Healthcare Industry News:  mitral valve 

Devices Cardiology Regulatory

 News Release - March 22, 2010

ATS Medical Receives Approval to Commercialize the ATS Simulus Annuloplasty Products in Canada

Products will be introduced by New Canadian Distribution Partner

MINNEAPOLIS, March 22 (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 Health Canada-Medical Device Bureau, Therapeutic Products Programme has approved commercialization of the ATS Simulus® Annuloplasty Product Line for valve repair.

The Simulus product portfolio includes flexible, semi-rigid and adjustable annuloplasty rings and bands for use in mitral and tricuspid valve repair. Valve repair, as opposed to valve replacement, has been established as the gold standard of therapy for diseased or damaged mitral valves. Simulus annuloplasty products are unique in that they are designed to provide physiologic support for the repaired valve, adapting to the natural movement of the heart in the cardiac cycle. In addition, the Simulus product line provides excellent handling characteristics that are recognized and appreciated by cardiac surgeons.

This approval expands the growth opportunity for ATS Medical in Canada and is further complemented by the addition of a new distribution partner, Canadian Hospital Specialties, Limited. This privately owned firm has established a significant base of business in the healthcare market throughout Canada. They have formed a new cardiac surgery division and have added three experienced cardiac surgery specialists focused on driving the adoption of the ATS product portfolio.

"ATS looks forward to collaboration with Canadian Hospital Specialties to introduce the ATS Simulus product line to the Canadian surgical community," stated Michael Dale, President and CEO of ATS Medical. "This new partnership will allow us reach key opinion leaders in cardiac surgery and more fully penetrate the Canadian marketplace," he concluded.

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.


Source: ATS Medical

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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