Healthcare Industry News: mitral valve
News Release - August 22, 2007
ATS Medical Expands Open Pivot Heart Valve OfferingsMINNEAPOLIS, Aug. 22 (HSMN NewsFeed) -- ATS Medical, Inc. (Nasdaq: ATSI ), manufacturer and marketer of state-of-the-art cardiac surgery products and services, today announced that the US Food and Drug Administration (FDA) has granted the company approval to begin marketing additional sizes of its line of ATS Open Pivot® Mechanical Heart Valves.
Michael Dale, Chairman and Chief Executive Officer, noted, "We are pleased that our application to add the 25 and 35mm mitral valves to our US product offerings has been favorably reviewed and approved by FDA. Availability of these sizes will allow us to gain additional implants in accounts that we already serve, while improving our ability to compete for new business with a broader product offering. Extension of our mechanical valve product line has been an important objective in 2007. These approvals represent the first step towards meeting that goal, and we remain confident in our ability to bring additional planned mechanical valve product offerings to the US market."
About ATS Medical
ATS Medical, Inc. provides innovative products and services focused on cardiac surgery. The company, global in scope, is headquartered in Minneapolis, Minnesota. More than 135,000 ATS Open Pivot® 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® 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® and FrostByte® products for surgical cryoablation of cardiac arrhythmias, and RTI-Cardiovascular for allograft tissue services. 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, 2006 and its most recent quarterly report on Form 10-Q.
Source: ATS Medical
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