Value analysis Brief - medtronic.com · I am requesting the LigaSure AdvanceTM pistol grip 5 mm instrument be stocked in our facility so that I have consistent access to this device

Value analysis Brief

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CliniCalinformation

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requestletter

Cross-referenCe

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. © 2010 Covidien. All rights reserved. R0013643 Rev. 2010/04

LigaSure AdvanceTM

Pistol Grip

5920 Longbow DriveBoulder, CO 80301

303-530-2300 [t]

800-255-8522 [us] www.covidien.com

I am requesting the LigaSure AdvanceTM pistol grip 5 mm instrument be stocked in our facility so that I have consistent access to this device for my cases.

The LigaSure AdvanceTM pistol grip 5 mm instrument:

• ContainsamonopolardissectingelectrodewithValleylabTM mode for fast dissection, creating windows,enterotomies,andgastrotomies• Mayreducetheneedforinstrumentexchanges,thusallowingsurgeonstofocusonthe procedure and patient• Featuresacurvedjawforvisibilityofdissectingelectrode

LigaSureTM technology seals vessels, up to and including 7 mm, lymphatics, pulmonary vasculature* and tissuebundlesin2to4secondsonaverageusingtheForceTriadTM energy platform.

LigaSureTM instruments have been found to:

• Havethehighestburstpressureandfastestsealingtimeandwerehighestratedoverallcomparedto Gyrus PKSTM*,HarmonicACE®*andEnSeal®*1

• Reducebloodlosscomparedtosutures2,3

• Reduceproceduretimecomparedtosutures2,3 • Reducepatientlengthofstaycomparedtosutures2 • Reducemeancostpercasecomparedtostaplesandclips4

More than 200 studies have been published about LigaSureTMtechnologyinpeer-reviewedjournals.I am confident using a technology backed by such a significant body of evidence-based research.

Thankyouforreviewingthisinformation.Pleasefeelfreetocontactmeifyouhaveanyquestions.

Sincerely,

AdditionalComments:

1. LambertonGR,HsiRS,JinDH,LindlerTU,JellisonFC,BaldwinDD.Prospectivecomparisonoffourlaparoscopicvesselligationdevices.J Endourol. 2008;22(10):2307-2312. 2. DingZ,WableG,RaneA.UseofLigasurebipolardiathermysysteminvaginalhysterectomy.J Obstet Gynaecol. 2005;25(1): 49-51. 3. LevyB,EmeryL.Randomizedtrialofsutureversuselectrosurgicalbipolarvesselsealinginvaginalhysterectomy.Obstet Gyne col. 2003; 102(1):147-151.4. MarcelloPW,etal.Vascularpedicleligationtechniquesduringlaparoscopiccolectomy:aprospectiverandomizedtrial.Surg Endosc. 2006;20(2):263-269.

*OnlywhenusingtheForceTriadTM 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 Ethicon

Endo-Surgery, Inc. Gyrus PKSTM* is a trademark of Gyrus ACMI. Other ™ marked brands are trademarks of a Covidien company.

© 2010 Covidien. All rights reserved. R0013674 Rev. 2010/04


303-530-2300 [t]


Product overview

LigaSure AdvanceTM Pistol Grip

OverviewThe LigaSure AdvanceTM 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 AdvanceTM pistol grip instrument has the added benefit of a dissecting electrode that utilizes ValleylabTM mode; a proprietary energy wave form. The LigaSure AdvanceTM pistol grip 5 mm instrument is intended for use ONLY with the ForceTriadTM energy platform.

