Value Analysis Brief. LigaSure Advance TM Pistol Grip. Request. product overview. Cross- Reference. 510(k) Clinical Information

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1 Request Letter product overview Value Analysis Brief Clinical Information Cross- Reference 510(k) LigaSure Advance TM Pistol Grip COVIDIEN, COVIDIEN with logo, Covidien logo and positive results for life are U.S. and/or internationally registered trademarks of Covidien AG. Other marked brands are trademarks of a Covidien company Covidien. All rights reserved. R Rev. 2010/ Longbow Drive Boulder, CO [t] [us]

2 I am requesting the LigaSure Advance TM pistol grip 5 mm instrument be stocked in our facility so that I have consistent access to this device for my cases. The LigaSure Advance TM pistol grip 5 mm instrument: Contains a monopolar dissecting electrode with Valleylab TM mode for fast dissection, creating windows, enterotomies, and gastrotomies May reduce the need for instrument exchanges, thus allowing surgeons to focus on the procedure and patient Features a curved jaw for visibility of dissecting electrode LigaSure TM technology seals vessels, up to and including 7 mm, lymphatics, pulmonary vasculature* and tissue bundles in 2 to 4 seconds on average using the energy platform. LigaSure TM instruments have been found to: Have the highest burst pressure and fastest sealing time and were highest rated overall compared to Gyrus PKS TM *, Harmonic ACE * and EnSeal * 1 Reduce blood loss compared to sutures 2,3 Reduce procedure time compared to sutures 2,3 Reduce patient length of stay compared to sutures 2 Reduce mean cost per case compared to staples and clips 4 More than 200 studies have been published about LigaSure TM technology in peer-reviewed journals. I am confident using a technology backed by such a significant body of evidence-based research. Thank you for reviewing this information. Please feel free to contact me if you have any questions. Sincerely, Additional Comments: 1. Lamberton GR, Hsi RS, Jin DH, Lindler TU, Jellison FC, Baldwin DD. Prospective comparison of four laparoscopic vessel ligation devices. J Endourol. 2008;22(10): Ding Z, Wable G, Rane A. 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 Gyne col. 2003; 102(1): Marcello PW, et al. Vascular pedicle ligation techniques during laparoscopic colectomy: a prospective randomized trial. Surg Endosc. 2006;20(2): *Only when using the energy platform COVIDIEN, COVIDIEN with logo, Covidien logo and positive results for life are U.S. and/or internationally registered trademarks of Covidien AG. EnSeal * and Harmonic ACE * are trademarks of Endo-Surgery, Inc. Gyrus PKS TM * is a trademark of Gyrus ACMI. Other marked brands are trademarks of a Covidien company Covidien. All rights reserved. R Rev. 2010/ Longbow Drive Boulder, CO [t] [us]

3 Product Overview LigaSure Advance TM Pistol Grip Overview The LigaSure Advance TM pistol grip 5 mm instrument is a multifunctional instrument for laparoscopic surgical procedures requiring monopolar dissection through tissue planes, creation of otomies (i.e. enterotomy or gastrotomy) and/or sealing of vessels, tissue bundles, lymphatics and pulmonary vasculature. In addition to sealing vessels up to and including 7 mm, the LigaSure Advance TM pistol grip instrument has the added benefit of a dissecting electrode that utilizes Valleylab TM mode; a proprietary energy wave form. The LigaSure Advance TM pistol grip 5 mm instrument is intended for use ONLY with the energy platform. Specialties Colorectal Gynecology Urology General Surgery Order Information Ordering code: LF5544 Ordering quantity: 6 units/case Specifications Sterile, single use Shaft length: 44 cm Shaft diameter: 5 mm Shaft rotation: 340 degrees Jaw angle: curved Seal width: 2 mm - 3 mm Monopolar electrode length: 1 mm Cut length: approx mm Jaw length: 18 mm The Ligasure Advance TM pistol grip 5 mm instrument is only compatible with the energy platform. COVIDIEN, COVIDIEN with logo, Covidien logo and positive results for life are U.S. and/or internationally registered trademarks of Covidien AG. Other marked brands are trademarks of a Covidien company Covidien. All rights reserved. R Rev. 2010/ Longbow Drive Boulder, CO [t] [us]

