Healthcare Industry News: cryoablation
News Release - April 10, 2008
ATS Medical Announces First North American Commercial Implant of the ATS 3f Aortic BioprosthesisFollows Canadian regulatory approval of the ATS 3f Valve
MINNEAPOLIS, April 10 (HSMN NewsFeed) -- ATS Medical, Inc. (Nasdaq: ATSI ), manufacturer and marketer of state-of-the-art cardiac surgery products and services, today announced the first North American commercial implant of the ATS 3f® Aortic Bioprosthesis. Canadian regulatory approval was received at the end of December, 2007. The first implant was performed by Benoit de Varennes, MD, MSc, FRSC, Chairman, Division of Cardiac Surgery at McGill University in Montreal, Canada. The patient was a 76-year-old man with aortic valve stenosis. The valve replacement was successful and the patient has been discharged from the hospital in good condition.
The ATS 3f Aortic Bioprosthesis incorporates revolutionary design concepts intended to preserve native aortic root geometry and function. Through this unique approach, the prosthesis more closely mimics native valve function providing excellent hemodynamic performance that may contribute to improvements in key determinants of cardiovascular performance such as coronary blood flow and left ventricular mass regression. Data suggests that physiologic stresses, a detriment to bioprosthetic valve longevity, may be more efficiently distributed throughout the prosthetic's leaflets.
"The ATS 3F valve incorporates important characteristics of many other valves all in one product. The hemodynamic characteristics are very good and the valve offers the potential for longer durability. Previous stentless valve designs appeared to have good hemodynamic performance, but complex implantation techniques made many surgeons reticent to use them widely. The ATS 3F valve requires a very simple technique to implant which is easy to reproduce and should lead to more patients benefiting from its many performance attributes," said Dr. de Varennes.
Michael Dale, President and CEO of ATS Medical commented, "Our first North American commercial implant is another milestone in our effort to broaden worldwide awareness and acceptance of the ATS 3f Aortic Bioprosthesis. ATS' first offering in the $730 million tissue valve market segment includes compelling differentiating features that can provide a better clinical solution for surgeons and patients alike. We are excited about the significant growth opportunities before us as we continue to expand the market introduction of our first tissue valve in combination with our other new product releases in heart valve therapy and the surgical treatment of atrial fibrillation."
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 145,000 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® annuloplasty products for heart valve repair and ATS CryoMaze(TM) surgical ablation products. 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, 2007.
Source: ATS Medical
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