ATS Medical Provides Update on US Commercialization of Its ATS 3f Aortic Bio...( MINNEAPOLIS Dec. 8 /- ATS Medical Inc...)

MINNEAPOLIS, Dec. 8 /PRNewswire-FirstCall/ -- ATS Medical, Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services, today announced it has received FDA clearance for the marketing of the ATS 3f(R) Aortic Bioprosthesis that includes a new sewing tab material supplier and an improved valve holder accessory device.

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While the ATS 3f Aortic Bioprosthesis PMA was approved on October 30, 2008, as previously indicated, a full commercial launch would commence in the first quarter of 2009 once these milestones were achieved. ATS Medical has achieved these milestones and is on track with the previous guidance. The ATS 3f Aortic Bioprosthesis is the Company's first entry into the $400-plus million U.S. tissue valve market.

"The FDA clearance was necessary for ATS Medical to commence a full commercial launch of our first tissue valve in the US. We are excited to achieve these important milestones for the Company," said Michael Dale, President and Chief Executive Officer of ATS Medical. "The tissue valve market presents the largest market opportunity for our Company and will importantly provide ATS Medical the leverage it needs to sustain high growth and enhanced profitability in the future."

Based on the precept that 'Form Follows Function', the ATS 3f Aortic Bioprosthesis is a revolutionary next generation stentless pericardial aortic tissue valve that is unlike any other valve. The tubular design of the ATS 3f Aortic Bioprosthesis maintains the continuity of the annulus and the sino tubular junction. No other valve mimics the native valve in this manner. By maintaining this continuity, the ATS 3f Aortic Bioprosthes
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