4 Clinical Information Compared to mechanical ligation techniques, LigaSure TM technology has been shown to: Significantly reduce operating time and blood loss in urologic surgery 1 Significantly reduce procedure time in colorectal surgery 2, 3 Significantly reduce mean cost per case and ligation failures 4 Significantly reduce perioperative blood transfusions in general and gynecologic surgery 5, 6 Significantly reduce procedure time and length of hospital stay in gynecologic surgery 7 Compared to other energy-based modalities, LigaSure TM technology has been shown to: 8, 9, 10, 11 Significantly reduce operative blood loss in colorectal, general and gynecological surgery 8, 10, 11 Significantly reduce procedure time in colorectal, general and gynecological surgery References 1. Leonardo C, et al. Laparoscopic nephrectomy using Ligasure system: preliminary experience. J Endourol. 2005;19(8): Manasia P, et al. Ligasure versus sutures in bladder replacement with Montie ileal neobladder after radical cystectomy. Arch Ital Urol Androl. 2003;75(4): Manouras A, Filippakis GM, Tsekouras D, 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 Marcello PW, et al. Vascular pedicle ligation techniques during laparoscopic colectomy: a prospective randomized trial. Surg Endosc. 2006;20(2): Romano F, Gelmini R, Caprotti R, et al. Laparoscopic splenectomy: ligasure versus EndolGIA: a comparative study. J Laparoendosc Adv Surg Tech. 2007;17(6): Tamussino K, et al. Electrosurgical bipolar vessel sealing for radical abdominal hysterectomy. Gynecologic Oncology. 2004;96(82): Ding Z, Wable G, Rane A. Use of Ligasure bipolar diathermy system in vaginal hysterectomy. J Obstet Gynaecol. 2005;2591): Guerrieri M, et al. Use of the electrothermal bipolar vessel system (EBVS) in laparoscopic adrenalectomy: a prospective study. Surg Endosc Jan;22(1): Note: Left adrenalectomy (72.2 vs. 94 mins, p=0.023) right adrenalectomy (51.8 vs.68.6 mins, NS) 9. Campagnacci R, et al. Electrothermal bipolar vessel sealing device vs. ultrasonic coagulating shears in laparoscopic colectomies: a comparative study. Surg Endosc. 2007;21(9): Demirtuk F, Aytan H, Caliskan AC. Comparison of the use of electrothermal bipolar vessel sealer with harmonic scapel in total laparoscopic hysterectomy. J Obstet Gynaecol Res. 2007;33(3): Araki Y, Noake T, Kanazawa M, et al. Clipless hand-assisted laparoscopic total colectomy using Ligasure Atlas. Kurume Med J. 2004;51(2): COVIDIEN, COVIDIEN with logo, Covidien logo and positive results for life are U.S. and/or internationally registered trademarks of Covidien AG. Other marked brands are trademarks of a Covidien company Covidien. All rights reserved. R Rev. 2010/ Longbow Drive Boulder, CO [t] [us]

5 Cross-REference Vendor Catalog # Description Diameter Shaft Length Hand Switching Sealing Independent of Cutting Description Covidien Covidien LF5544 LS1500 LigaSure Advance TM pistol grip laparoscopic instrument LigaSure TM 5 mm dolphin tip 5 mm 44 cm Yes Yes The multifunctional LigaSure Advance TM pistol grip 5 mm instrument can potentially replace a combination of the following devices within these areas: Vessel Sealing Devices 1 5mm 37 cm Yes Yes Covidien LS1037 LigaSure Atlas TM 10 mm 10 mm 37 cm Yes Yes Covidien LF1537 LigaSure TM 5 mm blunt tip 5 mm 37 cm Yes Yes NSEAL-335H NSEAL-345H NSEAL-535H EnSeal * TRIO device, curved round tip EnSeal * TRIO device, curved round tip EnSeal * device standard tip 5 mm 35 cm Yes Yes EnSeal * 5 mm 45 cm Yes Yes EnSeal * 5 mm 35 cm Yes Yes EnSeal * NSEAL-525RH EnSeal * round tip 5 mm 25 cm Yes Yes EnSeal * NSEAL-535RH EnSeal * round tip 5 mm 35 cm Yes Yes EnSeal * NSEAL-545RH EnSeal * round tip 5 mm 45 cm Yes Yes EnSeal * ETRIO-525H ETRIO-545H Other Energy-Based Devices 2 EnSeal * device standard tip EnSeal * device standard tip 5 mm 25 cm Yes Yes EnSeal * 5 mm 45 cm Yes Yes EnSeal * ACE36E ACE36P ACE45E LCSC5HA LCSC5L Harmonic ACE * with ergonomic grip Harmonic ACE * with pistol curved handle Harmonic ACE * Curved Shears Harmonic Scalpel * Hand Controlled Curved Shears Harmonic Scalpel * long 5 mm Curved Shears, pistol grip 5 mm 36 cm Yes No 5 mm 36 cm Yes No 5 mm 45 cm Yes No 5 mm 36 cm Yes No 5 mm 45 cm Yes No Harmonic * Harmonic * Harmonic * Harmonic * Harmonic * 1. Vessel sealing instruments are indicated for sealing vessels up to and including 7 mm vessels. 2. Energy-based instruments are used predominantly for dissection to include ultrasonic, radio frequency (RF), light, thermal, hydromechanical, cryogenic and microwave technologies.

