MINNEAPOLIS, July 31 /PRNewswire-FirstCall/ -- ATS Medical, Inc. today announced the new ATS Open Pivot(R) AP360(TM) Mechanical Heart Valve has received CE approval for marketing and use in Europe, indicating its compliance with relevant European health, safety and environmental protection legislation.
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ATS Medical President, CEO and Chairman of the Board Michael D. Dale said, “Surgeons have highly individualized and specific preferences regarding valve selection criteria, particularly with respect to implantability. With the ATS Open Pivot AP360 Heart Valve we have expanded on the fundamental strengths of the open pivot design. We have maximized hemodynamic performance while creating a cuff design that will extend our appeal to a broader spectrum of surgeons. We are excited to announce this next step in our plan to bring the open pivot design and performance to a larger worldwide audience of patients and surgeons.”
The ATS Open Pivot AP360 Heart Valve allows for a number of design enhancements that lead to particularly outstanding performance in all areas considered important to valve selection: implantability, hemodynamics, thromboresistance, durability and patient quality of life. It is based on the proven clinical foundation of the ATS Open Pivot Heart Valve that has been implanted in patients for more than 14 years. The ATS Open Pivot AP360 Heart Valve utilizes the same open pivot design which has no recesses or cavities to promote formation of thrombus and incorporates a strengthening band of MP35N, a cobalt-chrome alloy, providing exceptional compressive strength and durability. The flexible, flanged polyester cuff provides improved suturability, flexibility and conformability, making even the most challenging implant easier.
About ATS Medical
ATS Medical, Inc. manufactures and markets products and services focused on cardiac surgery. The company, global in scope, has been headquartered in Minneapolis since its founding in 1991. More than 100,000 ATS Open Pivot(R) Heart Valves, which utilize a unique pivot design resulting in exceptional performance and low risk profile, have been implanted in patients worldwide. ATS Medical’s focus on serving the cardiac surgery community is further strengthened by offerings that include ATS Simulus(TM) annuloplasty products for heart valve repair, Surgi-Frost(R) and Frost-Byte(TM) products for surgical cryoablation of cardiac arrhythmias, RTI-Cardiovascular for allograft tissue services, QAS home monitoring services for anticoagulation therapy and the development of PARSUS blood filtration technology. 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 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, 2005, as amended.
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CONTACT: Michael Dale, President and CEO, +1-763-557-2224, or Investors,Jennifer Beugelmans, +1-646-277-8704, or Doug Sherk, +1-415-896-6820, orSteve DiMattia, +1-646-277-8706 (Media), all of ATS Medical, Inc.
Web site: http://www.atsmedical.com/
