MINNEAPOLIS, Aug. 27 ATS Medical, Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services, announced today that the FDA has approved a landmark clinical study in which cardiac surgeons will implant the ATS 3f(R) Aortic Bioprosthesis in a younger aortic valve replacement patient population that has not been previously studied in a controlled and scientific manner.
This new FDA approved clinical study will enroll patients younger than 60 years of age, with half of the population younger than 50 years of age. The Company believes that this study will ultimately demonstrate the excellent safety, efficacy and durability of the ATS 3f Aortic Bioprosthesis in this new patient population, while illustrating the performance necessary to maintain the active lifestyle of the younger population.
The ATS 3f Aortic Bioprosthesis is an aortic valve 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 its tubular design and that it restores physiologic non turbulent blood flow and native-like stress distribution to the aortic root. This valve design provides surgeons and patients with a potentially more durable solution to aortic valve replacement.
ATS Medical is working diligently on hospital selection and patient enrollment will commence immediately after Institutional Review Board approval has been granted at each site. "We are encouraged by the FDA approval to pursue this landmark opportunity in an approved post-market study with the ATS 3f Aortic Bioprosthesis in a younger patient population. We look forward to the outcomes that will demonstrate scientifically that the ATS 3f Aortic Bioprothesis is the highest performing tissue valve available to all patients in need of aortic valve replacement," said Astrid Berthe, Vice President of Regulatory Affairs.
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.
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.