W. L. Gore & Associates (Gore) announced that the US Food and Drug Administration (FDA) has given the company 510(k) clearance to market the GORE BIO-A Fistula Plug, the next generation of anal fistula repair. This new sphincter-preserving repair device combines a proven, synthetic bioabsorbable material with a patented design engineered to optimize operative success.
The innovative design of the GORE BIO-A Fistula Plug features bundled hollow tubes attached to a circular disk. The disk helps the plug stay in place, reducing the chance of a leading cause of fistula plug failure-the extrusion of the plug through the distal opening of the fistula tract. It also facilitates reproducible anchoring for dependable performance. The 3D structure of the tubes expands to fill the defect and facilitates rapid incorporation, helping to hold the device in place within the fistula. Surgeons are able to customize the GORE BIO-A Fistula Plug for most defects. Each tube can be trimmed or removed entirely, so the device conforms for a precise fit.
GORE BIO-A Fistula Plug is constructed with a proven, synthetic 100 percent bioabsorbable material – Polyglycolic Acid:Trimethylene Carbonate (PGA:TMC). The material is backed by 15 years of research and clinical use and has been successfully used to treat thousands of patients. It provides the patient’s body with a scaffold on which to build new tissue. Over time, as the patient begins to heal, this unique material is gradually absorbed by the body leaving no permanent material behind.
“Device dislodgement and degradation of the anal fistula plug by bacterial enzymes have accounted for some failures in the treatment of this condition in the past,” said Bradford Sklow, MD, Assistant Professor in the Department of Surgery at the University of Utah School of Medicine. “I believe the unique tube configuration of the GORE BIO-A Fistula Plug combined with a synthetic, bioabsorbable material presents an improvement in fistula plug design and may lead to more successful treatment outcomes.”
“Clinicians have been searching for an alternative to current methods, which have a disappointingly high failure rate,” said Ron Anderson, General Surgical Products Business Unit Leader at Gore. “The GORE BIO-A Fistula Plug has been engineered to offer a fundamentally new and reliable solution. This new device builds upon Gore’s heritage of innovation, high-performance technology and quality, which have enabled the company to create and bring to market many widely used products for surgical use.”
Source: W. L. Gore & Associates
published: May 6, 2009 in: Companies, Products, Regulatory, Specialty