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INTRODUCING THE LAPRO-CLIP SYSTEM FOR MAXIMUM SECURITY IN SURGICAL PROCEDURES Reusable Single Clip Applier Absorbable Ligating Clips Clip Remover

INTRODUCING THE LAPRO-CLIP SYSTEM FOR MAXIMUM …

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Page 1: INTRODUCING THE LAPRO-CLIP SYSTEM FOR MAXIMUM …

INTRODUCING THE LAPRO-CLIP™ SYSTEM FOR MAXIMUM SECURITY IN SURGICAL PROCEDURES

∙ Reusable Single Clip Applier

∙ Absorbable Ligating Clips

∙ Clip Remover

Page 2: INTRODUCING THE LAPRO-CLIP SYSTEM FOR MAXIMUM …

STRENGTH AND SECURITY – CRITICAL COMPONENTS TO LIGATION METHODSLigation instruments have evolved over the years, with energy-based vessel sealing devices and vascular staplers being offered as modern, sophisticated options for surgeons and hospital facilities.

But despite it all, a dependable ligation clip still proves to be a strong and secure option for performing successful surgical procedures. As a physical device applying mechanical pressure to the vessels, ligation clips keep blood pressure away from cut ends for optimal healing.

Lapro-Clip™ is your ligation solution

STRENGTHTwo-part compression closure mechanism includes anti-slip notch which may assist in the reduction of clip migration

Absorbable ligating clips for critical vessel healing time, degrades via hydrolysis in 180 days (inner track) and 90 days (outer track)

SECURITYCompression closure mechanism may provide a more secure closure than latch closure mechanism by reducing the risk of tissue interposition1

No foreign bodies left behind post-procedure

1. Darzi, A. Initial Experience with an Absorbable Laparoscopic Ligation Clip. British Journal of Surgery.1997.

COMMON CHALLENGES

MEDTRONIC LIGATION

ABSORBABLE CLIP ADVANTAGES

LAPRO-CLIP™ APPLIER

ABSORBABLE CLIPS

CLINICAL RESULTS

THE COMPETITION

SURGEON EXPERIENCES

PRODUCT CODES

RESOURCES

CLINICAL STUDIES

CONTACT US

Page 3: INTRODUCING THE LAPRO-CLIP SYSTEM FOR MAXIMUM …

WE WANT YOU TO FEEL STRONG AND SECUREAt Medtronic, we offer everything from clip appliers to advanced energy technology. Each of our products is designed to keep you laser focused during crucial moments both in the OR and on your patient’s road to recovery.

With the Lapro-Clip™ system, expect a reliable and consistent experience for optimal patient outcomes. Surgeons can feel confident they are using a product that promotes efficient case completion with clips that absorb in conjunction with critical vessel healing time and a well-designed, easy-to-use applier.

Medtronic stands on reliable technologies and a strong dedication to increasing your facility’s operational and economic efficiencies. Utilize our comprehensive portfolio to provide a higher quality of care. Because when it comes to ligation, it’s not about how far we can push the envelope. It’s how securely we can seal it.

Grab hold of strong1, secure2, and cost-effective3 ligation solutions with Medtronic.

1. Klein RD. Comparison of titanium and absorbable polymeric surgical clips for use in laparoscopic cholecystectomy. Surg Endosc. 1994

2. Hawasli A. The use of absorbable clips in laparoscopic cholecystectomy. J Laparoendosc Surg. 1994.

3. Dimitrios K. Manatakis and Nikolaos Georgopoulos, “Reducing the Cost of Laparoscopy: Reusable versus Disposable Laparoscopic Instruments,” Minimally Invasive Surgery, vol. 2014, Article ID 408171, 4 pages, 2014. doi:10.1155/2014/408171

COMMON CHALLENGES

MEDTRONIC LIGATION

ABSORBABLE CLIP ADVANTAGES

LAPRO-CLIP™ APPLIER

ABSORBABLE CLIPS

CLINICAL RESULTS

THE COMPETITION

SURGEON EXPERIENCES

PRODUCT CODES

RESOURCES

CLINICAL STUDIES

CONTACT US

Page 4: INTRODUCING THE LAPRO-CLIP SYSTEM FOR MAXIMUM …

ADVANTAGES OF ABSORBABLE LIGATING CLIPS ∙ No foreign body left behind

∙ Absorbability via hydrolysis (the body’s natural substances such as lactic and glycolic acid)

∙ Radio-transparency - absorbable clips are not visible on MRI or CT scans

Clip migration may increase the risk of stone formation in:

∙ Cholecystectomies

∙ Hepatectomies

∙ Prostatectomies

∙ Partial Nephrectomies

∙ Gynecological procedures

641 patients that underwent surgical procedures requiring non-absorbable clips were monitored for over 3 years, as evaluated in a study1

∙ 6 patients experienced surgical clip-related complications

∙ Metal clip migration was associated with 8% of 25 RRP cases of bladder neck contracture, and 100% of RRP cases that involved bladder stones

1. Yi, JS, et al. Surgical Clip-Related Complications after Radical Prostatectomy. Korean Journal of Urology. 2010. Vol 51: 683-687.

