FDA News

FDA Approves ATS Medical's AP360 Mechanical Heart Valve

(Dec 18, 2007)-- ATS Medical, manufacturer and marketer of state-of-the-art cardiac surgery products and services, today announced U.S. Food and Drug Administration (FDA) approval for the ATS Open Pivot(R) AP360(TM) Mechanical Heart Valve.

The ATS AP360 heart valve maximizes hemodynamic performance with a new supra-annular cuff design that facilitates implantation. The original ATS Medical Open Pivot Heart Valve is highly regarded for fundamental design features that promote best-in-class hemodynamic performance, enhanced resistance to blood clot formation and improved patient quality of life through quieter valve operation. In a response to the highly individualized and specific valve selection criteria of cardiac surgeons, particularly with respect to implantability, the ATS AP360 combines proven performance with a cuff design that extends its appeal to a broader spectrum of surgeons.

Michael Dale, President and CEO of ATS Medical commented, "Heart valve sewing cuff material and design contribute to the ease with which suturing needles pass through the cuff and an uncomplicated positioning of the valve at the implant site. Surgeons develop a feel for, and gain confidence and comfort in a cuff that is well suited to their individual surgical techniques. When it comes to sewing cuffs, one style does not fit all tastes. Our AP360 combines AP's superior hemodynamic performance with a new cuff design that will better suit the requirements of a significant additional segment of surgeons. The AP360 will allow us to reapproach those who have been intrigued by the ATS Open Pivot Heart Valve story but have desired a cuff more compatible with their preferences. We believe that this important expansion of our mechanical heart valve line will have a positive impact on growth in this product category, and move us closer to our goal of profitability in 2008. This approval is yet another milestone in our strategy to successfully bring innovative products to market as we continue to develop our large and growing research and development pipeline."

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