W.L. Gore and Associates announced the first successful implant of iSynecor Biomaterial for hernia repair.
Karl A. LeBlanc, MD, used the material in a robotically-assisted hernia repair at Our Lady of the Lake Hospital, Baton Rouge, LA.
The Synecor device received FDA approval in December 2015. This product combines proven technologies – Gore’s PTFE (polytetrafluoroethylene) and PGA/TMC (polyglycolic acid/trimethylene carbonate) bioabsorbable material.
“I think that such a product represents the future in hernia repair,” said 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 device 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. Syecor provides both features.
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, a Gore release stated.
“Our ultimate objective with the CQI program is to evaluate how to make hernia repair using Gore Synecor S 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. For more visit www.goremedical.com.
Gore Medical is based in Flagstaff, AZ. and has production sites in Arizona. Gore is headquartered in Newark. Over a 40-year period, 40 million Gore devices have been implanted in hernia repair, cardiac treatment and other areas.
