Request. product overview. Value Analysis Brief. Clinical Information. 510(k) ForceTriad TM. Energy Platform

Transcription

1 Request Letter product overview Value Analysis Brief Clinical Information 510(k) ForceTriad TM Energy Platform

2 I am requesting that the ForceTriad TM energy platform be implemented in our facility so that I may have consistent access for my cases. The ForceTriad TM energy platform is a full-featured electrosurgical system that provides electrosurgical cutting and coagulation, bipolar functionality, and vessel sealing in a single generator. The ForceTriad TM energy platform is intended for open and laparoscopic surgical procedures and includes: TissueFect TM sensing technology across all modalities Valleylab TM mode for electrosurgery LigaSure TM fusion technology for vessel sealing The ForceTriad TM energy platform is the industry s only full-featured energy platform with remote software upgrade capabilities. Using the Valleylab TM Exchange Software Update System, the ForceTriad TM energy platform can be easily updated on site, providing surgeons, nurses and patients with up-to-date, state-ofthe-art technology. The ForceTriad TM energy platform delivers ground-breaking LigaSure TM tissue fusion technology for vessel sealing. LigaSure TM technology seals vessels up to and including 7 mm, lymphatics, pulmonary vasculature and tissue bundles in 2 to 4 seconds on average when using the ForceTriad TM energy platform. The ForceTriad TM energy platform provides the operating room with one energy platform meeting your electrosurgical and tissue fusion needs. Specialties utilizing the ForceTriad TM 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,

3 Product Overview ForceTriad TM Energy Platform Overview The ForceTriad TM energy platform combines monopolar electrosurgery, bi-polar electrosurgery and 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 TM devices. Specialties Colorectal Urology Orthopedics General Surgery Plastics Gynecology Order Information Catalog Number Description Order Quantity ForceTriad TM ForceTriad TM energy platform 1 each FT900 ForceTriad TM cart 1 each FT950 ForceTriad TM cart front panel 1 each FT990 ForceTraid TM cart drawer 1 each Features TissueFect TM sensing technology Valleylab TM mode for electrosurgery Enhanced LigaSure TM tissue fusion for vessel sealing Closed-loop monopolar control Built-in ammeter Automatic instrument recognition Touch screen technology Valleylab TM Exchange Software Update System Electrosurgical connectivity/compatibility with da Vinci Surgical System Autobipolar capability PER of 98 in Cut Connects with RapidVac TM smoke evacuator Adaptive REM TM system

4 Clinical Information TissueFect TM Sensing Technology TissueFect TM sensing technology is the operating system that powers all the ForceTriad TM 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 TM Mode for Electrosurgery As a true intermediary mode, the Valleylab TM 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 Valleylab TM mode is a superior choice for all applications where more control is needed for maintaining hemostasis while dividing tissues. 1 LigaSure TM Vessel Sealing Compared to mechanical ligation techniques, LigaSure TM technology has been shown to: Significantly reduce operative blood loss in colorectal, gynecologic and urologic surgery 2-5,7 Significantly reduce perioperative blood transfusions in gynecologic, urologic and general surgery 6,8,9 Significantly reduce procedure time in colorectal, gynecologic and urologic surgery 2,4,5,7,10,11 Compared to other energy-based modalities, LigaSure TM technology has been shown to: Significantly reduce operative blood loss in colorectal and gynecologic surgery 12,13,15 Significantly reduce procedure time in colorectal and gynecologic surgery 12,15 Compared to previous versions of LigaSure TM technology, the ForceTriad TM energy platform has been shown to: Provide a quicker seal, no tissue fusion failures, less bleeding and less thermal spread 16 References 1. Craig J. Valleylab TM 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 computercontrolled electrosurgery and ultrasonic dissection. Operative outcome and costs analysis. Surg Innov. 2005;12(4): 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):CR Ding Z, et al. Use of Ligasure bipolar diathermy system in vaginal hysterectomy. J Obstet Gynaecol. 2005;25(1): Levy B, Emery L. Randomized trial of suture versus electrosurgical bipolar vessel sealing in vaginal hysterectomy. Obstet Gynecol. 2003;102(1): Tamussino K, et al. Electrosurgical bipolar vessel sealing for radical abdominal hysterectomy. Gynecol Oncol. 2005;96(2): Leonardo C, et al. Laparoscopic nephrectomy using Ligasure system: preliminary experience. J Endourol. 2005;19(8): Daskalopoulos G, et al. Electrothermal bipolar coagulation for radical prostatectomies and cystectomies: a preliminary case-controlled study. Int Urol Nephrol. 2004;36(2): Romano F, et al. Laparoscopic splenectomy: ligasure versus EndoGIA: a comparative study. J Laparoendosc Adv Surg Tech. 2007;17(6): Cronjé HS, et al. Electrosurgical bipolar vessel sealing during vaginal hysterectomy. Int J Gynaecol Obstet. 2005;91(3): Metzelder ML, et al. LigaSure in laparoscopic transperitoneal heminephroureterectomy in children: a comparative study. J Laparoendosc Adv Surg Tech. 2006;16(5): Araki Y, et al. Clipless hand-assisted laparoscopic total colectomy using Ligasure Atlas. Kurume Med J. 2004;51(2): Campagnacci R, et al. Electrothermal bipolar vessel sealing device vs. ultrasonic coagulating shears in laparoscopic colectomies: a comparative study. Surg Endosc. 2007;21(9): Takada M, et al. Comparative study of electrothermal bipolar vessel sealer and ultrasonic coagulating shears in laparoscopic colectomy. Surg Endosc. 2005;19(2): 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): 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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10 COVIDIEN, COVIDIEN with logo, Covidien logo and marked brands are U.S. and/or internationally registered trademarks of Covidien AG Covidien. All rights reserved Covidien. All rights reserved. R Rev. 2010/ Longbow Drive Boulder, CO [t] [us]