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ATS Medical Announces FDA Approval for a Landmark Clinical Investigation of the ATS 3f Aortic Bioprosthesis
Date:8/27/2009

at each site. "We are encouraged by the FDA approval to pursue this landmark opportunity in an approved post-market study with the ATS 3f Aortic Bioprosthesis in a younger patient population. We look forward to the outcomes that will demonstrate scientifically that the ATS 3f Aortic Bioprothesis is the highest performing tissue valve available to all patients in need of aortic valve replacement," said Astrid Berthe, Vice President of Regulatory Affairs.

About ATS Medical

ATS Medical, Inc. is dedicated to 'Advancing The Standards' of cardiac surgery through the development, manufacturing and marketing of innovative products and services for the treatment of structural heart disease. ATS Medical serves the cardiac surgery community by focusing on two distinct but operationally synergistic market segments: heart valve disease therapy and surgical ablation of cardiac arrhythmias.

ATS was originally founded to develop the ATS Open Pivot(R) Heart Valve as a new mechanical heart valve standard of care. Today the Open Pivot heart valve is the preferred mechanical heart valve in many markets around the world and the fastest growing mechanical prosthesis in the market. Building on this legacy and addressing the largest market segment in heart valve therapy, the ATS 3f(R) brand encompasses an innovative tissue heart valve portfolio to address conventional open surgery requirements as well as the growing demand for less invasive sutureless based procedures. The ATS 3f(R) portfolio includes offerings at various stages including early product development, pivotal clinical trials, and market commercialization. Completing the portfolio in heart valve therapy is the ATS Simulus(R) annuloplasty product line. Simulus products assist the surgeon in repairing a patient's native heart valve as an alternative to replacement. Continuing ATS Medical's focus on serving the cardiac surgery community are the ATS CryoMaze(TM) products
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SOURCE ATS Medical, Inc.
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