6 Cross-REference Vendor Catalog # Description Diameter Shaft Length Hand Switching Sealing Independent of Cutting Description Covidien LCSK5 Harmonic * LCS, pistol grip 5 mm 36 cm Yes No Harmonic * Olympus/Gyrus CUT/FCP 5 mm 33 cm No No Gyrus Olympus/Gyrus CUT/FCP 5 mm 33 cm No No Gyrus Olympus/Gyrus 3005PK3 CUT/FCP 5 mm 33 cm No No Gyrus Olympus/Gyrus PK PKS TM * CUT/FCP 5 mm 24 cm No No Gyrus Olympus/Gyrus PK PKS TM * CUT/FCP 5 mm 33 cm No No Gyrus Olympus/Gyrus PK PKS TM * CUT/FCP 5 mm 45 cm No No Gyrus Olympus/Gyrus COAG TM * Bipolar Laparoscopy Probes 5 mm 32 cm N/A N/A Gyrus Olympus/Gyrus L-Hook w/sheath 5mm 33 cm N/A N/A Gyrus Olympus/Gyrus PC Plasma J-Hook 5 mm 24 cm N/A N/A Gyrus Olympus/Gyrus PC Plasma J-Hook 5 mm 45 cm N/A N/A Gyrus Olympus/Gyrus Olympus/Gyrus LF PK PK PKS TM * Plasma Spatula w/ cord PKS TM * Plasma Spatula w/ cord 5 mm 33 cm N/A N/A Gyrus 5 mm 45 cm N/A N/A Gyrus Olympus/Gyrus 3527PK L-Hook w/sheath 5 mm 33 cm N/A N/A Gyrus Olympus/Gyrus PK PKS TM * L-Hook, 9-pin 5 mm 33 cm N/A N/A Gyrus Covidien FT3000 Force TriVerse TM 5 mm N/A Yes N/A Covidien E Covidien E Covidien E LigaSure Advance TM pistol grip laparoscopic instrument larascopic electrode, straight spatula tip larascopic electrode, curved spatula tip larascopic electrode, curved spatula tip 5 mm 44 cm Yes Yes The multifunctional LigaSure Advance TM pistol grip 5 mm instrument can potentially replace a combination of the following devices within these areas: Other Energy-Based Devices 2 (continued) 4.8 mm 36 cm N/A N/A 4.8 mm 36 cm N/A N/A 4.8 mm 45 cm N/A N/A 2. Energy-based instruments are used predominantly for dissection to include ultrasonic, radio frequency (RF), light, thermal, hydromechanical, cryogenic and microwave technologies.

7 Cross-REference Vendor Catalog # Description Diameter Shaft Length Hand Switching Sealing Independent of Cutting Description Covidien LF5544 LigaSure Advance TM pistol grip laparoscopic instrument 5 mm 44 cm Yes Yes The multifunctional LigaSure Advance TM pistol grip 5 mm instrument can potentially replace a combination of the following devices within these areas: Other Energy-Based Devices 2 (continued) Covidien E larascopic electrode, wire J-hook tip 4.8 mm 36 cm N/A N/A Covidien E larascopic electrode, wire L-hook tip 4.8 mm 36 cm N/A N/A Covidien E larascopic electrode, wire L-hook tip 4.8 mm 45 cm N/A N/A Covidien E larascopic electrode, flat L-hook tip 4.8 mm 36 cm N/A N/A Endo-Mechanical Devices 3 Various Manufacturers Clip appliers N/A N/A N/A N/A N/A Various Manufacturers Stapler N/A N/A N/A N/A N/A Various Manufacturers Staple reloads N/A N/A N/A N/A N/A Covidien Endo Dissect TM 5 mm 31 cm N/A N/A N/A Covidien Endo Clinch TM II 5 mm 31 cm N/A N/A N/A Covidien Endo Shears TM 5 mm 31 cm N/A N/A N/A Covidien Endo Shears TM Long 5 mm 45 cm N/A N/A N/A 2. Energy-based instruments are used predominantly for dissection to include ultrasonic, radio frequency (RF), light, thermal, hydromechanical, cryogenic and microwave technologies. 3. Endo-mechanical instruments can be used for dissection, manipulation of tissue and/or ligation. *Covidien Autosuture brand. COVIDIEN, COVIDIEN with logo, Covidien logo and positive results for life are U.S. and/or internationally registered trademarks of Covidien AG. Harmonic *, EnSeal *, Harmonic Scalpel * and Harmonic ACE * are trademarks of Endo-Surgery, Inc. Gyrus TM *, COAG TM * and Gyrus PKS TM * are trademarks of Gyrus ACMI. Other marked brands are trademarks of a Covidien company Covidien. All rights reserved. R Rev. 2010/ Longbow Drive Boulder, CO [t] [us]

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12 2010 Covidien. All rights reserved. R Rev. 2010/ Longbow Drive Boulder, CO [t] [us]