Romeo2 Mislight Presentation 0612e

R O M E O®2 MIS
CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

M.I.S. SURGERY
H I S TO R I C A L C O N T E X T & E VO LU T I O N O F M . I . S . S U R G E RY

M.I.S. SURGERY HISTORICAL CONTEXT
1982
Transforaminal Lumbar Interbody Fusion
Harms
Percutaneous Pedicle Screw Placement
Magerl 1998
Lateral Transpsoas Approach – DLIF, XLIF
McAffee & Pimenta
1987
Vertebroplasty
Galibert
1995
2000
M.I.S. ALIF
Mathews & Zucherman Kyphoplasty
Wong
Oppenheimer et. al. “Minimally invasive spine technology and minimally invasive spine surgery: a historical review” / Neurosurgical Focus 2009

M.I.S. SURGERY HISTORICAL CONTEXT
2001
Sextant Percutaneous Pedicle Screw System
Foley
2003
Tubular Discectomy using Microscope MetrX
Foley
2006
M.I.S. TLIF 2011 (np)
Holly M.I.S. K Wireless
Mangione
2002 2004
M.I.S PLIF Transaxial Approach

Khoo Cragg
M.I.S. Lumbar Laminectomy for Stenosis

Guilot, Khoo, Palmer
Oppenheimer et. al. “Minimally invasive spine technology and minimally invasive spine surgery: a historical review” / Neurosurgical Focus 2009

M.I.S. SURGERY EVOLUTION
Standard
midline
Posterior lumbar fixation Bilat. Wiltse
Percutaneous
ALIF XLIF / OLIF
Interbody fusion TLIF
PLIF AxiaLIF

M.I.S. SURGERY EVOLUTION
Traditional open spine

surgery for lumbar
fusion procedures
Minimally invasive spine

surgery for lumbar
fusion procedures

M.I.S. SURGERY
M A R K E T OV E RV I E W

M.I.S. SURGERY MARKET OVERVIEW
It is estimated that 85% of all thoracolumbar instrumented procedures in ROW are

performed through the traditional open approach and only 15% minimally invasive
(US 75% vs. 25%)
MIS techniques are however gaining ground over traditional open procedures and are
estimated to make 30% - 40% of all thoracolumbar instrumented procedures
(fixation and interbody fusion) until 2013
3 column stabilization using a traditional standard midline approach for the spondylodesis
and the interbody fusion today are still the gold standard in lumbar spine surgery
Millenium Research Group EU Report 2009

M.I.S. SURGERY MARKET OVERVIEW
The M.I.S. spinal implant market 2011

7%
3%
15%
60%
12%
M.I.S. TL fixation TLIF / OLIF PLIF ALIF M.I.S. approach sys.

M.I.S. TL fixation devices remain the cash cow, while TLIF/OLIF implants cannibalize the PLIF implant
sector
M.I.S. approach systems (retractors, ports) push sales on both sides: M.I.S. TL fixation and M.I.S.
interbody fusion
Millenium Research Group EU Report 2009

Source: MIS Spine Millenium Report, 2004
ROMEO® 2 MIS
L EG I T I M I TAT I O N & D E M A N D S

ROMEO®2 MIS L E G I T I M I TAT I O N & D E M A N D S


SURGEON
M.I.S. “one-stop-shop” system
Reduction of x-rays
Multiple approach possibilities
Included M.I.S. retractor system
Spondylolisthesis reduction capability
M.I.S. intersomatic fusion solutions
Procedural efficiency (scientific aspect)
Reproducibility of clinical outcomes (scientific aspect)


SCRUB NURSE
Intuitive instruments
Less instruments and less containers in the OR
Low learning curve
Logical tray set-up
Colour coded, sterile packed and traceable implants
Attractive design


HOSPITAL ADMINISTRATION
Price sensitive M.I.S. system (less disposables)
Low stocking costs
Low sterilization costs
Low maintenance costs
Procedural efficiency (clinical marketing aspect)
Reproducibility of clinical outcomes (clinical marketing aspect)

ROMEO® 2 MIS
CONCEPT & DESIGN

ROMEO®2 MIS CONCEPT & DESIGN
Ø5mm yellow coded and cannulated polyaxial pedicle screws

from 30mm – 50mm length (5mm increments).
Ø6mm and Ø7mm yellow coded and cannulated polyaxial pedicle

screws from 30mm – 60mm length (5mm increments).
Universal setscrews with a Ø4mm inner hexagonal key closing at a

predefined 12Nm torque.
Straight and pre-bent percutaneous rods from 30mm to 200mm.
All rods come in 5mm increments from 30mm to 90mm and in

20mm increments from 100mm to 200mm.
All percutaneous rods up to 200mm length are sterile packed as

double units.
All implants are made of a titanium alloy (TA6V4) , biocompatible

according to ISO 5832.3.