DISCOVER THE UNIQUE FEATURES OF THE LAPRO-CLIP™ SYSTEM NEXT

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COMMON CHALLENGES

MEDTRONIC LIGATION

ABSORBABLE CLIP ADVANTAGES

LAPRO-CLIP™ APPLIER

ABSORBABLE CLIPS

CLINICAL RESULTS

THE COMPETITION

SURGEON EXPERIENCES

PRODUCT CODES

RESOURCES

CLINICAL STUDIES

CONTACT US

Page 5: INTRODUCING THE LAPRO-CLIP SYSTEM FOR MAXIMUM …

INTRODUCING THE SECURE MEDTRONIC SOLUTIONTHE LAPRO-CLIP™ LIGATION SYSTEM

KEY FEATURES

∙ Available in 26.5 cm (standard) and 33 cm (long)*

∙ Designed to be used with a 10 mm trocar

∙ Packaged non-sterile and designed for re-use

Intuitive, easy-to-use design

Clip compression closure mechanism may provide a more secure closure than clips with latch closure mechanism by reducing the risk tissue mechanism1

*Long shaft (33 cm) is reusable for up to 50 sterilization cycles1. Darzi, A. et al. Initial experience with an absorbable laparoscopic ligation clip. British Journal of Surgery 1997

Reusable Single Clip Applier

Shaft rotates 360° so all angles are reachable

COMMON CHALLENGES

MEDTRONIC LIGATION

ABSORBABLE CLIP ADVANTAGES

LAPRO-CLIP™ APPLIER

ABSORBABLE CLIPS

CLINICAL RESULTS

THE COMPETITION

SURGEON EXPERIENCES

PRODUCT CODES

RESOURCES

CLINICAL STUDIES

CONTACT US

Page 6: INTRODUCING THE LAPRO-CLIP SYSTEM FOR MAXIMUM …

THE LAPRO-CLIP™ LIGATION SYSTEM

Lapro-Clip™ absorbable clipsLapro-Clip™ absorbable clips are fully degraded in the body via hydrolysis after 180 days (inner track) and 90 days (outer track).

KEY FEATURES

∙ Dual-layer clip lock mechanism – locks the distal end of the outer layer with the distal notch of the inner layer to secure the clip, providing optical ligation security

∙ Distal end closure – optimizes inclusion of the blood vessel in the clip and reduces the risk of mid-ligation slippage, using a two-part compression closure mechanism

∙ Radiotransparency – Lapro-Clip™ absorbable clips do not interfere with the magnetic field of x-ray, CT or MRI scans

CLOSING SEQUENCE

1.

3.

2.

4.

Dual-Layered Clip Lock

Soft Flexible Inner Layer

Rigid Outer Layer

Anti-slip notch

COMMON CHALLENGES

MEDTRONIC LIGATION

ABSORBABLE CLIP ADVANTAGES

LAPRO-CLIP™ APPLIER

ABSORBABLE CLIPS

CLINICAL RESULTS

THE COMPETITION

SURGEON EXPERIENCES

PRODUCT CODES

RESOURCES

CLINICAL STUDIES

CONTACT US

Page 7: INTRODUCING THE LAPRO-CLIP SYSTEM FOR MAXIMUM …

A STRONG CASE FOR CHOOSING LAPRO-CLIP™

High degree of operator satisfaction with Lapro-Clip™ loading mechanism, security, and clip closure1

post-op, absorbable clip maintained 80% strength3

In an animal study, absorbable clips retention force provides greater holding strength than titanium clips3

Lapro-Clip™ absorbable polymer clips compression closure mechanism may provide a more secure closure than clips with latch closure mechanisms by reducing the risk of tissue interposition1

