye on healthcarethis surgeon tells OTW, Healthcare expenditures exceed defense expendituresand almost any other piece of pieso its unlikely that we wont see cuts. The Medicare population will be increasingly left out if the committee goes through with the large cuts they are planning. Specialists in particular will soon be opting out of Medicare; granted, we could end up with a situation where a certain portion of a doctors time is legally allocated to Medicare patients. But, from the patients perspective, no one wants to see a physician who doesnt want to see them. If they go ahead and reduce reimbursement rates by 6% a year for three years, thats one thing. But thats not the casetheyre not saying, Were
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in trouble today, but well give it back to you in a year. They are saying, We are in trouble today, but were never giving it back. You know that wouldnt happen to lawyers, postal workers, etc. North Shore Expands NorthShore University HealthSystem in Illinois has welcomed the physicians of Northwestern Orthopaedic Institute, LLC (NOI) into its system of care. In the past year, NorthShore has added 12 physician practices and more than 40 new physicians and thousands of patients. Part of this integration is a planned joint neurologic and orthopedic spine care program. This partnership will enhance the future of spine care by offering comprehensive expertise and the latest technology and treatment including operative, non-operative and minimally invasive options, said Srdjan Mirkovic, M.D., NOI spine surgeon, in the news release. FDA a Hindrance A certain frustrated orthopedist could not contain his annoyance. He recently told OTW, The FDA has raised the bar for new devices and biologics to the level where it is nearly impossible for new safe technologies to emerge for the benefit of our patient. There are viable emerging technologies languishingtechnologies that could otherwise help suffering patients. But this monolithic entity is creating such awful, and at times, irrational, roadblocks that it is nearly impossible to overcome them in contemporary medicine and economics. Even well-funded and intended projects are having problems. As a general rule, if the FDA can implement rational guidelines, then funding and research would likely lead to viable technologies to solve very difficult clinical problems that continue to plague our patients. Concerns for job preservation may exceed concerns for
If you havent already saved the date of February 21, 2012, mark your calendar now. And if you want to ensure your spot at 2012s Stem Cell Summit AND save more than $500, take advantage of our low early bird registration rate today. Preregistration is now open!
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evolutionary and safe developments of emerging technology. A Viscogliosi Goes A Huntin Armed with experience in backwoods Michiganoh, and a large rifleJohn and Marc Viscogliosi (now city boys) recently went on a hunting excursion with a friend. John Viscogliosi told OTW, We were out in Colorado, and it was our first time elk hunting. The first day we saw a large elk but we didnt get in any shots. On the second day I spotted an elk in a thicket of Aspen trees. Our friend saw the rack on the elk and said, You have to get this one. I was about 80 yards awayand I actually dropped it in one shot. Apparently, this is exceedingly rare. Our hunting mate told me that of the 36 elk he had gotten in the last four years he had only dropped one with a single shot. The antlers are soon to be delivered to my
office in New York, something that should liven up business discussions. As for the meat, it was processed into sausage, roast jerky, etc. Rothman Participates in New Surgery Center Riddle Surgical Center, a multi-specialty ambulatory surgery center located in Media, Pennsylvania, has recently celebrated its first anniversary. The center was developed by area physicians, Main Line Health Systems, The Rothman Institute, and Nueterra Healthcare to provide patients with high-quality, patient-focused surgical care. The 17,500-square-foot facility offers four fully-equipped operating rooms and two procedure rooms with the latest medical instrumentation. In addition to orthopedic surgery, it is equipped for ENT, Gastroenterology, General Surgery, Ophthalmology, Pain Management, and Podiatry.
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company
Smith & Nephew Revenue Grows 10% in 3Q11 TABLE
ed by knees, Smith & Nephew reported on November 4 that company revenue grew 10% in the third quarter to $1.032 billion. On a constant currency basis, knees rose 6%, while the hip business shrank by 2%, reflecting concerns about metal-on-metal technology. Trauma was up 4% Orthopedic sales (consisting of reconstruction, trauma and clinical therapies) grew by 1% in the U.S. and 6% outside the U.S.
Smith & Nephew 3Q11 Sales % ($ in millions) Change*
The slip in the global hip business was attributed to continued strong headwinds of the companys Birmingham Hip Resurfacing System (BHR). This, says the company, was despite the continuing strong data on BHR, where
