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ATS Medical Announces Receipt of CE Mark for the New ATS CryoMaze 10-S Probe

October 13, 2009

MINNEAPOLIS, Oct. 13 /PRNewswire-FirstCall/ — ATS Medical, Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services, today announced the receipt of CE Mark for the ATS CryoMaze® 10-S Surgical Cryoablation Probe for the treatment of cardiac arrhythmias. The first use of the 10-S probe in Europe was performed by Professor Friedrich W. Mohr at the Klinik fur Herzchirurgie (Clinic for Heart Surgery) in Leipzig, Germany. Professor Mohr is a globally renowned thought leader within the cardiac surgery community.

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The ATS CryoMaze 10-S Probe complements the current product offering by adding a linear cryoablation probe that provides more controlled stiffness than the current ATS CryoMaze Probes. The increased support throughout the length of the 10-S probe addresses the preference of some surgeons to have more probe leverage to achieve contact with targeted tissue that is difficult to reach. In addition, the controlled support of the ATS CryoMaze 10-S Probe will optimize the shape retention of the malleable probe which is particularly useful in minimally invasive procedures.

“I have been using the ATS CryoMaze system for several years,” said Professor Mohr. “I now prefer the 10-S probe because I believe it will be useful to help me maintain good tissue contact, especially in minimally invasive procedures.”

The new cryoablation probe leverages the second generation, Argon-based ATS CryoMaze System that quickly achieves the coldest probe temperatures available for cardiac arrhythmia surgery. The Argon- based cryoablation system routinely reaches probe temperatures of -160 degrees Celsius compared to nitrous-oxide systems that only reach temperatures of -65 degrees Celsius. The colder probe temperatures provide faster, deeper lesions yielding greater confidence that transmural, linear lesions are being achieved, especially in clinical situations in which varying tissue thickness is the rule.

The proprietary design utilized in all ATS CryoMaze Probes allows them to be easily shaped by hand without the need for a tool to control the radius of the bends. The probe can be repeatedly re-shaped to meet the different anatomic requirements of the individual patient and procedure. The “bellows” design of the ATS CryoMaze Probes facilitates this durable probe malleability without kinking and/or fractures.

“The development of the ATS CryoMaze 10-S Probe was our response to requests from cardiac arrhythmia surgeons for a more substantial cryoablation instrument. This is one more example of our commitment to be responsive to the needs of our cardiac surgeon customers all around the world,” said Michael Dale, President and CEO of ATS Medical.

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® 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® 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® 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® 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 for surgical cryoablation of cardiac arrhythmias. ATS CryoMaze(TM) products are used by surgeons to treat patients suffering from cardiac arrhythmias, the largest and fastest growing form of structural heart disease in populations over 60 years of age. The ATS Medical web site is http://www.atsmedical.com.

Safe Harbor

This Press Release contains forward-looking statements that may include statements regarding intent, belief or current expectations of the Company and its management. Actual results could differ materially from those projected in the forward-looking statements as a result of a number of important factors, including the results of clinical trials, the timing of regulatory approvals, the integration of 3f Therapeutics and the surgical cryoablation business of CryoCath Technologies, Inc., regulatory actions, competition, pricing pressures, supplier actions and management of growth. For a discussion of these and other risks and uncertainties that could affect the Company’s activities and results, please refer to the Company’s filings with the Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2008 and its most recent quarterly report on Form 10-Q.

SOURCE ATS Medical, Inc.


Source: newswire