Unique Biomaterial for Hernia Repair Receives FDA 510K Clearance

GORE® SYNECOR Biomaterial combines strength of PTFE with the tissue-building scaffold of GORE® BIO-A® Web to create an improved device for hernia repair

Flagstaff, Ariz. (January 19, 2016) — W. L. Gore & Associates, Inc. (Gore) today 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.

  1. Rosen 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. 
    http://journals.lww.com/annalsofsurgery/pages/articleviewer.aspx?year=9000&issue=00000&article=97182&type=Abstract

ABOUT US

At Gore Medical, we have provided creative therapeutic solutions to complex medical problems for 40 years. During that time, 40 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. Our extensive family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia and soft tissue reconstruction, staple line reinforcement materials, and sutures for use in vascular, cardiac, and general surgery. We are one of a select few companies to appear on all of the U.S. "100 Best Companies to Work For" lists since the rankings debuted in 1984.