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Last updated on April 24, 2014 at 6:16 EDT

ATS Medical Announces FDA Clearance of the ATS Simulus Adjustable Annuloplasty Band

May 12, 2009

Expands Heart Valve Repair Product Portfolio

MINNEAPOLIS, May 12 /PRNewswire-FirstCall/ — ATS Medical, Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services, today announced FDA clearance of the ATS Simulus(R) Adjustable Annuloplasty Band.

(Logo: http://www.newscom.com/cgi-bin/prnh/20040202/ATSILOGO)

The ATS Simulus Adjustable Annuloplasty Band is the next product in a portfolio of mitral valve repair products developed and commercialized through the Company’s partnership with Genesee BioMedical.

This band respects the natural motion of the mitral annulus and its proximity to the aortic valve allowing for a safe, physiologic valve repair. The simple but elegant design of the ATS Simulus Adjustable Band allows the surgeon to make asymmetric or symmetric adjustments to the posterior segment of the mitral valve annulus at any time during the procedure, optimizing the repair. This product is also indicated for tricuspid valve repair, where a band is the preferred annuloplasty device.

Annuloplasty rings and bands are used in those cases where repair of a patient’s heart valve is preferable to replacement of the valve. The ATS Simulus Adjustable Band provides additional options for surgeons in terms of different exposures, double valve procedures and minimally invasive implants.

This Simulus Adjustable Band is another product developed as a result of the collaboration between ATS and Genesee Biomedical. John Wright, PhD, CEO of GBI has been involved in heart valves and valve repair therapy for more than 25 years. Dr Wright’s depth of experience has contributed significantly to the enormous growth of the Simulus product line.

Michael Dale, President and CEO of ATS Medical commented: “Our valve repair business continues to grow and build momentum. We have expanded our repair platform by adding offerings in the flexible and semi-rigid segments. The breadth of our portfolio will enable more choices for our surgeon customers to accommodate their clinical needs and that of their patients, thus bolstering our growth prospects.”

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 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