ATS Medical Receives FDA Clearance for ATS Simulus Semi-Rigid Annulop...( Expands Heart Valve R...),Health

Expands Heart Valve Repair Product Portfolio

MINNEAPOLIS, Oct. 26 /PRNewswire-FirstCall/ -- ATS Medical, Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services, today announced U.S. Food and Drug Administration (FDA) clearance for the ATS Simulus(R) Semi-Rigid Annuloplasty Ring. These semi-rigid rings are the next in a series of mitral valve repair products developed and commercialized through the Company's partnership with Genesee BioMedical. This collaboration has worked closely with cardiac surgeons to create a semi-rigid ring with the unique Flex-Zone(TM) anterior segment. The ring respects the natural motion of the mitral annulus and its proximity to the aortic valve allowing for a safer, more physiologic valve repair. Annuloplasty rings and bands are used in those cases where repair of a patient's heart valve is preferable to replacement of the valve.

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Douglas Murphy, M.D. of St. Joseph's Hospital in Atlanta, Georgia, noted "I have utilized the original ATS Simulus(R) Flexible annuloplasty ring and band in hundreds of surgical cases and have been impressed with its superior handling and suturability. A semi-rigid version coupled with the variety of surgical repair techniques available will now allow us to further individualize and refine each patient's care with an eye towards continuous outcome improvement."

Michael Dale, President and CEO of ATS Medical commented, "The first results of our collaboration with Genesee BioMedical, ATS Simulus(R) Flexible rings and bands, were introduced
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