ROMEO®2 MIS CONCEPT & DESIGN

ROMEO®2 MIS C O N C E P T & D E S I G N – C O M PA C T S E T
No. APPROACH RACK: MIS-BX 10 02-N
A trocar 3 in 1
square awl / dilator tube #1
needle
A
t-handle (radel)
A
B trocar 3 in 1 / stick
C B
C K wire impactor
D
D dilator tube # 2 A
E
E dilator tube # 3
F H
F dilator tube # 4
I
G dilator tube # 5 G
H dilator tube # 4 / serrated According to 2011 instrument repartition ROMEO®2 MIS - ROW
I pedicle probe (K wireless)

ROMEO®2 MIS C O N C E P T & D E S I G N – C O M PA C T S E T
No. SCREW INSERTION CONTAINER: MIS-BX 10 01-N
J straight handle ratchet

K screwdriver shaft PS can.
L screwdriver tube
M clipping tube
N clipping tube open
O setscrew holder R
P universal tube J P
Q setscrew tightener L
K M
R fascia dilator Q
S K wire tube O N
K wire blunt S
K wire w/trocar tip According to 2011 instrument repartition ROMEO®2 MIS - ROW

ROMEO®2 MIS C O N C E P T & D E S I G N - C O M PA C T S E T
No. ROD MANIPULATION RACK: MIS-BX 11 02-N
A caliper
B rod inserter
C
C rod pusher
D persuader D
E locker
F stabilizer B
E
F
A
According to 2011 instrument repartition ROMEO®2 MIS - ROW

ROMEO®2 MIS C O N C E P T & D E S I G N - C O M PA C T S E T
No. FINAL TIGHTENING CONTAINER: MIS-BX 11 02-N
G rod bender
H compression forceps
I distraction forceps
G K
J t-handle ratchet
L
K t-handle
L dynamometric tightener
H I
J
According to 2011 instrument repartition ROMEO®2 MIS - ROW

ROMEO®2 MIS RETRACTOR C O N C E P T & D E S I G N – C O M PA C T S E T
No. BLADES RACK / SUPERIOR: MIS-BX 12 03-N
A blades W16mm
L40mm – 110mm
A
B blades W21mm
L40mm – L110mm
Blades from L120mm to B

L130mm are optional
According to 2011 instrument repartition ROMEO®2 MIS RETRACTOR - ROW

ROMEO®2 MIS RETRACTOR C O N C E P T & D E S I G N - C O M PA C T S E T
No. RETRACTOR SYSTEM RACK / INFERIOR: MIS-BX 12 02-N
A retractor system
B threaded tube / small A
C t-shaft / small B F
D threaded tube / large
E t-shaft / large G
C
F blade holder
G counter torque / small
H locker D
H
I blade locker
E I
According to 2011 instrument repartition ROMEO®2 MIS RETRACTOR - ROW

ROMEO®2 MIS RETRACTOR C O N C E P T & D E S I G N – C O M PA C T S E T
No. APPROACH & DISTRACTION CONTAINER: MIS-BX 12 01-N
J trocar 3 in 1
square awl / dilator tube #1
J
needle
t-handle (radel) K
K trocar 3 in 1 / stick L
P
L dilator tube #2 M
M dilator tube #3 N
O
N dilator tube #4
O dilator tube #5 Q
P distraction forceps
Q empty space for instruments According to 2011 instrument repartition ROMEO®2 MIS RETRACTOR - ROW

ROMEO® 2 MIS
F EAT U R E S & B E N E F I T S

ROMEO®2 MIS F E AT U R E S & B E N E F I T S
K WIRELESS OPTION & STREAMLINED TIP
MICRO-OPEN & PERCUTANEOUS APPROACHES
M.I.S. RETRACTOR SYSTEM
SPONDYLOLISTHESIS REDUCTION
SYNERGY WITH JULIET® CAGES
COMPACT SET


1 K WIRELESS OPTION
FEATURE
The K wireless option is designed to enable the surgeon to
reduce intra-operative x-rays and to reduce the risk of a K wire
migration while simultaneously reducing the learning curve
associated with common M.I.S. techniques.
BENEFITS
Application of the classic pedicle preparation technique.
Reduction of intra-operative x-rays and elimination of K wire
migration risks.
Straight forward pedicle screw placement technique due to
streamlined tip.