The story in orthopedics however, was pricing pressure that reduced the companys margins down to 15.6%. The shrinking margin was attributed by the company to continuing adverse sales mix, high periodic costs, and the need to reduce costs to better reflect market conditions. Bohuon Comments Olivier Bohuon, who became chief executive in April, said he was disappointed with the margin. Our cost base in orthopedics was too high, he told reporters on November 4 analysts Smith & Nephew conference call. We have to adapt to meet market challenges we are all seeing lower growth and greater pricing pressure. We have been addressing this issue but we did not do this fast enough. The company said it still expected to grow full-year revenue in orthopedic reconstruction, sports medicine and advanced wound management faster than the market. Bohuon concluded, In August we announced our new strategic priorities to maximize growth and margins. The new operational management teams have embraced these and together we are developing the action plans that will liberate the resources needed for re-investment and to protect our underlying margins. With high levels of energy and determination, we are reshaping Smith & Nephew to thrive in the future. WE (November 4, 2011)
recent registry Total Sales $1,032.0 5.0% data in Australia and NICE Ortho/Trauma $548.0 3.00% data in the UK Endoscopy $226.0 7.0% demonstrated Advanced Wound Management $258.0 5.0% industry-leadSource: Smith & Nephew ing high long* On constant currency basis term survivReconstruction revenues grew by 2%, ability. In traditional hips, the company ahead of, according to the company, the saw double-digit growth in revenues estimated global market growth rate of from products featuring the proprietary 1%. It was the companys fifth consecu- Oxinium bearing surface. tive quarter of market outperformance. In the U.S., growth was flat, while out- The 4% trauma growth was against an side the U.S., sales grew 5%. In Europe, estimated market rate of 6%. The comgrowth was 2%. pany said it saw strong growth in sales for the Limb Restoration external fixaThe company said the global knee fran- tion devices and internal fixation ranges chise delivered market-leading growth such as Trigen Intertan nails and the driven by a strong portfolio of implants Peri-Loc Variable-Angle Locked Plating and instruments. In the U.S., the growth System. rate eased to 5%, partly reflecting the annualizing of new products launched Clinical therapies revenues grew 7% last year, while outside the U.S., the with the Exogen Bone Healing System company saw a 6% increase in sales. growing strongly.
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Wright Medical 3Q: Ailing, Taking Medicine TABLE
right Medical Group, Inc.s third quarters sales declined 3% to $118.2 million. The company also announced it was reducing its revenue guidance by $12 million to $24 million for the entire year. It was new CEO and President Robert Palmisanos first opportunity to address Wall Street analysts during his first investor call on November 1. On a reported basis, hips, knees and biologics declined 2.3%, 7.9% and 15.5%, respectively. The one bright spot was Extremities , growing by 7.5%
Wright Medical Group, Inc. 3Q11 Total Reported Sales Hips
Wikimedia Commons and U.S. Navy photo by Mass Communication Specialist 1st Class Carmichael Yepez
Sales ($ in millions) $118.1 $39.0
% Change down 2.9% down 2.3%
operational costs.
My top priorities will be Extremities $32.3 7.5% to continue Knees $27.2 down 7.9% building on Biologics $16.6 down 15.5 this progress Other $2.9 22.4 and focusing Source: Wright Medical Group, Inc. on areas where we can win, including growing our foot and ankle New CEO Meets Wall Street business above market rates, running Palmisano said, We are clearly facing a much more focused and efficient some challenges, which are reflected recon business, and improving our balin our third quarter results and our ance sheet to increase cash generation, outlook for the remainder of the year. added Palmisano. However, Wright Medical is a company with great promise. We have excellent Palmisano addressed the reduction in products and technologies across our revenue guidance by saying, In resetorthopaedic businesses, and we are the ting our guidance, we took into account recognized leader in the foot and ankle the factors that are expected to affect market. In addition, we have recently our business for the remainder of the taken many positive steps to better posi- year, including procedure softness tion the company for success, including globally, as well as challenges associatstrengthening our compliance program ed with implementing enhancements to and implementing a plan to reduce our compliance processes and distribu-
tor transitions. I am confident that we will be able to capitalize on the market opportunities and work towards building a leading global orthopaedic organization. The company reported a net loss of $16 million in the quarter versus a profit of $4.7 million a year ago. Net income for the quarter included about $36.4 million in charges for assumed liability for device claims, restructuring plans, deferred prosecution agreement and other items. BMO Capital Market Analyst Joanne Wuensch said she suspects the quarter and lowered guidance is a, kitchen sink move by new management, and that this is a team that can make heads or tails of this mess. She added the fervor that arrived with Bob Palmisano is warranted, but it may take longer to see the results investors are expecting. WE (November 4, 2011)
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NuVasive 3Q11: Noisy and Upward