SpecialtiesColorectalGynecologyUrologyGeneral Surgery

Order InformationOrdering code: LF5544Ordering quantity: 6 units/case

SpecificationsSterile, single useShaft length: 44 cmShaft diameter: 5 mmShaft rotation: 340 degreesJaw angle: curvedSeal width: 2 mm - 3 mmMonopolar electrode length: 1 mmCut length: approx. 15.5 mmJaw length: 18 mm

The Ligasure AdvanceTM pistol grip 5 mm instrument is only compatible with the ForceTriadTM 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.© 2010 Covidien. All rights reserved. R0013678 Rev. 2010/04


303-530-2300 [t]


CliniCal information

Compared to mechanical ligation techniques, LigaSureTM technology has been shown to:

Significantly reduce operating time and blood loss in urologic surgery1

Significantly reduce procedure time in colorectal surgery2, 3

Significantly reduce mean cost per case and ligation failures4

Significantly reduce perioperative blood transfusions in general and gynecologic surgery5, 6

Significantly reduce procedure time and length of hospital stay in gynecologic surgery7

Compared to other energy-based modalities, LigaSureTM technology has been shown to: Significantly reduce operative blood loss in colorectal, general and gynecological surgery8, 9, 10, 11

Significantly reduce procedure time in colorectal, general and gynecological surgery8, 10, 11

References 1. Leonardo C, et al. Laparoscopic nephrectomy using Ligasure system: preliminary experience. J Endourol. 2005;19(8):976-978. 2. Manasia P, et al. Ligasure versus sutures in bladder replacement with Montie ileal neobladder after radical cystectomy. Arch Ital Urol Androl. 2003;75(4):199-201. 3. 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):CR224-230.4. Marcello PW, et al. Vascular pedicle ligation techniques during laparoscopic colectomy: a prospective randomized trial. Surg Endosc. 2006;20(2):263-269.5. Romano F, Gelmini R, Caprotti R, et al. Laparoscopic splenectomy: ligasure versus EndolGIA: a comparative study. J Laparoendosc Adv Surg Tech. 2007;17(6):763-767. 6. Tamussino K, et al. Electrosurgical bipolar vessel sealing for radical abdominal hysterectomy. Gynecologic Oncology. 2004;96(82):320-322. 7. Ding Z, Wable G, Rane A. Use of Ligasure bipolar diathermy system in vaginal hysterectomy. J Obstet Gynaecol. 2005;2591): 49-51.8. Guerrieri M, et al. Use of the electrothermal bipolar vessel system (EBVS) in laparoscopic adrenalectomy: a prospective study. Surg Endosc. 2008 Jan;22(1):141-5. 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):1526-1531.10. 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):341-345.11. Araki Y, Noake T, Kanazawa M, et al. Clipless hand-assisted laparoscopic total colectomy using Ligasure Atlas. Kurume Med J. 2004;51(2): 105- 108.

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.© 2010 Covidien. All rights reserved. R0013679 Rev. 2010/04


303-530-2300 [t]


Cross-rEfErEnCE

Vendor Catalog # Description DiameterShaft

LengthHand

SwitchingSealing

Independent of Cutting

Generator Description

Covidien LF5544LigaSure AdvanceTM pistol grip laparoscopic instrument

5 mm 44 cm Yes YesForceTriadTM Energy Platform

Covidien Ls1500 LigasureTM 5 mm dolphin tip

5mm 37 cm Yes YesforceTriadTM Energy Platform

Covidien Ls1037 Ligasure AtlasTM 10 mm 10 mm 37 cm Yes YesforceTriadTM Energy Platform

Covidien Lf1537 LigasureTM 5 mm blunt tip 5 mm 37 cm Yes YesforceTriadTM Energy Platform

Ethicon nsEAL-335H Enseal®* TrIo device, curved round tip

5 mm 35 cm Yes Yes Enseal®* Generator

Ethicon nsEAL-345H Enseal®* TrIo device, curved round tip


Ethicon nsEAL-535H Enseal®* device standard tip


Ethicon nsEAL-525rH Enseal®* round tip 5 mm 25 cm Yes Yes Enseal®* Generator



Ethicon ETrIo-525H Enseal®* device standard tip


Ethicon ETrIo-545H Enseal®* device standard tip


The multifunctional LigaSure AdvanceTM pistol grip 5 mm instrument can potentially replace a combination of the following devices within these areas:

Vessel Sealing Devices1

Ethicon ACE36EHarmonic ACE®* with ergonomic grip

5 mm 36 cm Yes no Harmonic®* Generator

Ethicon ACE36PHarmonic ACE®* with pistol curved handle


Ethicon ACE45EHarmonic ACE®* Curved shears


Ethicon LCsC5HAHarmonic scalpel®* Hand Controlled Curved shears


Ethicon LCsC5LHarmonic scalpel®* long 5 mm Curved shears, pistol grip


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.

