Healthcare Industry News:  cryoablation 

Devices Cardiology

 News Release - April 20, 2010

ATS Medical Announces First Implant of ATS 3f Aortic Bioprosthesis in China

Permission to Market Granted by Chinese SFDA

MINNEAPOLIS, April 20 (Healthcare Sales & Marketing Network) -- ATS Medical, Inc. (Nasdaq:ATSI ), manufacturer and marketer of state-of-the-art cardiac surgery products and services today announced the first commercial implant of the ATS 3f® Aortic Bioprosthesis was recently completed by Liu Zhi Gang, MD at Fu Wai Hospital in Beijing, China. Fu Wai Hospital is the largest cardiac surgery center in Asia and a full line of ATS products are utilized by their surgeons. ATS received permission from the Chinese State Food and Drug Administration (SFDA) to market the ATS 3f Aortic Bioprosthesis in March.

As part of the launch effort in China, Mr. Kulvinder Lall served as a proctor during the first case and facilitated hands-on training for a number of other surgeons. Mr. Lall is a Consultant Cardiothoracic Surgeon at the Royal Hospital of St. Bartholomew in London, England who has been implanting the ATS 3f Aortic Bioprosthesis since 2006.

"The ATS 3f Aortic Bioprosthesis is much easier to implant than other stentless valves. This is especially important in the small sizes," stated Dr. Liu. A size 23 mm 3f Aortic Bioprosthesis was implanted with a resulting mean pressure gradient of 5 mmHg, which is considered an excellent hemodynamic performance for the smaller size aortic annulus.

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. It is designed to function just like a native valve. Its tubular design was inspired by how a native valve forms in utero: as a tube with sides that collapse when external pressure is applied. The primary benefit of the ATS 3f Aortic Bioprosthesis is that it restores physiologic, non-turbulent blood flow and native-like stress distribution to the aortic root. This valve provides surgeons and patients a potentially more durable solution to aortic valve replacement.

"The first ATS 3f Aortic Bioprosthesis implant at Fu Wai Hospital was a great success. I believe that the ease of implantation and excellent haemodynamics, especially in the small aortas, makes this an ideal valve for the Chinese population," stated Mr. Lall.

"We are excited to expand our product portfolio in China to include the ATS 3f Aortic Bioprosthesis. The tissue valve market in China nearly doubled in 2009 and is expected to continue this rapid growth. China represents a significant portion of ATS Medical's current revenue in 2009 and is one of the most important growth markets in the world," stated 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 ATS 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® products for surgical cryoablation of cardiac arrhythmias. ATS CryoMaze® 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.

Cautionary Statements

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 impact of pending healthcare reforms, 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, 2009 and its most recent quarterly report on Form 10-Q.


Source: ATS Medical

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