Patient Enrollment Begins in Study on Efficacy of GORE SEAMGUARD® Staple Line Reinforcement for Circular Surgical Staplers
More Than 2,500 Colorectal Implants of GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement for Circular Surgical Staplers in Past Year
Flagstaff, AZ (June 7, 2008) - W. L. Gore & Associates (Gore) today announced that patient enrollment has begun in a study entitled, "Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal and Coloanal Anastomoses."The primary purpose of this prospective, randomized multicenter study is to evaluate and compare the outcomes of high risk colorectal or coloanal anastomoses constructed with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement for circular surgical staplers to standard non-reinforced colorectal and coloanal techniques with respect to the incidence of postoperative anastomotic leakage, anastomotic stricture and time to ileostomy closure. The first synthetic, bioabsorbable material of its kind, GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement is used widely in procedures where soft tissue anastomosis with staple line reinforcement is needed and has been used in more than 2,500 colorectal procedures over the past year alone.
The Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal and Coloanal Anastomoses study will include approximately 750 patients undergoing low anterior resection at twelve to fourteen centers throughout the US and Europe. The patients will be followed through ileostomy closure and will be evaluated for post-operative complications, including anastomotic leaks or strictures. The GORE SEAMGUARD® Material will be utilized and compared with standard technique of no staple line reinforcement.
According to Anthony Senagore, MD, MS, MBA at the Ferguson Clinic, Grand Rapids, MI and Principal Investigator for the Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal and Coloanal Anastomoses study, "Minimizing postoperative leaks and stricture associated with high risk anastomoses is a critical issue in low anterior resections. The design of the Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal and Coloanal Anastomoses study is such that we expect to get important data about the effectiveness of bioabsorbable staple line reinforcement material in anastomoses as compared to no reinforcement, as is often done today."
Morris E. Franklin, MD, FACS at the Texas Endosurgery Institute, and fellow Investigator for the Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal and Coloanal Anastomoses study, added, "While the bariatric surgery community well understands the benefits of GORE SEAMGUARD® Material in reducing the incidence of perioperative leaks and bleeding in a variety of open and minimally invasive surgeries, a clearer picture of its efficacy in low anterior resections will be welcomed."
"Gore continues to work closely with leading surgeons in colorectal surgery to further demonstrate the benefits of the GORE SEAMGUARD Material and address anastomotic integrity. This study will provide further insights into utilizing GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement as a means of lowering the rate of postoperative anastomotic leakage and stenosis in high-risk stapled colorectal and coloanal anastomoses," added Jason Smith, Product Specialist with Gore.
GORE SEAMGUARD 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. The microporous biomaterial is composed of a glycolide (PGA) and trimethylene carbonate (TMC) copolymer with an extensive history of safety in sutures, surgical meshes and implantable devices. 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
Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 25 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 materials 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 11th consecutive year. For more information, visit http://www.goremedical.com.
Erik Clausen or Kena Hudson
Schwartz Communications, Inc. for W. L. Gore & Associates
Products listed may not be available in all markets pending regulatory clearance. GORE, SEAMGUARD®, and design are trademarks of W. L. Gore & Associates.