Healthcare Industry News:  cryoablation 

Devices Cardiology

 News Release - September 21, 2009

ATS Medical Announces Implant Milestone for the ATS 3f Aortic Bioprosthesis Achieved at Columbia University Medical Center

MINNEAPOLIS, Sept. 21 (Healthcare Sales & Marketing Network) -- ATS Medical, Inc. (Nasdaq: ATSI ), manufacturer and marketer of state-of-the-art cardiac surgery products and services, today announced that Columbia University Medical Center has achieved 100 implants of the ATS 3f® Aortic Bioprosthesis. 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 Columbia University surgeons have utilized the ATS 3f Aortic Bioprosthesis predominantly in small aortic roots where conventional stented tissue valves lack a pronounced hemodynamic benefit. These surgeons are also pioneering applications of the ATS 3f Aortic Bioprosthesis including use of the ATS 3f valve together with a synthetic aortic graft containing the sinuses of valsalva for full root replacement. Columbia University Medical Center is the leading ATS Center of Excellence for surgical training, clinical trial enrollment, and demonstration of the clinical benefit for patients receiving the ATS 3f valve using the principles of evidence based medicine.

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

"The design of the ATS 3f valve is unique and may improve longevity by providing normal sinus function allowing the swirling effect of the blood to close the valve under low pressure. There is no bulky stent to impede the outflow of blood from the heart during systolic contraction. The result is the excellent hemodynamic performance of the ATS 3f valve that we have documented at Columbia," stated Allan Stewart, MD.

"We are gratified that the experience with the ATS 3f Aortic Bioprosthesis at Columbia University Medical Center demonstrates the excellent performance and strong safety profile of this valve. Growing numbers of surgeons around the world are achieving similar results," 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 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

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