Gore launches new type of study for Synecor hernia biomaterial

W.L. Gore & Associates said today it is launching a clinical quality improvement project to study its Synecor biomaterial designed for open, laparoscopic and robotic single-stage hernia repairs.

The Synecor biomaterial is comprised of dense monofilament polytetrafluoroethylene macroporous knit to provide strength and reduce bacteria growth, Gore’s Bio-A Web tissue scaffold and a non-porous PGA/TMC film to minimize tissue attachment at the visceral side, the company said.

The Flagstaff, Ariz.-based company said it partnered with patient safety organization Surgical Momentum to facilitate the study.

“We embarked on a CQI project in place of Gore’s historical approach to clinical studies to enable us to include a more representative patient sample and adapt to clinical findings in real time. The CQI framework allows the flexibility to implement changes to improve patient care throughout the evaluation period meaning improvements in quality, safety, satisfaction, cost and outcomes,” Gore general surgical products biz unit leader Ron Anderson said in a press release.

The new study will follow a “diverse” set of metrics including pre-operation health, operation details, post-operation health, short and long-term follow ups and costs, the company said.

“While there is certainly benefit to the traditional model of clinical studies, having the flexibility to adjust the project parameters as new information is uncovered is a benefit we need to take advantage of on these studies,” Surgical Momentum CEO Kevin Jackson said in a prepared statement.

Gore said that operating through a CQI rather than a standard clinical trial allows them “greater flexibility due to the absence of rigid guidelines and a lack of patient exclusion criteria,” saying it would allow for “more real world conditions to be more accurately represented.”

“I want to improve patient outcomes as quickly as possible, and the CQI model allows for that adaption at a much faster pace than traditional clinical studies,” Surgical Momentum founder and participating study physician Dr. Bruce Ramshaw said in prepared remarks.

In January, Gore said it won FDA 510(k) clearance for its Synecor biomaterial. Gore said the material will allow surgeons to get the benefits of both a permanent material and absorbable, non-permanent materials during hernia repairs.

While no certification is required to use the implant, Gore said it is providing operating room support and educational courses for surgeons interested in using the material.

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