Other Energy-Based Devices2

Cross-rEfErEnCE

Ethicon LCsK5Harmonic®* LCs, pistol grip


olympus/Gyrus 3005-020 CUT/fCP 5 mm 33 cm no no Gyrus Generator

olympus/Gyrus 3006-020 CUT/fCP 5 mm 33 cm no no Gyrus Generator

olympus/Gyrus 3005PK3 CUT/fCP 5 mm 33 cm no no Gyrus Generator

olympus/Gyrus 920000PK PKsTM* CUT/fCP 5 mm 24 cm no no Gyrus Generator



olympus/Gyrus 006908-910CoAGTM* Bipolar Laparoscopy Probes

5 mm 32 cm n/A n/A Gyrus Generator

olympus/Gyrus 3527-000 L-Hook w/sheath 5mm 33 cm n/A n/A Gyrus Generator

olympus/Gyrus 956005PC Plasma J-Hook 5 mm 24 cm n/A n/A Gyrus Generator

olympus/Gyrus 956015PC Plasma J-Hook 5 mm 45 cm n/A n/A Gyrus Generator

olympus/Gyrus 952005PKPKsTM* Plasma spatula w/cord


olympus/Gyrus 952010PKPKsTM* Plasma spatula w/cord


olympus/Gyrus 3527PK L-Hook w/sheath 5 mm 33 cm n/A n/A Gyrus Generator

olympus/Gyrus 954000PK PKsTM* L-Hook, 9-pin 5 mm 33 cm n/A n/A Gyrus Generator

Covidien fT3000 force TriVerseTM 5 mm n/A Yes n/AforceTriadTM Energy Platform

Covidien E2770-36ValleylabTM solid larascopic electrode, straight spatula tip

4.8 mm 36 cm n/A n/A forceTriadTM Energy Platform

Covidien E2771-36ValleylabTM solid larascopic electrode, curved spatula tip

4.8 mm 36 cm n/A n/AforceTriadTM Energy Platform

Covidien E2771-45ValleylabTM solid larascopic electrode, curved spatula tip



LengthHand

SwitchingSealing






Other Energy-Based Devices2 (continued)


Various Manufacturers

Clip appliers n/A n/A n/A n/A n/A


stapler n/A n/A n/A n/A n/A


staple reloads n/A n/A n/A n/A n/A

Covidien 176645 Endo DissectTM 5 mm 31 cm n/A n/A n/A

Covidien 174317 Endo ClinchTM II 5 mm 31 cm n/A n/A n/A

Covidien 176643 Endo shearsTM 5 mm 31 cm n/A n/A n/A

Covidien 174601 Endo shearsTM Long 5 mm 45 cm n/A n/A n/A

Endo-Mechanical Devices3

Covidien E2772-36ValleylabTM solid larascopic electrode, wire J-hook tip


Covidien E2773-36ValleylabTM solid larascopic electrode, wire L-hook tip

4.8 mm 36 cm n/A n/AforceTriadTM Energy Platform

Covidien E2773-45ValleylabTM solid larascopic electrode, wire L-hook tip


Covidien E2774-36ValleylabTM solid larascopic electrode, flat L-hook tip

4.8 mm36 cm n/A n/A

forceTriadTM Energy Platform


3. Endo-mechanical instruments can be used for dissection, manipulation of tissue and/or ligation.

*Covidien Autosuture brand.


LengthHand

SwitchingSealing






Other Energy-Based Devices2 (continued)

Cross-rEfErEnCE

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 Ethicon

Endo-Surgery, Inc. GyrusTM*, COAGTM* and Gyrus PKSTM* are trademarks of Gyrus ACMI. Other ™ marked brands are trademarks of a Covidien company.



303-530-2300 [t]




303-530-2300 [t]


Documents

Value analysis Brief - medtronic.com · I am requesting the LigaSure AdvanceTM pistol grip 5 mm instrument be stocked in our facility so that I have consistent access to this device