Use of absorbable clip may decrease incidences associated with metal clips4

of patients (n=233) experienced satisfactory results at 1-month post-op1

1 day with CLIPS

More than4 days with SUTURES

vs

vs

time taken to physiologically secure ligated arteries2

7 days with CLIPS

14 days with SUTURES

time needed for maximum security of arteries2

OVER 99%

7 DAYS

1. Darzi, A. et al. Initial experience with an absorbable laparoscopic ligation clip. British Journal of Surgery 1997.2. Brohim, RM, et al. Development of Independent Vessel Security after Ligation with Absorbable Sutures or Clips. The American Journal of Surgery 1993. 3. Klein, RD, et al. Comparison of Titanium and Absorbable Polymeric Surgical Clips for Use in Laparoscopic Cholecystectomy. Surgical Endoscopy 1994 . 4. Hawasli, A. The Use of Absorbable Clips in Laparoscopic Cholecyctectomy. Journal of Laparoendoscopic Surgery. 1994.

COMMON CHALLENGES

MEDTRONIC LIGATION

ABSORBABLE CLIP ADVANTAGES

LAPRO-CLIP™ APPLIER

ABSORBABLE CLIPS

CLINICAL RESULTS

THE COMPETITION

SURGEON EXPERIENCES

PRODUCT CODES

RESOURCES

CLINICAL STUDIES

CONTACT US

Page 8: INTRODUCING THE LAPRO-CLIP SYSTEM FOR MAXIMUM …

LAPRO-CLIP™ OUTPERFORMS OTHER POLYMER CLIP PRODUCTS1. CLIP RETENTION FORCETwo-part compression closure mechanism includes anti-slip notch

∙ Anti-slip notch may assist in the reduction of clip migration

2. UNIQUE FRONT-TO-BACK LOCKING ACTIONLapro-Clip™ closes front to back (distal to proximal) while Hem-o-lok™* clip closes from back to front(proximal to distal)

∙ Tissue hydraulics will allow tissue to extrude out of the jaws with a back to front closure1

1. Covidien Internal Benchmark - Lapro-Clip™ vs Weck Hem-o-lock™*; RDTS report CMP 6301 August 2014.

COMMON CHALLENGES

MEDTRONIC LIGATION

ABSORBABLE CLIP ADVANTAGES

LAPRO-CLIP™ APPLIER

ABSORBABLE CLIPS

CLINICAL RESULTS

THE COMPETITION

SURGEON EXPERIENCES

PRODUCT CODES

RESOURCES

CLINICAL STUDIES

CONTACT US

Page 9: INTRODUCING THE LAPRO-CLIP SYSTEM FOR MAXIMUM …

SURGEON EXPERIENCESCOMMON CHALLENGES

MEDTRONIC LIGATION

ABSORBABLE CLIP ADVANTAGES

LAPRO-CLIP™ APPLIER

ABSORBABLE CLIPS

CLINICAL RESULTS

THE COMPETITION

SURGEON EXPERIENCES

PRODUCT CODES

RESOURCES

CLINICAL STUDIES

CONTACT US

Dr. Daniel D. Eun Vice Chief, Robotic Surgery Temple University Hospital

Page 10: INTRODUCING THE LAPRO-CLIP SYSTEM FOR MAXIMUM …

PRODUCT REORDER CODE INFORMATION

COMPETITIVE PRODUCT CROSS REFERENCE GUIDE

REORDER CODE DESCRIPTION CLIPS PER STERILE PACK STERILE PACK PER BOX

8886848700 Lapro-Clip™ Reusable Single Clip Applier – Standard (METAL INSTR) - 1

8886848701 Lapro-Clip™ Reusable Single Clip Applier – Long (METAL INSTR) - 1

8886848808 Lapro-Clip™ 8 mm Absorbable Clips (6 clips/package) 6 6

8886848882 Lapro-Clip™ 8 mm Absorbable Clips (2 clips/package) 2 10

8886848812 Lapro-Clip™ 12 mm Absorbable Clips (6 clips/package) 6 6

8886848813 Lapro-Clip™ 12 mm Absorbable Clips (2 clips/package) 2 10

8886848814 Lapro-Clip™ 8 mm Absorbable Clips (1 clip/package) 1 10

8886848815 Lapro-Clip™ 12 mm Absorbable Clips (1 clip/package) 1 10

ITEM CODE (SKU #)

COMPETITIVE PRODUCT EACH/STERILE PACKS PER BOX

CLIPS PER STERILE PACK

REPLACE WITH THIS MEDTRONIC PRODUCT

544995 Endo 10™* L, 32 cm Applier, 10 mm - - 8886848701 - Lapro-Clip™ Reusable Single Clip Applier – Long

544230 Hem-o-lok™* Medium-Large Polymer Clips

14 6 8886848808 - Lapro-Clip™ 8 mm Absorbable Clips (6 clips/package)

