Healthcare Industry News:  tissue scaffold 

Devices Surgery Regulatory

 News Release - June 13, 2011

Gore Receives Health Canada Approval for GORE(R) SEAMGUARD(R) Bioabsorbable Staple Line Reinforcement

Proven Performance with More than 500,000 Successful Implants Worldwide

FLAGSTAFF, Ariz.--(Healthcare Sales & Marketing Network)-- W. L. Gore & Associates, Inc. (Gore) today announced at the American Society for Metabolic and Bariatric Surgery Meeting that it has received approval from Health Canada for GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement. The device is specifically engineered to reduce the incidence of perioperative leaks and bleeding in a variety of open and minimally invasive surgeries. With more than 15 years of bioabsorbable material technology research and clinical use supporting it, GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement has a proven record of safety. Worldwide, more than 500,000 successful implants have been completed and more than 40 clinical papers have documented its successful use in bariatric, colorectal and thoracic procedures.

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement is 100 percent bioabsorbable with a synthetic tissue scaffold. It is engineered for consistent thinness to allow proper staple formation. While providing added strength to the staple line during the critical healing process, this reinforcement is gradually and predictably absorbed, usually within six months. The risk of a prolonged inflammatory response is eliminated.

“We routinely use GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement in surgery. This bioabsorbable material reduces staple line hemorrhage and the leakage rate,” said Michel Gagner, M.D. FRCSC, FACS, FASMBS, FICS, AFC (Hon.) Clinical Professor of Surgery, Department of Surgery, Hospital du Sacre Coeur affiliated to the University of Montreal, Montreal, QC, Canada and Herbert Wertheim College of Medicine, Florida International University, Miami, Florida.

Constructed from Polyglycolic acid:Trimethylene carbonate (PGA:TMC), a medically proven biocompatible copolymer, GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement is composed of a matrix of open, highly interconnected pores facilitating cell infiltration, tissue generation, growth and healing.

“Of all the risks associated with bariatric, colorectal, and thoracic procedures, among the most challenging is complications resulting from perioperative leaks and bleeding. GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement has proven clinical performance in minimizing leaks and bleeding,” said Ron Anderson, Associate with the Gore General Medical Products Business. “Gore is pleased to receive Heath Canada approval in order to advance care for patients in Canada.”

ABOUT W. L. GORE & ASSOCIATES

The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 30 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, soft tissue reconstruction, staple line reinforcement and sutures for use in vascular, cardiac and general surgery. Gore was recently named one of the best companies to work for by Fortune magazine for the 14th consecutive year. For more information, visit www.goremedical.com.

Products listed may not be available in all markets. GORE®, SEAMGUARD® and designs are trademarks of W. L. Gore & Associates.


Source: W. L. Gore

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