Healthcare Industry News: heart valve therapy
News Release - July 6, 2009
ATS Medical Announces FDA Clearance and First Implant of New ATS Simulus Semi-Rigid Annuloplasty BandExpands Heart Valve Repair Product Portfolio
MINNEAPOLIS, July 6 (Healthcare Sales & Marketing Network) -- ATS Medical, Inc. (Nasdaq: ATSI ), manufacturer and marketer of state-of-the-art cardiac surgery products and services, today announced FDA clearance and the first implant of the ATS Simulus® Semi-Rigid Annuloplasty Band. The Simulus Semi-Rigid Annuloplasty Band was developed through the Company's collaboration with Genesee BioMedical and represents the latest addition to the expanding portfolio of valve repair products.
Annuloplasty rings and bands are used in those cases where repair of a patient's heart valve is preferable to replacement of the valve. This new repair product has clinical applications that expand the existing therapeutic options for surgeons and their patients. The Simulus Semi-Rigid Band is specifically designed to respect the natural motion of the mitral annulus during the cardiac cycle allowing for a more physiologic valve repair. This unique characteristic can be particularly important in patients where both the aortic and mitral valves are being treated.
Dr. Robert F. Hebeler, Jr., who performed the first implant of the ATS Simulus Semi-Rigid Band at Heart Hospital Baylor in Plano, Texas commented, "This Simulus Semi-Rigid Band represents the next advancement in annuloplasty repair rings and provides an excellent option for my patients with mitral valve regurgitation. The band retains the natural saddle shape of the mitral valve annulus and preserves mobility during the cardiac phases, particularly in the aorto-mitral junction. These design characteristics make the Simulus Semi-Rigid Band easy to implant."
Michael Dale, President and CEO of ATS Medical added, "We are excited about the growth and innovation we have brought to the annuloplasty repair market. Our portfolio of Simulus annuloplasty products continues to be an important contribution to our heart valve therapy product platform."
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.
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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