Gore touts 1st implant of Synecor in CQI trial

W.L. Gore & Associates said today its Synecor biomaterial designed for hernia repair was used in the 1st procedure of its clinical quality improvement project.

The robotically assisted surgical procedure was performed at the Our Lady of the Lake hospital in Baton Rouge, La. by Dr. Karl LeBlanc, the Newark, Del.-based company said.

“I think that such a product represents the future in hernia repair. The combination of a permanent material with the absorbable portion is intended to increase ingrowth, strengthen the repair, and allow for lower recurrence rates in the process. And, the product handles quite nicely – it has just the right amount of stiffness to make its use with the laparoscope or robot very easy,” Dr. LeBlanc said in a press release.

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.

“Our ultimate objective with the CQI program is to evaluate how to make hernia repair using Gore Synecor Biomaterial as successful as possible in regards to both the physician experience and patient outcomes. Even in our first case with Dr. LeBlanc, we have already been able to gain insight and analyze various factors that will lead to better patient outcomes in the immediate future,” Gore general medical products global leader Michael Koenke said in prepared remarks.

In March, Gore said it launched a clinical quality improvement project to study its Synecor biomaterial designed for open, laparoscopic and robotic single-stage hernia repairs.

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.

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.”

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.

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