FLAGSTAFF, Ariz. & BATON ROUGE, La.— APRIL 25, 2016 — W. L. Gore & Associates, Inc. (Gore) today announced the first successful implant of the GORE® SYNECOR Biomaterial. Karl A. LeBlanc, MD, FACS, used the unique material in a robotically-assisted hernia repair at Our Lady of the Lake Hospital, Baton Rouge, Louisiana. The GORE SYNECOR device received FDA approval in December 2015. This new, unique product combines two proven technologies – PTFE (polytetrafluoroethylene) and PGA/TMC (polyglycolic acid/trimethylene carbonate) bioabsorbable material – and offers surgeons a cost-effective, single-stage hernia repair device.
"I think that such a product represents the future in hernia repair," said Dr. LeBlanc. "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 GORE® SYNECOR device is being evaluated in a Clinical Quality Improvement (CQI) project designed to improve patient care. Hernia repair has traditionally required a surgeon to choose between a permanent material for a durable, single-stage repair, or absorbable, non-permanent materials where there are factors that may require a different approach. Providing a distinct alternative, GORE® SYNECOR Biomaterial is a unique, hybrid device comprised of:
- GORE® BIO-A® Web tissue-building scaffold for rapid vascularity and in-growth
- A macroporous knit of dense, monofilament PTFE fibers that provides optimum strength, and
- A nonporous PGA/TMC film that minimizes tissue attachment to the device on the visceral side.
Gore launched the clinical quality improvement (CQI) project as an alternative to a conventional clinical study to allow a broader patient sample and adapt to clinical findings in real time. Traditional clinical studies typically exclude certain patient types, limiting the ability for such studies to capture real world conditions. With a CQI project, there is greater flexibility due to the absence of rigid guidelines and a lack of patient exclusion criteria, all of which allows for more real-world conditions to be more accurately represented.
"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," said Michael Koenke, General Medical Products Global Leader at Gore. "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."
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.
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.
Gore products referenced within, if any, are used within their FDA approved/cleared indications. Gore does not have knowledge of the indications and FDA approval/clearance status of non-Gore products. Gore makes no representations as to the surgical techniques, medical conditions or other factors that may be described in the article(s). The reader is advised to contact the manufacturer for current and accurate information.