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www.fdanews.com/articles/71210-gore-receives-510-k-for-bioabsorbable-hernia-plug

Gore Receives 510(k) for Bioabsorbable Hernia Plug

April 18, 2005

W. L. Gore & Associates has received 510(k) clearance from the FDA to market the GORE Bioabsorbable Hernia Plug, an alternative to permanent hernia plugs.

The bioabsorbable properties of the device allow it to be completely absorbed naturally by the body as the hernia defect heals. Over 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 nonbioabsorbable plugs.

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 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.