TYRX FILES FDA 510(K) FOR NEW SURGICAL MESH

TyRx Pharma has filed a 510(k) application with the FDA for its new bioresorbable polymer coated surgical mesh product.

TyRx's mesh is indicated for the repair of hernias and other abdominal fascial or muscular deficiencies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. The firms said it expects to launch the product during the first quarter of 2006.

The mesh is the first in a series of combination medical products that TyRx expects to market next year, the company said. TyRx is also focused on developing a family of proprietary bioresorbable drug-eluting polymers for use in combination medical devices and specialty pharmaceuticals. As part of that effort, thee company is working with Boston Scientific to develop novel drug-eluting coatings for cardiovascular stents.