544240 Hem-o-lok™* Large Polymer Clips 14 6 8886848812 - Lapro-Clip™ 12 mm Absorbable Clips (6 clips/package)

COMMON CHALLENGES

MEDTRONIC LIGATION

ABSORBABLE CLIP ADVANTAGES

LAPRO-CLIP™ APPLIER

ABSORBABLE CLIPS

CLINICAL RESULTS

THE COMPETITION

SURGEON EXPERIENCES

PRODUCT CODES

RESOURCES

CLINICAL STUDIES

CONTACT US

Page 11: INTRODUCING THE LAPRO-CLIP SYSTEM FOR MAXIMUM …

IMPORTANT LAPRO-CLIP™ RESOURCES

Lapro-Clip™ Sterilization brochure

Infographic Medtronic website

Lapro-Clip™ Sell Sheet

LAPRO-CLIP™

ABSORBABLE CLIP APPLIER FOR MINIMALLY INVASIVE SURGERY

Dual layer clip lock

∙ In an animal study, absorbable clips retention force provides greater holding strength than titanium clips1

Two-part compression

∙ Closure mechanism includes anti-slip notch

Reusable single clip applier

∙ Intuitive easy-to-use design with 360° rotation to reach every angle

Absorbable polymer clips

∙ Degrades via hydrolysis in 180 days (inner track) and 90 days (outer track) Lapro-Clip™ loading mechanism, security and clip closure

∙ High degree of operator satisfaction with the clip mechanism, loading and clip security as compared to clips with latch mechanism2

PRODUCT BENEFITS

RANGE OF VALUE CHOICES TO ENABLE THE HIGHEST QUALITY, COST-EFFECTIVE SURGICAL CARE.

Experience the Lapro-Clip™ ligation system today

1. Klein RD. Comparison of titanium and absorbable polymeric surgical clips for use in laparoscopic cholecystectomy. Surg Endosc. 1994.2. Dell’Abate P. Choledocholithiasis caused by migration of a surgical clip after video laparoscopic cholecystectomy. J Laparoendosc Adv Surg Tech A. 2003.3. Darzi A. Initial experience with an absorbable laparoscopic ligation clip. Br J Surg. 1997.4. Based on internal benchmark RDTS report CMP 6301. Lapro-Clip™ ligation system vs Weck™* Hem-o-lok™*. August 2014.5. Blumenthal KB, et al. Bladder neck contractures related to the use of Hem-o-Lok™* clips in robot-assisted laparoscopic radical prostatectomy. Urology. 2008; 72(1):158-161.6. In a 2003 ASTS survey, 213 respondents experienced 8 failures of Clavien 3b category. Friedman AL, Peters TG, Jones KW, et al. Fatal and nonfatal hemorrhagic complications of living kidney donation. Ann Surg. 2006; 243:126-130.7. Hawasli A. The use of absorbable clips in laparoscopic cholecystectomy. J Laparoendosc Surg. 1994.

Procedural satisfaction3

of patients (n=233) in a clinical study experienced satisfactory results at 1-month post-op3

High degree of operator satisfaction with Lapro-Clip™ ligation system’s loading mechanism, security and clip closure interposition3

Complications with Weck™* Hem-o-lok™*5

4 out of 524 patients developed bladder neck contractures (BNC) following robot-assisted laparoscopic prostatectomy (RALP)5 Hem-o-lok™* clip found in 2 patients with obstructive lower urinary tract symptoms developing BNC that did not respond to dilation or transurethral incision5

2 cases of Hem-o-lok™* clip migration into the urinary tract5 28 additional reported adverse events from July 2005 to June 20075

Several Hem-o-lok™* clips found in a patient with pelvic bleed and recurrent clot retention5 Locking clips may result in delayed hemorrhage6

Absorbable advantages

In an animal study, 7 days post-op, absorbable clip maintained 80% strength1

Use of absorbable clip may decrease incidences associated with metal clips such as migration into common bile duct causing stone formation, interference with magnetic field of CT or MRI scans 7

Contact your Medtronic representative or visit us online at medtronic.com/covidien

© 2016 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. ™* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. 16-eu-lapro-clip-infographic-1435540

Absorbable clips vs. metallic clipsIn an animal study, absorbable clips retention force provides greater holding strength than titanium clips1

Lapro-Clip™ absorbable polymer clips’ compression closure mechanism may provide a more secure closure than clips with latch closure mechanisms by reducing the risk of tissue interposition3