lawsuit with Medtronic, an acquisition of a monitoring technology and nearly doubling the companys outstanding number of shares from 70 million to 120 million highlighted the third quarter for NuVasive, Inc. Revenue Up 10.5% The company also reported a 10.5% increase in revenue to reach $132.9 million. Due to higher operating expenses attributed to litigation liabilities and additional costs associated with higher revenue and infrastructure expansion, the company reported a net loss of $67.6 million for the quarter. Cash, cash equivalents, and short- and longterm marketable securities were $418.9 million at September 30, 2011. Alex Lukianov, Chairman and Chief Executive Officer, said, Our financial performance in the third quarter of
2011 attests to exceptional execution by the NuVasive team. In the face of an extremely challenging spine market, we delivered industry leading growth and executed a strategic transaction that will enhance the penetration of XLIF and NeuroVision for years to come. Our Impulse Monitoring acquisition increases our Intra-Operative Monitoring platform, allowing us to offer surgeons and hospitals complete procedural solutions in all areas of spine We will continue to remain laser focused on pushing toward our next milestone of being a $1 billion company with increasing profitability to serve the needs of spine surgery patients. Noisy Quarter BMO Capital Markets Analyst Joanne Wuensch said this was, a VERY noisy quarter for NuVasive, after a Medtronic patent loss, weak European revenue, delayed FDA products, and the closing of a significant acquisition (Impulse Monitoring). Despite this, the companys revenue increased 11%, taking
market share, in a spine market that is noted as stable (or flat to slightly down). Management continues to drive for above market growth rates and a goal, longer term, of at least 15% top-line growth heading toward $1 billion in revenue and 20% operating margins. The Spine Journal Biologic Backlash Wuensch said management told analysts that biologics sales were not as robust as expected in the wake of The Spine Journal issue on Medtronics Infuse and a backlash on biologic products, in general. According to Wuensch, management believes that the spine landscape is stabilizing, as surgeons learn to navigate the environment and could return to mid-single-digit growth. The surgeon community continues to work through the restrictive guidelines on spine surgery. Citing a win over the State of Florida Medicare Board, a case where the company immediately engaged the surgeon community to request reversal of the non-coverage decision, the changes recommended by AANS were for the most part accepted, insuring patient access to appropriate care. NuVasive, according to Jefferies Analyst Raj Denhoy, is far and away the fastest growing spine company and continues to take significant share, even in the face of numerous competitive launches. While the market is still tough, the trend toward minimally invasive surgery and the dislocation among the larger companies are both working in NuVasives favor, said Denhoy. Onward and upward, as they like to say at NuVasive, can be noisy.
NuVasive Headquarters/NuVasive, Inc.
WE (November 1, 2011)
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Orthofix Beats Market and Expectations in 3Q11 TABLE
rthofix International NV set a record for quarterly revenue in the third quarter. Reported sales rose 4% to $144.7 million while beating revenue and earnings consensus. Currency contributed 2.6% to total sales. Flat Spine Sales performance included an 8% increase in implants and biologics revenue. The stimulation products used in spine applications decreased 8%. However, the company reported that
Orthofix Internatonal NV 3Q11 Total Reported Sales Spine Stim Implants/Biologics Total Spine Orthopedic Sports Medicine
Wikimedia Commonsand Orthofix International NV
Sales ($ in millions) $144.7 $39.7 $36.8 $76.5 $40.8 $25.6
Source: Orthofix International NV
stimulation sales were up sequentially over the second quarter of 2011. Management told analysts on October 27 that the year-over-year decrease in total spine sales was primarily a result of slowing industry-wide surgical procedures and organizational changes within their sales force. Orthopedics on the Rise Orthopedic product sales rose 16%. The increase was led by the companys hardware platform and the increased use of Trinity Evolution in orthopedic applications but was partially offset by the reduction in stimulation products used in long-bone applications.
President and CEO Robert Vaters, % Change commented, We 4.0% continue to deliver strong profitability down 8% and top-line growth 8.0% amidst industry down 1% headwinds. At the 16.0% same time we are 8.0% upgrading talent and focusing our pipeline investments. I expect these improvements to continue as we resolve our pending legal matters and increase our investment in new products. Mizuho Securities analyst Mike Matson said Orthofix is growing well above the spine market which he estimates declined by 3% on a constant currency basis during the quarter. Matson thinks the company can continue to outpace the market given its small size, new products (deformity, MIS, and PEEK spacers), and geographic expansion. Jefferies analyst Raj Denhoy expects Orthofixs revenue to grow in the midsingle-digits over the next couple years,
due to broad market challenges (pricing, volumes, reimbursement, etc.) coupled with headwinds in spine stimulation. WE (November 1, 2011)
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Zimmers 3rd QuarterSteady Growth, Waiting for Patients
immer Holdings, Inc. reported a 7% rise in sales to $1.031 billion for the third quarter of 2011. Hips led the way, rising 10% to $315 million. Knee sales reached $417 million, rising 3%. Spine lagged, dropping 2% to $55 million. Extremities and Trauma rose 7% and 19% respectively, all on a reported basis. The companys reconstructive sales division reported a 6% increase in sales.
