MINNEAPOLIS, Nov. 6 /PRNewswire-FirstCall/ -- ATS Medical, Inc. -- today announced that The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has completed an initial review of their premarket approval application (PMA) for the ATS 3f(R) Aortic Bioprosthesis Heart Valve. The FDA has indicated that the application is sufficiently complete to begin the substantive review process and is suitable for filing as of September 27, 2006.
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“We are pleased to announce the attainment of this important milestone along the path to US market approval of the ATS 3f(R) Aortic Bioprosthesis Heart Valve,” said Michael Dale, Chairman, President and CEO of ATS Medical. “The $700 million tissue heart valve market is the fastest growing segment within the $1.2 billion heart valve therapies marketplace. We believe that ATS 3f tissue heart valve technologies offer added value and therapeutic options for clinicians and patients, and we look forward to working closely with the FDA to bring these products to market.”
About ATS Medical
ATS Medical, Inc. provides innovative products and services focused on cardiac surgery. The company, global in scope, has been headquartered in Minneapolis, Minnesota since its founding in 1991. More than 130,000 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. The ATS 3f(R) brand encompasses multiple tissue heart valve product offerings at varying steps from market introductions to clinical trials to development projects that incorporate less invasive valve replacement technology. 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, SurgiFrost(R) and FrostByte(TM) products for surgical cryoablation of cardiac arrhythmias, RTI-Cardiovascular for allograft tissue services, and the development of PARSUS blood filtration technology. The ATS Medical web site is http://www.atsmedical.com.
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CONTACT: Michael Dale, President and CEO, +1-763-553-7736, or Mike Kramer,Senior Director of Finance, +1-763-557-2222, both of ATS Medical, Inc.; orInvestors: Jennifer Beugelmans, +1-646-277-8704, Doug Sherk,+1-415-896-6820, or Steve DiMattia, +1-646-277-8706 (Media)
Web site: http://www.atsmedical.com//
