Healthcare Industry News:  surgical stapler 

Devices Surgery

 News Release - May 23, 2007

GORE SEAMGUARD(R) Bioabsorbable Staple Line Reinforcement Now Configured for Circular Staplers in Bariatric Surgery

Preliminary Data Shows a Statistically Significant Reduction in Anastomotic Stricture Rate and Trends toward Decreased Anastomotic Bleeding and Leak Rates

FLAGSTAFF, Ariz.--(HSMN NewsFeed)--W. L. Gore & Associates (Gore) announced today that early clinical results presented at the annual Society of American Gastrointestinal Endoscopic Surgeons (SAGES) meeting in Las Vegas, Nev., include statistically significant data showing GORE SEAMGUARDŽ Bioabsorbable Staple Line Reinforcement, now configured for circular staplers, reduces anastomotic stricture rate, as well as trends toward anastomotic bleeding and leak rates, in bariatric surgery.

The first synthetic, bioabsorbable material of its kind, GORE SEAMGUARDŽ Bioabsorbable Staple Line Reinforcement for circular surgical staplers is indicated for bariatric procedures where soft tissue anastomosis with staple line reinforcement is needed. The biomaterial is composed of a copolymer glycolide (PGA) and trimethylene carbonate (TMC) microporous structure with an extensive history of safety in sutures, surgical meshes and implantable devices.

During the SAGES 2007 Emerging Technology Poster Session, Dr. Eric Bour, Hillcrest Hospital (part of the Greenville Hospital System) presented data from a retrospective study comparing 269 patients before adoption of GORE SEAMGUARDŽ Bioabsorbable Staple Line Reinforcement and the first 90 cases after adoption, with a mean follow-up of seven months. The study indicated a statistically significant reduction in anastomotic stricture rate and trends towards a decrease in anastomotic bleeding and leak rates with the GORE biomaterial.(1)

Gore Product Specialist Jason Smith commented, "With GORE SEAMGUARDŽ Bioabsorbable Staple Line Reinforcement, surgeons performing soft tissue surgeries can realize the same benefits using circular staplers as they did with endoscopic and linear staplers. This innovative material has proven to be a safe, effective solution for reinforcing staple lines during bariatric, colorectal, and gastrointestinal procedures."

According to Smith, Gore is actively working with leading surgeons in the areas of both bariatric and colorectal surgery to address clinical issues of anastomotic integrity. Gore offers a full portfolio of products for staple line reinforcement, including GORE SEAMGUARDŽ Staple Line Reinforcement and GORE SEAMGUARDŽ Bioabsorbable Staple Line Reinforcement.

Smith said, "We are pleased with the promising clinical data for GORE SEAMGUARDŽ Bioabsorbable Staple Line Reinforcement for circular surgical staplers, and are actively working to further demonstrate the benefits of the material."

GORE SEAMGUARDŽ Bioabsorbable Staple Line Reinforcement is thinner than other reinforcement materials, and is completely absorbed within six months--eliminating the risk of erosion into adjacent tissue. Since the material is entirely synthetic, it does not carry the risk of animal-source contamination. This bioabsorbable membrane also has less risk of long-term complications associated with permanent materials, such as migration, erosion, calcification and providing a nidus for infection.

ABOUT W. L. GORE & ASSOCIATES, INC.

The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, Gore has implanted more than 23 million innovative medical devices, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical patches and meshes for hernia repair, and sutures for use in vascular, cardiac, general surgery and orthopedic procedures. Gore was recently named the tenth best company to work for in the United States by Fortune Magazine.

(1) Wesley B. Jones MD, Katherine M. Myers, Eric S. Bour MD, Greenville Hospital System University Medical Center, Department of Surgery, Greenville, SC USA. Early clinical results using GORE SEAMGUARDŽ Bioabsorbable Staple Line Reinforcement (CBSG) for circular staplers. SAGES Emerging Technology Poster Session, April 2007.

Products listed may not be available in all markets pending regulatory clearance.

GORE, SEAMGUARDŽ, and design are trademarks of W. L. Gore & Associates.


Source: W. L. Gore

Issuer of this News Release is solely responsible for its content.
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