20 YEARS GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement

This milestone is about you

Thank you to all who helped GORE® SEAMGUARD® Reinforcement achieve an unrivaled legacy of clinical performance,* impacting millions of patients† over 20 years.‡

Millions of patients impacted† Icon

Millions of patients impacted†

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Simplify inventory

Designed to work with a wide range of staplers, including robotic staplers.

 

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Reduce overall postoperative complication costs

Provides reliable protection from surgical complications associated with leaks and bleeding, along with reduced reoperations and readmissions.1-6

 

leak rate icon

 

Leak rate

Less than 0.39% in the U.S. (0.7 % overall.)2

 

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Protects against bleeding

Randomized prospective data has shown that the GORE® SEAMGUARD® Reinforcement significantly reduces bleeding.3,4

 

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85+ clinical studies

published and peer-reviewed.*

 

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Unrivaled legacy of clinical performance* Icon

Unrivaled legacy of clinical performance*

* After 20 years,‡ over 5 million devices implanted† and more than 85 published and peer-reviewed clinical studies,†,1 GORE® SEAMGUARD® Reinforcement has demonstrated an unrivaled legacy of clinical performance, providing reliable protection from surgical complications associated with leaks2 and bleeding.3,4

† Data on file 2022; W. L. Gore & Associates, Inc; Flagstaff, AZ.

‡ First commercial marketing authorization, U.S. Food and Drug Administration in April 2003.

  1. W. L. Gore & Associates, Inc. Clinical Performance with Staple Line Reinforcement. Scientific Literature Analysis (n = 8142 patients). Flagstaff, AZ: W. L. Gore & Associates, Inc; 2021. [Literature summary]. 2161018-EN.
  2. Gagner M, Kemmeter P. Comparison of laparoscopic sleeve gastrectomy leak rates in five staple-line reinforcement options: a systematic review. Surgical Endoscopy 2020;34(1):396-407. https://rd.springer.com/article/10.1007/s00464-019-06782-2
  3. Miller KA, Pump A. Use of bioabsorbable staple reinforcement material in gastric bypass: a prospective randomized clinical trial. Surgery for Obesity & Related Diseases 2007;3(4):417-422.
  4. Nguyen NT. Longoria M, Welbourne S, Sabio A, Wilson SE. Glycolide copolymer staple-line reinforcement reduces staple site bleeding during laparoscopic gastric bypass. A prospective randomized trial. Archives of Surgery 2005;140(8):773-778
  5. Zambelli-Weiner A, Brooks E, Brolin R, Bour ES. Total charges for postoperative leak following laparoscopic sleeve gastrectomy. Presented at Obesity Week 2013: The American Society for Metabolic and Bariatric Surgery and the Obesity Society Joint Annual Scientific Meeting; November 11-16, 2013; Atlanta, GA. A-305-P.
  6. Gayrel X, Loureiro M, Skalli EM, Dutot C, Mercier G, Nocca D. Clinical and economic evaluation of absorbable staple line buttressing in sleeve gastrectomy in high-risk patients. Obesity Surgery 2016;26(8):1710-1716.

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Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly

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