1 K WIRELESS OPTION

1 K WIRELESS OPTION

Feature: Dilator #4 / Serrated & K wireless pedicle probe

The K wireless concept was designed to avoid K wire migration
and handling complications.
Benefit: Adaptation to classic pedicle preparation technique

The surgeons have the opportunity to apply the classic pedicle
preparation technique with a modified bone probe for a
minimally invasive technique.

Feature: Straight forward screw insertion w/o K wires

The K wireless concept is designed to enable the surgeons to
reduce the surgical steps, thereby reducing x-ray exposure.
Benefit: Less operative steps & less x-ray exposure

The K wireless concept is a straight – forward pedicle screw
insertion technique, without the necessity of considering
K wire handling issues or multiple radiographic control shots.

1 STREAMLINED TIP
FEATURE
1/3rd of the screw’s distal tip is designed conical, whereas the
proximal part is designed cylindrical.
Conical “bullet-shaped” tip of the srew.
BENEFITS
Allows an adjustment of the screw trajectory in the pedicle
canal after initial insertion.
Allows for an effortless, self-centering and K wireless screw
insertion.

1 STREAMLINED TIP

The option of a K wire remains for difficult anatomies

Feature: Streamlined screw tip

The unique design of the self-centering screw allows for an
effortless and K wireless screw insertion.
Benefit: Effortless screw insertion technique

The conical tip of the screw is placed into the pedicle canal which
was preliminary prepared with the K wireless bone probe, a
modified classical bone probe for a pure M.I.S. approach.
The self-centering screw is guided into the pedicle canal and

allows for a smooth trajectory correction before gripping to the
bone.


MICRO OPEN & PERCUTANEOUS APPROACHES

2
FEATURE
Choice of bilateral micro-open, pure percutaneous or hybrid
approaches to the thoracic junction and lumbar spine.
BENEFITS
Freedom of choice and combination possibilities between 3
techniques for the rod placement.
All 3 techniques can be accomplished by using the K wireless
instrumentation.


2


2



FEATURE
3 Self-retaining M.I.S. retractor system allows for both a parallel
distraction of the vertebral bodies and atraumatic muscle
retraction in order to reach the intervertebral space.
BENEFITS
The extender/blade or pure blade retraction possibilities
enable two approach techniques.
• Auto-stable and low profile system, no table attachment
required.
• Following the concept of a cervical “CASPAR” style retractor.
• Surgical illumination system device.




FEATURES
Bilateral, progressive, powerful and accurate spondylolisthesis
reduction.
4
BENEFITS
Controlled and parallel reduction of the slipped vertebral body
up to 20mm with a special persuader that is attached to the
clipping tubes.
Double threaded mechanism in order to reduce the vertical
force applied to the instrument and the vertebral body.




FEATURE
5 Minimally invasive 3 column stabilization in combination with
transforaminal JULIET ®TL or oblique lateral JULIET ®OL
interbody fusion devices.
BENEFITS
The ROMEO®2 M.I.S. pedicle screw system, the JULIET®TL and
JULIET®OL cages in combination with the ROMEO®2 M.I.S.
RETRACTOR system offer the surgeon a one-stop-shop for a
complete treatment concept.

M.I.S. SURGERY F E AT U R E S & B E N E F I T S



COMPACT SET
6
FEATURE
Choice of multi-use instruments, designed to allow for an
intuitive handling.
Two sets for M.I.S. Procedures, one complementary set for
M.I.S. RETRACTOR.

6 2
M.I.S.
5 3
It‘s the combination of the features and benefits that make the system unique.