OVER 99%

GET A FIRM GRASP ON LIGATION

Polymeric absorbable clips are an acceptable alternative to metallic clips in laparoscopic cholecystectomy.1, 2

Making the case for the Lapro-Clip™

ligation system

Two-part compression closure mechanism includes anti-slip notch Anti-slip notch may assist in the reduction of clip migration2,4,7

Lapro-Clip™ absorbable polymer clip closes front to back (distal to proximal) while Weck™* Hem-o-lok™* clip closes from back to front (proximal to distal) Tissue hydraulics may allow tissue to extrude out of the jaws with a back-to-front closure4

Lapro-Clip™ absorbable clips vs. the competition

COMMON CHALLENGES

MEDTRONIC LIGATION

ABSORBABLE CLIP ADVANTAGES

LAPRO-CLIP™ APPLIER

ABSORBABLE CLIPS

CLINICAL RESULTS

THE COMPETITION

SURGEON EXPERIENCES

PRODUCT CODES

RESOURCES

CLINICAL STUDIES

CONTACT US

REPROCESSING,CLEANING AND STERILIZATIONPROCEDURES

Lapro-Clip™ reusable single clip applier

Always refer to the instructions for use (IFU) supplied with the Lapro-Clip™ reusable single clip applier handles for complete indications, contraindications, warnings, precautions and instructions prior to use.

Page 12: INTRODUCING THE LAPRO-CLIP SYSTEM FOR MAXIMUM …

ADDITIONAL KEY CLINICAL STUDIES

Gronau, E. & Panne L (2004). Reflux of a Staple after Kock Pouch Urinary Diversion: A Nidus for Renal Stone Formation. Journal of Endourology. 18(5): 481-482.

Miller, M. et al (2006). Resorbable Clip Migration in the Collecting System after Laparoscopic Partial Nephrectomy. Journal of Urology. Doi:10.1016.

Massoud, W.A. (2011). Spontaneous Migration of a Surgical Clip Following Partial Nephrectomy. Urology Journal. 8(2): 153-154.

Kadekawa,K. et al (2009). Migration of a Metal Clip into the Urinary Bladder. Urology Reserve. 37: 117-119.

Dell’Abate, P. et al (2003). Choledocholithiasis Caused by Migration of a Surgical Clip after Video Laparoscopic Cholecystectomy. Journal of Laparoendoscopic & Advanced Surgical Technique. 13 (3): 203-204.

It has been known for 30 years that nonresorbable staples may serve as a nidus for urinary stone formation if they are in contact with urine.

Within the general surgical literature, several groups have reported clips from laparoscopic cholecystectomies migrating into the common bile duct and acting as a nidus for stone formation.

These reports prompted the use of absorbable clips to avoid this complication.

Migration of surgical materials into the urinary tract is a rare condition.

Metal clips may migrate postoperatively and cause secondary complications.

Metal clips should be used sparingly at the vesicouerthral anastomosis when performing retropubic radical prostatectomy.

A metallic clip can erode through tissue and obstruct the bile duct or impede bile flow. Use resorbable clips to close the cystic duct and artery.

Study Title Key Conclusion

COMMON CHALLENGES

MEDTRONIC LIGATION

ABSORBABLE CLIP ADVANTAGES

LAPRO-CLIP™ APPLIER

ABSORBABLE CLIPS

CLINICAL RESULTS

THE COMPETITION

SURGEON EXPERIENCES

PRODUCT CODES

RESOURCES

CLINICAL STUDIES

CONTACT US

Page 13: INTRODUCING THE LAPRO-CLIP SYSTEM FOR MAXIMUM …

LET’S START THE CONVERSATION TODAYLearn more about the Lapro-Clip™ ligation system and other products in the Medtronic portfolio.

Contact your Medtronic Sales Representative today.

Visit us online:medtronic.com/covidien/uk

COMMON CHALLENGES

MEDTRONIC LIGATION

ABSORBABLE CLIP ADVANTAGES

LAPRO-CLIP™ APPLIER

ABSORBABLE CLIPS

CLINICAL RESULTS

THE COMPETITION

SURGEON EXPERIENCES

PRODUCT CODES

RESOURCES

CLINICAL STUDIES

CONTACT US

Page 14: INTRODUCING THE LAPRO-CLIP SYSTEM FOR MAXIMUM …

IMPORTANT: Please refer to the package insert for complete instructions, contraindications, warnings and precautions.

© 2020 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. ™* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. 20-weu-lapro-clip-e-book-4732379

medtronic.com/covidien/en-gb/index.html