Healthcare Industry News: cryoablation
News Release - December 18, 2007
ATS Medical Receives FDA Approval for AP360 Mechanical Heart ValveValve Offers Superior Hemodynamic and Implantability Characteristics
MINNEAPOLIS, Dec. 18 (HSMN NewsFeed) -- ATS Medical, Inc. (Nasdaq: ATSI ), manufacturer and marketer of state-of-the-art cardiac surgery products and services, today announced U.S. Food and Drug Administration (FDA) approval for the ATS Open Pivot® AP360(TM) Mechanical Heart Valve.
The ATS AP360 heart valve maximizes hemodynamic performance with a new supra-annular cuff design that facilitates implantation. The original ATS Medical Open Pivot® Heart Valve is highly regarded for fundamental design features that promote best-in-class hemodynamic performance, enhanced resistance to blood clot formation and improved patient quality of life through quieter valve operation. In a response to the highly individualized and specific valve selection criteria of cardiac surgeons, particularly with respect to implantability, the ATS AP360 combines proven performance with a cuff design that extends its appeal to a broader spectrum of surgeons.
Michael Dale, President and CEO of ATS Medical commented, "Heart valve sewing cuff material and design contribute to the ease with which suturing needles pass through the cuff and an uncomplicated positioning of the valve at the implant site. Surgeons develop a feel for, and gain confidence and comfort in a cuff that is well suited to their individual surgical techniques. When it comes to sewing cuffs, one style does not fit all tastes. Our AP360 combines AP's superior hemodynamic performance with a new cuff design that will better suit the requirements of a significant additional segment of surgeons. The AP360 will allow us to reapproach those who have been intrigued by the ATS Open Pivot® Heart Valve story but have desired a cuff more compatible with their preferences. We believe that this important expansion of our mechanical heart valve line will have a positive impact on growth in this product category, and move us closer to our goal of profitability in 2008. This approval is yet another milestone in our strategy to successfully bring innovative products to market as we continue to develop our large and growing research and development pipeline."
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 140,000 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, ATS CryoMaze(TM) surgical ablation products, 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
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.