W. L. Gore & Associates, Inc. (Gore) today (19 Jan) announced that GORE SYNECOR Biomaterial, a unique biomaterial for hernia repair, has received 510K clearance from the U.S. Food and Drug Administration (FDA). The new product combines two proven technologies to create a cost effective, single-stage hernia repair with well vascularized ingrowth for use in open, laparoscopic, and robotic cases.
Hernia repair has traditionally required a surgeon to choose between a permanent material for a durable, single-stage repair, and absorbable, non-permanent materials when there is contamination or other factors which may require a different approach. GORE SYNECOR Biomaterial is comprised of three proven materials, including:
- Dense monofilament polytetrafluoroethylene (PTFE) macroporous knit that provides strength and reduces the risk of harboring bacteria due to the solid fiber
- GORE BIO-A Web, a tissue scaffold with proven outcomes in contaminated hernia repair1, providing rapid vascularization and ingrowth for complex repairs
- Non-porous PGA/TMC film that minimizes tissue attachment to the device at the visceral side
With this unique structure, surgeons no longer need to compromise by choosing one material or the other depending on patient complexity.
“Hernia repair is one of the most common surgeries performed globally,” said Ron Anderson, General Surgical Products Business Unit Leader, “We expect that this new composite material will make a positive impact on patient outcomes, providing value for surgeons, hospitals and patients.”
No pre-certification is required for surgeons to implant GORE SYNECOR Biomaterial. However, Gore provides operating room support and peer-to-peer educational courses for interested surgeons.
Gore is actively participating in a Clinical Quality Improvement study to procure real world feedback from surgeons and patients about GORE SYNECOR Biomaterial.
References
1Rosen M, Bauer JJ, Harmaty M, et al. Multicenter, prospective, longitudinal study of the recurrence, surgical site infection, and quality of life after contaminated ventral hernia repair using biosynthetic absorbable mesh: the COBRA Study. Annals of Surgery. In press.
