Request

Letter

product
overview

Value Analysis Brief Clinical

Information

510(k)

ForceTriad Energy Platform

TM
I am requesting that the ForceTriad energy platform be implemented in our facility so that I may have
TM

consistent access for my cases.

The ForceTriad energy platform is a full-featured electrosurgical system that provides electrosurgical cutting
TM

and coagulation, bipolar functionality, and vessel sealing in a single generator. The ForceTriad energy
TM

platform is intended for open and laparoscopic surgical procedures and includes:

• TissueFect sensing technology across all modalities

TM

• Valleylab mode for electrosurgery

TM

• LigaSure fusion technology for vessel sealing

TM

The ForceTriad energy platform is the industry’s only full-featured energy platform with remote software
TM

upgrade capabilities. Using the Valleylab Exchange Software Update System, the ForceTriad energy
TM TM

platform can be easily updated on site, providing surgeons, nurses and patients with up-to-date, state-of-
the-art technology.

The ForceTriad energy platform delivers ground-breaking LigaSure tissue fusion technology for vessel
TM TM

sealing. LigaSure technology seals vessels up to and including 7 mm, lymphatics, pulmonary vasculature and
TM

tissue bundles in 2 to 4 seconds on average when using the ForceTriad energy platform.
TM

The ForceTriad energy platform provides the operating room with one energy platform meeting your
TM

electrosurgical and tissue fusion needs. Specialties utilizing the ForceTriadTM energy platform include:

Colorectal Urology Orthopedics

General Surgery Plastics Gynecology

Thank you for reviewing this information. Please feel free to contact me if you have any questions.

Sincerely,
 Product Overview

ForceTriadTM Energy Platform

Overview
The ForceTriad energy platform combines monopolar electrosurgery, bi-polar electrosurgery and
TM

vessel sealing in a single generator intended for open and laparoscopic surgical procedures. This
all-in-one generator is compatible with conventional electrosurgical instruments as well as all
current LigaSure devices.
TM

Specialties
Colorectal Urology Orthopedics
General Surgery Plastics Gynecology

Order Information
Catalog Number Description Order Quantity
ForceTriad TM
ForceTriad energy platform
TM
1 each
FT900 ForceTriad cart
TM
1 each
FT950 ForceTriad cart front panel
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1 each
FT990 ForceTraid cart drawer
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1 each

Features
TissueFect sensing technology
TM

Valleylab mode for electrosurgery

TM

Enhanced LigaSure tissue fusion for vessel sealing

TM

Closed-loop monopolar control

Built-in ammeter
Automatic instrument recognition
Touch screen technology
Valleylab Exchange Software Update System
TM

Electrosurgical connectivity/compatibility with da Vinci® Surgical System

Autobipolar capability
PER of 98 in Cut
Connects with RapidVac smoke evacuator
TM

Adaptive REM system

TM
 Clinical Information

TissueFect Sensing Technology

TM

TissueFectTM sensing technology is the operating system that powers all the ForceTriadTM energy platform functions and
is designed to precisely manage energy delivery, creating a range of options for improved desired tissue effect and
consistent power delivery.
Valleylab Mode for Electrosurgery
TM

“As a true intermediary mode, the ValleylabTM mode divides tissue efficiently while maintaining hemostasis and
minimizing thermal injury to surrounding tissues. This mode minimizes the disadvantages of the Cut and Fulgurate
modes while maximizing control. The ValleylabTM mode is a superior choice for all applications where more control is
needed for maintaining hemostasis while dividing tissues.”1
LigaSure Vessel Sealing
TM

Compared to mechanical ligation techniques, LigaSure technology has been shown to: TM

Significantly reduce operative blood loss in colorectal, gynecologic and urologic surgery2-5,7
Significantly reduce perioperative blood transfusions in gynecologic, urologic and general surgery6,8,9
Significantly reduce procedure time in colorectal, gynecologic and urologic surgery2,4,5,7,10,11

Compared to other energy-based modalities, LigaSure technology has been shown to: TM

Significantly reduce operative blood loss in colorectal and gynecologic surgery12,13,15

Significantly reduce procedure time in colorectal and gynecologic surgery12,15

Compared to previous versions of LigaSure technology, the ForceTriad energyTM TM

platform has been shown to:

Provide a quicker seal, no tissue–fusion failures, less bleeding and less thermal spread16

References
1. Craig J. ValleylabTM Mode: A Comparison with Conventional Electrosurgery. White paper on file at Covidien, Boulder, Colo.
2. Targarona EM, et al. Energy sources for laparoscopic colectomy: a prospective randomized comparison of conventional electrosurgery, bipolar computer-
controlled electrosurgery and ultrasonic dissection. Operative outcome and costs analysis. Surg Innov. 2005;12(4):339-344.
3. Manouras A, et al. Sutureless open low anterior resection with total mesorectal excision for rectal cancer with the use of the electrothermal bipolar vessel
sealing system. Med Sci Monit. 2007;13(5):CR224-230.
4. Ding Z, et al. Use of Ligasure bipolar diathermy system in vaginal hysterectomy. J Obstet Gynaecol. 2005;25(1):49-51.
5. Levy B, Emery L. Randomized trial of suture versus electrosurgical bipolar vessel sealing in vaginal hysterectomy. Obstet Gynecol. 2003;102(1):147-151.
6. Tamussino K, et al. Electrosurgical bipolar vessel sealing for radical abdominal hysterectomy. Gynecol Oncol. 2005;96(2):320-322.
7. Leonardo C, et al. Laparoscopic nephrectomy using Ligasure system: preliminary experience. J Endourol. 2005;19(8):976-978.
8. Daskalopoulos G, et al. Electrothermal bipolar coagulation for radical prostatectomies and cystectomies: a preliminary case-controlled study.
Int Urol Nephrol. 2004;36(2):181-185.
9. Romano F, et al. Laparoscopic splenectomy: ligasure versus EndoGIA: a comparative study. J Laparoendosc Adv Surg Tech. 2007;17(6):763-767.
10. Cronjé HS, et al. Electrosurgical bipolar vessel sealing during vaginal hysterectomy. Int J Gynaecol Obstet. 2005;91(3):243-245.
11. Metzelder ML, et al. LigaSure in laparoscopic transperitoneal heminephroureterectomy in children: a comparative study. J Laparoendosc Adv Surg Tech.
2006;16(5):522-525.
12. Araki Y, et al. Clipless hand-assisted laparoscopic total colectomy using Ligasure Atlas. Kurume Med J. 2004;51(2):105-108.
13. Campagnacci R, et al. Electrothermal bipolar vessel sealing device vs. ultrasonic coagulating shears in laparoscopic colectomies: a comparative study.
Surg Endosc. 2007;21(9):1526-1531.
14. Takada M, et al. Comparative study of electrothermal bipolar vessel sealer and ultrasonic coagulating shears in laparoscopic colectomy. Surg Endosc.
2005;19(2):226-228.
15. Demirturk F, et al. Comparison of the use of electrothermal bipolar vessel sealer with harmonic scalpel in total laparoscopic hysterectomy.
J Obstet Gynaecol Res. 2007;33(3):341-345.
16. Ponsky T, et al. Experience with a new energy source for tissue fusion in pediatric patients. J Laparoendosc Adv Surg Tech. 2009;1 (suppl): 207 S -209S.
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