MINNEAPOLIS, Dec. 18 ATS Medical, Inc.(Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgeryproducts and services, today announced U.S. Food and Drug Administration (FDA)approval for the ATS Open Pivot(R) AP360(TM) Mechanical Heart Valve.
The ATS AP360 heart valve maximizes hemodynamic performance with a newsupra-annular cuff design that facilitates implantation. The original ATSMedical Open Pivot(R) Heart Valve is highly regarded for fundamental designfeatures that promote best-in-class hemodynamic performance, enhancedresistance to blood clot formation and improved patient quality of lifethrough quieter valve operation. In a response to the highly individualizedand specific valve selection criteria of cardiac surgeons, particularly withrespect to implantability, the ATS AP360 combines proven performance with acuff design that extends its appeal to a broader spectrum of surgeons.
Michael Dale, President and CEO of ATS Medical commented, "Heart valvesewing cuff material and design contribute to the ease with which suturingneedles pass through the cuff and an uncomplicated positioning of the valve atthe implant site. Surgeons develop a feel for, and gain confidence andcomfort 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 AP360combines AP's superior hemodynamic performance with a new cuff design thatwill better suit the requirements of a significant additional segment ofsurgeons. The AP360 will allow us to reapproach those who have been intriguedby the ATS Open Pivot(R) Heart Valve story but have desired a cuff morecompatible with their preferences. We believe that this important expansionof our mechanical heart valve line will have a positive impact on growth inthis product category, and move us closer to our goal of profitability in2008. This approval is yet another milestone in our strategy to successfullybring innovative products to market as we continue to develop our large andgrowing research and development pipeline."
About ATS Medical
ATS Medical, Inc. provides innovative products and services focused oncardiac surgery. The company, global in scope, is headquartered inMinneapolis, Minnesota. More than 140,000 ATS Open Pivot(R) Heart Valves,which utilize a unique pivot design resulting in exceptional performance andlow risk profile, have been implanted in patients worldwide. The ATS 3f(R)brand encompasses multiple tissue heart valve product offerings at varyingsteps from market introductions to clinical trials to development projectsthat incorporate less invasive valve replacement technology. ATS Medical'sfocus on serving the cardiac surgery community is further strengthened byofferings that include ATS Simulus(R) annuloplasty products for heart valverepair, ATS CryoMaze(TM) surgical ablation products, and RTI-Cardiovascularfor allograft tissue services. The ATS Medical web site ishttp://www.atsmedical.com.
This Press Release contains forward-looking statements that may includestatements regarding intent, belief or current expectations of the Company andits management. Actual results could differ materially from those projectedin the forward looking statements as a result of a number of importantfactors, including the results of clinical trials, the timing of regulatoryapprovals, the integration of 3f Therapeutics and the surgical cryoablationbusiness of CryoCath Technologies, Inc., regulatory actions, competition,pricing pressures, supplier actions and management of growth. For adiscussion of these and other risks and uncertainties that could affect theCompany's activities and results, please refer to the Company's filings withthe Securities and Exchange Commission, including its Form 10-K for the year