FLAGSTAFF, Ariz. – October 23, 2017 – Physicians among the first to use the GORE® SYNECOR Preperitoneal Biomaterial, a unique hybrid device for hernia repair, are reporting positive experiences in using the device in a range of applications, according to W. L. Gore & Associates (Gore). The company today shared feedback from physicians focused on bariatric, hernia, and plastic surgery who have used the GORE® SYNECOR Preperitoneal Biomaterial hernia repair device since it received 510(k) clearance from the Food and Drug Administration in June.
GORE SYNECOR Preperitoneal Biomaterial was designed to provide high strength with rapid tissue ingrowth on both sides in a single device, and is ideal for procedures requiring both of those benefits and for techniques such as transversus abdominis muscle release (TAR).
“The ability to do a procedure once and be confident it won’t require reintervention is especially crucial in complex procedures like TAR. Once the muscle layers have been dissected, any recurrence or reoperation becomes riskier and more difficult,” said Marcos Michelotti, MD, FACS, Loma Linda University Medical Center, who used GORE SYNECOR Preperitoneal Biomaterial in a recent TAR procedure. Dr. Michelotti has also used the device in an onlay procedure to repair a hernia caused when a trocar was inserted to perform a sleeve gastrectomy. “The new Gore device allows for a single-stage repair even in complex cases. It handles well and is extremely durable. I asked my two residents to try to tear the leftover material in half, and they couldn’t -- even at the edges. I’m very pleased my hospital is adding this new device to our current GORE SYNECOR Biomaterial consignment.”
The hybrid, biosynthetic hernia repair solution is intended for single-stage preperitoneal, onlay, and retromuscular placements through open, laparoscopic, and robotic applications. It is comprised of three layers: A macroporous knit of dense, monofilament polytetrafluoroethylene (PTFE) fibers provides strength for a durable single-stage repair and is designed to minimize harboring of bacteria, while two surrounding layers of GORE® BIO-A® Web, a bioabsorbable copolymer scaffold, facilitate tissue ingrowth and vascularization on both sides of the device. The GORE BIO-A Web 3-D scaffold of interconnected pores fills quickly with collagen and facilitates 1:1 tissue generation within the thickness of the material, with complete absorption by the body in about six months. The combination of strong permanent synthetic mesh with a bioabsorbable scaffold minimizes remaining material and may reduce common complications such as hernia recurrence and mesh splitting to improve patient quality of life.
Common applications for this device, besides TAR, include other component separation techniques, preperitoneal ventral hernia repair, and high-risk ventral hernia repair. For additional detail, visit goremedical.com/synecorpre.
Garth R. Jacobsen, MD, FACS, UC San Diego Health, closed an open ventral hernia using GORE SYNECOR Preperitoneal Biomaterial. “Suturing through the mesh was easy,” he said. William S. Cobb IV, MD, FACS, Greenville Memorial Hospital, commented on the value of the potential of the device to reduce complications even in complex cases. Dr. Cobb used the device as an abdominal reinforcement with the Rives-Stoppa technique in a patient who required removal of recurrent endometriomas and part of the abdominal wall with them. Given the potential risk of wound complications, Dr. Cobb decided to utilize the hybrid GORE SYNECOR Preperitoneal Biomaterial.
Gore’s hernia repair product portfolio includes treatment options for the full range of hernia cases and also includes GORE® SYNECOR Intraperitoneal Biomaterial, a three-layer hernia device that features GORE BIO-A Web on one side, PTFE knit in the middle, and a nonporous film to minimize visceral attachment when placed directly against the bowels.1 It has been evaluated through a post-market Clinical Quality Improvement (CQI) Study designed to evaluate the real-world use of the device without exclusion criteria. GORE BIO-A Web, which is a component of the GORE SYNECOR Biomaterial products, is also available in the fully bioabsorbable GORE® BIO-A® Tissue Reinforcement for soft tissue reinforcement procedures.
1. For Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU) and / or goremedical.com.