Analysts summarized the quarter with phrases like, decent given the environment and in-line with expectations. Analysts also noted, given Zimmers results, the anticipated recovery of the orthopedic market will not take place in the second half of 2011. Ortho Market
Zimmer 3Q11 Total Reported Sales Reconstructive Knees Hips Extremities Spine Trauma
Based on actual results from Biomet, DePuy, Stryker and Zimmer, and estimates for the other companies, Mike Matson of Mizuho Securities, estimate that on a constant currency basis, global recon growth was 1% in the third quarter, up slightly from 0% in the second quarter. He estimates that, on a constant curSales rency basis, global knee % Change ($ in millions) growth was 0% and $1,031 7.0% global hip growth was $768 6.0% 3% during the quarter.
$417 $315 $36 $55 $69 3.0% 10.0% 7.0% down 2% 19.0%
of sales, posted negative growth. Outside the U.S., the company posted better growth owing to its market development efforts. The company has all but written off 2011 with hopes pinned on a resumption of growth back to the mid-single digits, wrote Denhoy. In the interim, as it waits for the turn, rather than pursue more aggressive strategic initiatives, Denhoy says Zimmer appears content with continued investment in its selling infrastructure and supporting earnings through aggressive share buybacks. Dvorak: Procedures Will Return Zimmers President and CEO, Dave Dvorak told analysts during a conference call on October 28, that demographics dictate that customers will be back when they stop fearing losing their jobs. During a question and answer session, Dvorak said, These procedures will come back. And I think that people are just being pretty careful across the industry at projecting when theres going to be a pickup in those procedure rates. But we know those cases are out there. Dvorak continued, You even saw a bit of an uptick on the hips side sequentially from Q2 to Q3 of this year. And I think thats a sign that those procedures are still out there. I mean, the economy didnt get healthier. Consumer confidence didnt improve, but the need that those patients have broke through that barrier, and we saw a little bit of on uptick. I think the same thing will happen in knees, and its difficult to predict which quarter it will begin to occur. But those patients are still out there.
Source: Zimmer Holdings, Inc.
Raj Denhoy of Jefferies & Co. wrote that the orthopedic markets remain anemic. He noted that Zimmers U.S. recon businesses, which represent 40%
Hospital Waiting Room/Wikimedia.org
WE (October 28, 2011)
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Integra Introduces New Surgeon Lights
College of Surgeons Annual Clinical Conference in San Francisco. Company officials describe the system as one that provides vibrant color rendition that maximizes visualization of critical anatomy across a broad range of surgical procedures. Its 25,000+ hour lamp life ensures a dramatically longer life than the more traditional xenon surgical lighting systems, which have a lamp life of approximately 1,000 hours. They note that the LED Headlight System also provides greater mobility with either a lightweight 20-foot power cord (that eliminates the clutter of floor stands and fiber optic cables), or a light weight battery option that allows surgeons untethered mobility within the operating room. We expect surgeons will welcome the same low cost of ownership, cool output and extremely long life thats helping LEDs become the standard in other markets. In addition, this self-contained headlight does not require fiber optic cords, introducing surgeons to a new level of independence, by allowing them to move more freely about the operating room, said Dan Reuvers, president, Instruments.
urgeons havta, gotta see what they are doing. Responding to that imperative, Integra LifeSciences Holdings Corp. has introduced a new surgical headlight system that, according to Integra, is designed to deliver the cool brightness and color needed for visibility along with increased mobility in the operating room. Called the LED Headlight System, it has received 510(k) clearance from the FDA and is being featured at the American
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BY (October 28, 2011)
legal
Whistleblower Costs DFine $2.39 Million for Kickbacks
whistleblower has struck San Jose, California-based DFine Inc.
The U.S. Department of Justice (DOJ) announced on October 26 that DFine Inc. has agreed to pay $2.39 million to resolve allegations under the False Claims Act that the company paid kickbacks to induce physicians to use certain of the companys devices.
The government said DFine paid physicians up to $500 per patient to participate in customer surveys known as User Preference Evaluations (UPE). Each UPE survey required use of a new DFine device in a patient. Thus this was an illegal kickback to induce [physicians] to use the companys vertebral augmentation devices. The government alleges that DFine provided improper remuneration in the form of travel expenses, lavish dinners, entertainment and promotional speaker fees to doctors located in Chicago
Source: Department of Justice and DFine Inc
and Little Rock, Arkansas. The government further alleges that DFine solicited physicians to convert their business from a competitors product and/ or persuade the physicians to continue using DFine products.
