EU approves ATS Medicals aortic bioprosthesis valve

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ATS Medical has received CE Mark approval to distribute its ATS 3f Enable aortic bioprosthesis valve in the European Union.

The Minneapolis-based company said its Enable valve is designed for surgical aortic valve replacement that is implanted using a sutureless technique. The platform combines the 3f tubular pericardial valve design with its hemodynamic profiles and a self-expanding frame to hold the valve in its optimal position.

According to ATS, commercialization of the Enable valve will commence with a controlled market release at select surgical centers in Europe, and release of the second-generation Enable is expected in the latter half of 2010.