M.I.S. SURGERY SUMMARY
ROMEO®2 M.I.S. POSTERIOR FIXATION SYSTEM
1
Choice of bilateral micro-open, pure percutaneous or hybrid
approaches to the thoracic junction and lumbar spine.
K wireless option to enable the surgeon to reduce

intraoperative x-rays and to reduce the risk of a K wire
migration by simultaneously reducing the learning curve
associated with common M.I.S. techniques.
Bilateral, progressive, powerful and accurate spondylolisthesis

reduction capability.
Unique screw with conical tip allowing for an effortless, self-

centering and K wireless screw insertion.

ROMEO®2 M.I.S. RETRACTOR SYSTEM
2
Self-retaining M.I.S. retractor system allows for both a parallel
distraction of the vertebral bodies and atraumatic muscle
retraction in order to reach the intervertebral space.
The unique screw based retractor system allows for the most
parallel distraction of the vertebral bodies in order to perform
facetectomy, decompression and interbody device
implantation.
No need of an additional table fixation.
Retractor illumination system available.

3 Minimally invasive 3 column stabilization in combination with

transforaminal JULIET®TL or oblique lateral JULIET®OL interbody
fusion devices.
COMPACT SET
Only 3 sets for M.I.S. procedure.

ROMEO® 2 MIS
S U R G I C A L T EC H N I Q U E

ROMEO®2 MIS SURGICAL TECHNIQUE




12Nm


FINAL CONTROL

ROMEO®2 MIS SURGICAL TECHNIQUE - OPTIONS
20mm

•Installation, distraction and inclination of blades

•Parallel cranial/caudal distraction over extenders

SCREW BASED M.I.S. RETRACTOR TLIF or OLIF CAGE INSERTION

PLACEMENT
Parallel cranial/caudal distraction over extenders Please stick to the surgical technique as
to generate space for the intersomatic approach described in JULIET® TL & OL


ROMEO® 2 MIS
COMPETITION

ROMEO®2 MIS COMPETITION
Zimmer Spine Pathfinder™

Advantages Disadvantages
Easy-to- handle system Only mini-open, no percutaneous solution
Harmony retractor, port and dedicated Poor spondylolisthesis reduction capacity
approach instruments as a complement to the
Bilateral Wiltse approach as the only option
pedicle screw fixation system
Setscrew with predetermined breaking point
TraXis TLIF and ArDis Go-LIF cages for the
interbody fusion Attachment of screw towers to pedicle screws
is quite fiddling; 2 long attachment screws
Pioneering system in M.I.S. surgery (2002)
additionally needed per screw
Good documentation and sufficient
K wire obligatory
publications
Pathfinder™ NEXT (new generation) was just

launched at NASS

Zimmer Spine Pathfinder™ NXT

Choice of mini-open or percutaneous
K wire obligatory
approaches
Aras® and Harmony TM Retractor Limited experience with this new generation
Interbody spacer ranges
Silmutaneous controlled
distraction/compression and reduction

Medtronic Sofamor Danek SEXTANT™ 2

First real percutaneous system in the market No spondylolisthesis reduction capacity
Efficient for monosegmental percutaneous Limited up to 2-levels
fixation
Difficult intraoperative handling of rod when
Quadrant M.I.S. retractor system and X-tube screws are misaligned or positioned in different
incl. fiber optic lights as a complementary heights
approach system
Limited distraction/compression capacity
Different cage options (Capstone PLIF/TLIF, (maneuver is performed with screwdrivers)
Crescent TLIF, Boomerang TLIF) for the
K wire obligatory
interbody fusion
Navigation opportunity
Good further development since launch
Good documentation and sufficient
publications

Medtronic Sofamor Danek LONGITUDE™

Sequential dilation Pure percutaneous system
Multilevel, percutaneous treatment possible Intended for long constructs only; separate
system from SEXTANT™ philosophy
Combined extender/persuader tubes
K wire obligatory
Counter torque can be positioned in 360 ,
freedom of maneuvering for the surgeon
Less rigid system than SEXTANT™
Re-lordosation and kypho possible with new

system and mono screws

DePuy Spine VIPER™

Alignment guide for screw extenders Only one Ø15mm dilator (Ø14mm screw),
though risk of skin necrosis
Extenders for obese patients available
No spondylolisthesis reduction capacity
Pre-bent rods with midline markings
No sequential dilation possible
Contains all advantages of the EXPEDIUM®
system Difficult assembly of the extenders and the
pedicle screws
Different MIS retractor system and portal
systems available Very demanding rod placement
Extensive cage range Manual and uncontrolled compression
VIPER™ 2 has been launched K wire obligatory