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Decisions about devices used to treat serious spinal conditions should be based on the best interests of the patient, not on whether the manufacturer is going to pay a kickback, said Tony West, Assistant Attorney General for the Justice Departments Civil Division. These sorts of improper financial incentives not only undermine the integrity of medical decisions, they also waste taxpayer funds and are unfair to competitors who are trying to play by the rules. This action was initiated by the filing of a qui tam, or whistleblower, action under the False Claims Act by Brian Eberhard. The act permits a whistleblower to file a lawsuit on behalf of the government and share in any recovery. In this case Eberhard will receive approximately $250,000. Also as part of the settlement, DFine has agreed to enter into an expansive corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. That agreement provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which allegedly gave rise to this matter, stated the government announcement. The Justice Department has used the False Claims Act to recover more than $5.9 billion since January 2009 in cases involving fraud against federal health care programs. The Justice Departments total recoveries in False Claims Act cases since January 2009 exceed $7.8 billion. The company issued the following statement regarding the settlement. DFine fully cooperated with the investigation and continues to deny all of
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DOJs unproven allegations. The terms of the agreement specifically state that DFine and its employees admit no
wrongdoing, liability or illegal activity. The decision to settle prior to completing the full investigation was a very dif-
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ficult one, but one we felt was best for the company based upon the significant disruption and associated costs to continue the investigation, as well as the uncertainty regarding its duration. WE (November 3, 2011)
September 2011 FDA Approval Summary
Ceramax Ceramic Total Hip System and is indicated for noncemented use in skeletally mature individuals undergoing primary total hip replacement surgery for rehabilitation of hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, and post traumatic arthritis. EBIs Bone Healing System The second was for EBI, LLCs EBI Bone Healing System. Supplemental approval was for the replacement of an analog electrical isolation tester with a digital electronic isolation tester, and addition of a manual hand-soldering process as an alternative to the existing automatic soldering process. PMA/Supplemental Approval Summary A summary of the FDAs September PMA/Supplemental activity was as follows:
reader recently asked us to give a monthly update of PMAs (premarket applications) or supplemental approvals that were issued by the FDA during the past month. In September, the FDA approved one original and 81 supplemental applications. The original approval was for Pluromed, Incs LeGoo, a device indicated for temporary endovascular occlusion of blood vessels below the neck up to 4 mm in diameter. There were two orthopedic related supplemental approvals. DePuys Ceramic Hip The first was for DePuy Orthopaedics, Incs Ceramax Ceramic Total Hip System. Supplemental approval was for the addition of the Trio-Lock BPS (Bone Preserving Hip Stem) and 28 mm ceramic femoral heads with a 12/14 taper and +1.5 mm, +5 mm, and 8.5 mm offset as compatible modular components to the system, and minor labeling changes to the device package insert and surgical technique. The device, as modified, will be marketed under the trade name DePuy
Total number of PMA Originals under review - 94. Half are active and half are on hold. Three applications have been under consideration more than 180 days. Total number of PMA Supplements under review - 585. Of those, 430 are active and 155 are on hold. Eleven are older than 180 days. For the year, 81 PMAs or Supplements have been approved and 0 have been denied. The average number of days to a final decision from the receipt of the application was 118 days. The FDA received two new PMA and 69 Supplements applications during the month. To view the FDA Web site, click here: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ D e v i c e A p p ro v a l s a n d C l e a r a n c e s / PMAApprovals/ucm277367.htm WE (October 27, 2011)
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extremities
New Tool for Early OA Assessment
srael-based BeamMed has announced that its Sunlight MiniOmni bone sonometer has been cleared by the FDA and can now be marketed in the U.S. Recently, the Sunlight MiniOmni also received a medical device license from Health Canada. The Sunlight MiniOmni device received CE mark clearance in October 2010. To date, BeamMed has sold hundreds of Sunlight MiniOmni systems worldwide. Now that the North American market has been opened to us, we expect to see strong sales of the Sunlight MiniOmni, similar to the success we are achieving in Europe, Asia and the Far East, said Mr. Tal Marom, CEO, at BeamMed, in the November 3, 2011 news release. As indicated by the company, the Sunlight MiniOmni bone sonometer provides an exceptionally affordable, professional solution for early assessment of osteoporosis. It enables reliable, accurate, non-invasive and safe monitoring of bone density at the point of care. Its small size and weight, intuitive ease of use, and convenient USB-port con-
