FLAGSTAFF, AZ (April 14, 2005) - W. L. Gore & Associates, Inc. (Gore) has received 510(k) clearance from the U.S. Food and Drug Administration to market the GORE Bioabsorbable Hernia Plug. The device, the first of its kind, was developed as an alternative to permanent hernia plugs.
The unique bioabsorbable properties of the device allow it to be completely absorbed naturally by the body as the hernia defect heals. "Over a time span of approximately six months, the GORE Bioabsorbable Hernia Plug will literally disappear from the body and reduce the potential for chronic complications that have been associated with some non-bioabsorbable plugs," said William Montgomery, Gore Product Specialist. "The possibility of ongoing patient discomfort and reintervention associated with permanent plugs is lowered." The new product is a result of Gore's 15 years of research in bioasorbables, added Montgomery.
The GORE Bioabsorbable Hernia Plug's design optimizes repair time, while allowing the surgeon to quickly and easily tailor the device to fit the defect. The extremely flexible, hollow tubes unique to the GORE Bioabsorbable Hernia Plug fold and collapse, permitting the device to adapt to the cavity. Excess material can be trimmed away, further enhancing tailorability. In addition, the tubular construction serves as scaffolding for guided tissue regeneration.
The GORE Bioabsorbable Hernia Plug is available with or without a permanent overlay mesh.
ABOUT W. L. GORE & ASSOCIATES, INC.
The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for 30 years. During that time, more than 12 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, and sutures for use in vascular, cardiac, general surgery and orthopedic procedures.
Products listed may not be available in all markets pending regulatory clearance.
GORE is a trademark of W. L. Gore & Associates.
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W. L. Gore & Associates, Inc.
800-528-8763
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