DePuy Spine VIPER™ 2

One system for deformity, degenerative and
Limited spondylolisthesis reduction capacity
trauma indications
No sequential dilation possible
Compatibility with Depuy Spine’s EXPEDIUM
Manual compression
system
K wire obligatory
Reduction screws
Different Rod options: straight, lordosed and

kyphosed
Different Rod approximation options
PIPELINE MIS Retractor

Globus Pivot™
Spondylolisthesis reduction capacity Setscrew often cross threads in tulip of the
pedicle screw
M.I.S. rod persuader available
Very bulky system
Ø8mm rescue screws available
Only one dilator for the approach
MIS retractor system and ports available
Very complex system, though high learning
curve
K wire obligatory

K2M Serengeti™
Flexible extenders allow for good exposure Extenders are single use instruments
Multilevel treatment capacity Rod placement and reduction very difficult,
since extenders are elastic
Compression and distraction maneuvers nearly
impossible due to elastic extenders
K wire obligatory

Stryker Mantis™
Treatment capacity standardized up to 3-levels Complicated assembly of extenders and pedicle
screws (extenders have to be withhold with
System is used from 3 surgeons worldwide as a
rings)
deformity system; next level of MIS surgery in
development Counter torque handling
Lateral fusion capacity Limited spondylolisthesis reduction capacity
Easy rod placement and very good rod K wire obligatory
measurement and rod contouring option

Synthes MATRIX Spine System

Multilevel treatment capacity, for deformity, Very complex system, though high learning
degenerative and trauma indications curve
Percutaneous and mini-open No sequential dilation
approaches/techniques
Need to create pathway
Preassembled cannulated pedicle screws
Low reduction capacity
MIS Rod holder for accurate rod placement
K wire obligatory
T-PAL (Transforaminal Posterior Atraumatic
Lumbar Cage System)

Vertiflex Silverbolt™
Percutaneous screw/rod system Very complex system, though high learning
curve
Extenders can be preloaded with rod
Extenders are assembled in-situ
Bullet shaped rods
Max. 2-levels
K wire obligatory

ROMEO® 2 MIS
S I M P LY I N N OVAT I V E

Thank you very much!

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R O M E O®2 MIS

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

M.I.S PLIF Transaxial Approach

M.I.S. Lumbar Laminectomy for Stenosis

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

Posterior lumbar fixation Bilat. Wiltse

ALIF XLIF / OLIF

Interbody fusion TLIF

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

Traditional open spine

Minimally invasive spine

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

It is estimated that 85% of all thoracolumbar instrumented procedures in ROW are

Millenium Research Group EU Report 2009

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

The M.I.S. spinal implant market 2011

M.I.S. TL fixation TLIF / OLIF PLIF ALIF M.I.S. approach sys.

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

Less instruments and less containers in the OR

Low learning curve

Logical tray set-up

Colour coded, sterile packed and traceable implants

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

Low stocking costs

Low sterilization costs

Low maintenance costs

Procedural efficiency (clinical marketing aspect)

Reproducibility of clinical outcomes (clinical marketing aspect)

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

CONCEPT & DESIGN

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

Ø5mm yellow coded and cannulated polyaxial pedicle screws

Ø6mm and Ø7mm yellow coded and cannulated polyaxial pedicle

Universal setscrews with a Ø4mm inner hexagonal key closing at a

Straight and pre-bent percutaneous rods from 30mm to 200mm.

All rods come in 5mm increments from 30mm to 90mm and in

All percutaneous rods up to 200mm length are sterile packed as

All implants are made of a titanium alloy (TA6V4) , biocompatible

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

No. APPROACH RACK: MIS-BX 10 02-N

I pedicle probe (K wireless)

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

No. SCREW INSERTION CONTAINER: MIS-BX 10 01-N

J straight handle ratchet

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

No. ROD MANIPULATION RACK: MIS-BX 11 02-N

According to 2011 instrument repartition ROMEO®2 MIS - ROW

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

No. FINAL TIGHTENING CONTAINER: MIS-BX 11 02-N

According to 2011 instrument repartition ROMEO®2 MIS - ROW

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

No. BLADES RACK / SUPERIOR: MIS-BX 12 03-N

Blades from L120mm to B