nectivity to Windows-based PCs and laptops make it ideal for use in any physician office or medical clinic, pharmacy, annual checkup center or other retail venue. Sunlight MiniOmni is based on the same proprietary quantitative ultrasound technology that has been proven in thousands of Sunlight Omnisense installations worldwide. EH (November 3, 2011)
BeamMed
New Options for Damaged Ankles
rthrosurface, Inc., a Franklin, Massachusetts company engaged in the development of joint resurfacing systems. In Europe, the company has launched a resurfacing system for damage to the ankle. Named the HemiCap Talus Resurfacing System, the process has been clinically evaluated by foot and ankle surgeons throughout Europe for the past four years. Arthrosurface officials report that over 100 patients who had received their implants, when asked, reported a high level of satisfaction. According to Dr. C.
Wikimedia Commons and Nevit Dilmen
CAP system offers a promising new solution for those patients who have failed their primary treatment. For these young and active patients it is important to restore the damaged area in order to protect the underlying bone and prevent further cyst formation. I am very encouraged by our clinical results over the last four years.
Niek van Dijk, Department of Orthopaedic Surgery, University of Amsterdam, Metallic implantation with the Hemi-
Focal defects of the talar dome are often caused by trauma and result in deep,
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cup-shaped lesions. This incongruity of the joint surface and resulting cartilage damage often alters contact stresses in the ankle joint and can lead to the development of painful cysts deep within the bone. It is these cysts and fluid pressure on areas of exposed bone that causes significant pain and debilitation. Dr. Ned Amendola, professor of Orthopaedics and director of Sports Medicine at the University of Iowa, notes that, The HemiCAP Talus Resurfacing System allows surgeons to restore the damaged surface of the talar dome by reproducing three surfaces with one implant, namely the dome, ridge and medial wall. In our study we showed that the HemiCAP Talus System reapproximates the native geometry of the talar dome providing a load sharing surface to help protect the remaining rim of good cartilage. Previous alternatives available to patients after failing their primary treatment were to opt for total ankle replacements or ankle fusions. An ankle replacement removes a significant amount of bone and has a higher risk of failure than other joint replacements and fusion permanently eliminates the movement of the ankle joint. The HemiCAP Talus implant, when successful, gives patients another option that is less invasive, preserves the joint and allows for normal activity. The Arthrosurface HemiCAP Talus System offers over 150 different sizes and shapes to effectively cover the damaged area and match the contours of the patients joint surface. BY (October 28, 2011)
spine
JBJS: Timing of Lumbar Surgery
ont delaycall the number on your screen now! Well, just dont delay treatmentA new study in the Journal of Bone and Joint Surgery (JBJS) has found that patients with herniated lumbar disc symptoms were significantly worse if the patients had symptoms for more than six months prior to treatment, compared to those who had symptoms for six months or less. Patients often ask their physicians whether the duration of their symptoms will affect their potential for a full recovery, and the goal of our study was to address this question, said orthopedic surgeon Jeffrey A. Rihn, M.D., in the October 25, 2011 news release. According to our study and generally speaking, patients who had symptoms for more than six months had less
improvement in pain, function, general health, work status, and patient satisfaction, added Dr. Rihn. The study authors observed 1,192 patients enrolled in the Spine Patient Outcomes Research Trial (SPORT), which was conducted at 13 multidisciplinary spinal practices in 11 states. The patients were older than age 18 and suffered from various symptoms of lumbar disc herniation. Patients were assigned to undergo either operative treatmentlumbar discectomyor nonoperative treatmentsuch as physical therapy, education, a nonsteroidal anti-inflammatory drug, and/or counseling with home exercise instruction. The researchers analyzed the outcomes of the operative and nonoperative treatments. They compared the treatment outcomes of the 927 patients who had symptoms for six months or less to those of the 265 patients who had symptoms for more than six months prior to enrolling in the study. At all follow-up intervals, outcomes were significantly worse in patients who had symptoms
Wikimedia Commons and A E Francis
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for more than six months prior to treatment than in those who had symptoms for six months or less. Dr. Rihn told OTW, I think there were several interesting findings from this study. First, we found that the duration of symptoms from a symptomatic lumbar disc herniation seems to have a significant effect on the outcome of treatment, whether it be nonoperative or operative treatment, with those having greater than six months of treatment gaining less benefit over their baseline status compared to those with less than six months of symptoms. Also, however, it is important to note that even patients with greater than six months of treatment still get significant improvement with surgery, and that surgery still has a significant advantage over nonoperative treatment in those patients with a longer duration of symptoms. EH (October 31, 2011)
Spineology Launches own Fusion Device

