W L Gore & Associates (Gore) has announced the first implant of the Gore Synecor Biomaterial in a robotically-assisted hernia repair at Our Lady of the Lake Hospital, Baton Rouge, Louisiana, US.
Approved by the US Food and Drug Administration (FDA) last year, the new medical device is based on polytetrafluoroethylene (PTFE) and polyglycolic acid / trimethylene carbonate (PGA/TMC) bioabsorbable material.
The hybrid device is composed of Gore Bio-A Web tissue-building scaffold for rapid vascularity and in-growth, a macroporous knit of dense, monofilament PTFE fibers to provide strength and a nonporous PGA/TMC film that reduces tissue attachment to the device on the visceral side.
It offers an alternative for hernia repair surgeons who earlier had to choose between a permanent material for a durable, single-stage repair, or absorbable, non-permanent materials.
FACS Dr Karl LeBlanc said: "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."
The device is being evaluated in Gore's clinical quality improvement (CQI), which is an alternate clinical study to allow a broader patient sample and adapt to clinical findings in real time.
Gore general medical products global leader Michael Koenke said: "Our ultimate objective with the CQI programme 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."
The surgeons will not require a pre-certification to implant Gore Synecor biomaterial. However, Gore offers operating room support and peer-to-peer educational courses for interested surgeons.
Image: Gore Synecor Biomaterial. Photo: courtesy of Business Wire.