Clinical Performance with Staple Line Reinforcement: Scientific Literature Analysis

Staple line reinforcement has been applied clinically to minimize intraoperative bleeding, to decrease the occurrence of postoperative air leaks for pulmonary resections, for transection of solid organs, and for all aspects of gastrointestinal surgery to decrease intraoperative bleeding and postoperative gastrointestinal hemorrhage and leaks. The scientific literature provided in this document summarizes the clinical experience with GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement in thoracic, colorectal, pancreatic, and bariatric surgery, and confirms the following findings:

• Pancreatic surgery - reduces postoperative pancreatic stump leak and perioperative bleeding.

• Gastrointestinal surgery – reduces intraoperative staple line bleeding, with a trend toward reduction in gastrointestinal hemorrhage and staple line leaks.

• Thoracic surgery – reduces postoperative pulmonary air leak.