ith FDA clearance firmly in hand, Spineology, of Saint Paul, Minnesota, is launching its first lumbar interbody fusion device into the market. Called the Rampart Interbody Fusion System, the product has been under development for more than a year, according to Dan McPhillips, vicepresident of marketing. Rampart is a great synergistic fit for our growing product line. He said, adding that the Rampart System includes a variety of configurations, length and heights, to provide surgeons with a variety of options to help them meet the needs of their patients. The system is configured with implantation equipment that is designed to assist the surgeon in positioning the implant within the disc space.
McPhillips told OTW that Spineology was founded in 1996 by Dr. Stephen Kuslich. Dr. Kuslich was a pioneer in minimally invasive spine surgery and was instrumental in the development of numerous spinal implants, including the BAK spine cage (co-invented with Dr. George Bagby of the Mayo Clinic in Rochester, Minnesota) and Spineologys flagship product, OptiMesh. According to company officials, the firm focuses on surgical techniques that conserve spinal bone, ligament and muscle tissue while increasing procedural efficiency. The products reduce the invasiveness of spine surgery for patients, aid the surgeon in overcoming the hurdles of minimally invasive surgery, and try to minimize the burden of healthcare expense. BY (October 28, 2011)
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Spineology/Morguefile/RRY Photo Creation
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K2M Launches RAVINE, ALEUTIAN Systems
ew Tool Alert! K2M, Inc. has launched the RAVINE Lateral Access System along with the ALEUTIAN Lateral Interbody System at the 2011 Society for Minimally Invasive Spine Surgery (SMISS) Annual Meeting in Las Vegas. RAVINE provides a dual flat blade platform for a less invasive muscle splitting transpsoas approach. The system offers rigid fixation to the spine and the versatility of both a third and fourth blade intraoperative option. It represents an innovative design departure from the tubular retractors, while providing tremendous adaptability to both patient anatomy and surgeon technique. In the October 20, 2011 news release, Dr. Pierce Nunley, an orthopedic surgeon at The Spine Institute of Louisiana, stated, The RAVINE retractor provides an innovative anatomical deployment and retraction that was designed from the outset to be a transpsoas retractor. This decreases the retraction of tissue, while providing the surgeon with secure access to the disc space. Following our initial debut of RAVINE at the
2010 NASS, we conducted global training and infrastructure expansion to execute the global launch, added Eric Major, K2Ms President and CEO. This next generation product reaffirms our commitment to being a pioneer in the global spine market and a leader in the minimally invasive market. Major told OTW, In my opinion, there are three things that make the RAVINE
Retractor a best in class product: Access - Less tissue disruption for access to the spine; Fixation - Fixation to the spine allowing for predictable stability during the procedure; Visualization - Excellent visualization of the spine during the surgery. EH (October 27, 2011)
K2M, Inc.
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Orthopedics This Week | RRY Publications LLC

