MINNEAPOLIS, March 28 /PRNewswire-FirstCall/ -- ATS Medical, Inc. today reported that it has submitted its Investigational Device Exemption for the ATS 3f Enable(TM) Aortic Bioprosthesis to the FDA for review and approval. This is the next step in the process necessary to begin clinical trials in the United States.
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The ATS 3f Enable Aortic Bioprosthesis is targeted to be the companies’ second tissue valve product to market. This revolutionary first of its kind prosthesis is designed to eliminate the cardiac surgeon’s meticulous and time consuming procedure of placing and tying the 12-20 or more sutures necessary to implant current valve replacements. A flexible Nitinol frame has been integrated with the companies’ initial tissue valve offering, the ATS 3f(R) Aortic Bioprosthesis. During an open chest procedure and after removal of the diseased valve, the ATS 3f Enable Aortic Bioprosthesis is folded into a reduced geometry and diameter that is positioned in the native valve annulus with a proprietary delivery system. Upon deployment, the Nitinol frame and valve expand within the annulus applying a continuous radial force that effectively implants the valve without the need for sutures. Overall procedure time and specifically, cardio-pulmonary bypass time can be significantly reduced.
Michael Dale, President and CEO of ATS noted, “The ATS 3f Enable Aortic Bioprosthesis portends compelling advances to the aortic valve replacement procedure for surgeons and patients. More rapid and reliable implantation of a hemodynamically efficient prosthesis stands to significantly reduce the patient’s operative and long term risk profile. We are excited for the opportunity to begin clinical trials in the United States and build upon our early implant experience in Europe.”
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. More than 135,000 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 .
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, 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, 2006.
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CONTACT: Michael Dale, President-CEO, +1-763-553-7736, or Michael Kramer,Senior Director of Finance, +1-763-557-2222, or Investors, JenniferBeugelmans, +1-646-201-5447, or Doug Sherk, +1-415-896-6820, SteveDiMattia, +1-646-201-5445 (Media), for ATS Medical, Inc.
Web site: http://www.atsmedical.com/