Main Contact Information: RRY Publications LLC 116 Ivywood Lane Wayne, PA 19087 TOLL FREE: 1-888-749-2153 Fax: 610-260-6451
Robin R. Young, CFA Editor and Publisher robin@ryortho.com Elizabeth Hofheinz, M.P.H., M.Ed. Senior Writer elizabeth@ryortho.com Walter Eisner Senior Writer walter@ryortho.com Tom Bishow Vice President of Sales tom@ryortho.com Biloine W. Young Writer bgwy@msn.com Suzanne Kirchner Production Manager suzanne@ryortho.com Jayme Johnson Production Coordinator jayme@ryortho.com Dana Bader Graphic Designer dana@ryortho.com
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VOLUME 7, ISSUE 35 | NOVEMBER 8, 2011

Spine Fusion Reimbursement: Science or Politics? A recent study reviewed medi-

Orthopaedic Crossfire Tackles Metal on Metal A Current Concepts in

For all news that is ortho, read on.

VOLUME 7, ISSUE 35 | NOVEMBER 8, 2011

Robin Youngs Entirely Subjective Ordering of Public Orthopedic Companies

30-Day Price Change

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Robin Youngs Orthopedic Universe

Lowest Price / Earnings Ratio (TTM)

Highest Price / Earnings Ratio (TTM)

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VOLUME 7, ISSUE 35 | NOVEMBER 8, 2011

The Top Ten Best New Spine Technologies for 2011

VOLUME 7, ISSUE 35 | NOVEMBER 8, 2011

Ranier Technology Ltd. Thompson MIS

AccuLIF Expandable Interbody Fusion Cage

AlloStem Stem Cell Bone Growth Substitute

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Ti 6AI-4V ELI centerless ground rod

Hydrolift Vertebral Body Replacement System

VOLUME 7, ISSUE 35 | NOVEMBER 8, 2011

MAGEC External Remote Controller (ERC)

MAGEC Dual Rods

Nociscan Virtual Discogram

James Peacock-CEO, Nocimed, LLC

VOLUME 7, ISSUE 35 | NOVEMBER 8, 2011

PROW FUSION Intervertebral Body Fusion Device

SMISS Prospective Data Registry

VOLUME 7, ISSUE 35 | NOVEMBER 8, 2011

Spine Fusion Reimbursement: Science or Politics?

Photo Creation by RRY Publications/Morguefile

VOLUME 7, ISSUE 35 | NOVEMBER 8, 2011

Doctors Gunnar Andersson and Chris Bono (left to right)

VOLUME 7, ISSUE 35 | NOVEMBER 8, 2011

VOLUME 7, ISSUE 35 | NOVEMBER 8, 2011

VOLUME 7, ISSUE 35 | NOVEMBER 8, 2011

Orthopaedic Crossfire Tackles Metal on Metal

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Satisfy your need for speed.

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VOLUME 7, ISSUE 35 | NOVEMBER 8, 2011

Register Early and Save

7th Annual Stem Cell Summit

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VOLUME 7, ISSUE 35 | NOVEMBER 8, 2011

Sales ($ in millions) $118.1 $39.0

% Change down 2.9% down 2.3%

VOLUME 7, ISSUE 35 | NOVEMBER 8, 2011

NuVasive Headquarters/NuVasive, Inc.