MINNEAPOLIS, Dec. 8 /PRNewswire-FirstCall/ -- ATS Medical, Inc. (Nasdaq: ATSI - News), manufacturer and marketer of state-of-the-art cardiac surgery products and services, today announced it has received FDA clearance for the marketing of the ATS 3f® Aortic Bioprosthesis that includes a new sewing tab material supplier and an improved valve holder accessory device.
While the ATS 3f Aortic Bioprosthesis PMA was approved on October 30, 2008, as previously indicated, a full commercial launch would commence in the first quarter of 2009 once these milestones were achieved. ATS Medical has achieved these milestones and is on track with the previous guidance. The ATS 3f Aortic Bioprosthesis is the Company’s first entry into the $400-plus million U.S. tissue valve market.
“The FDA clearance was necessary for ATS Medical to commence a full commercial launch of our first tissue valve in the US. We are excited to achieve these important milestones for the Company,” said Michael Dale, President and Chief Executive Officer of ATS Medical. “The tissue valve market presents the largest market opportunity for our Company and will importantly provide ATS Medical the leverage it needs to sustain high growth and enhanced profitability in the future.”
Based on the precept that ‘Form Follows Function’, the ATS 3f Aortic Bioprosthesis is a revolutionary next generation stentless pericardial aortic tissue valve that is unlike any other valve. The tubular design of the ATS 3f Aortic Bioprosthesis maintains the continuity of the annulus and the sino tubular junction. No other valve mimics the native valve in this manner. By maintaining this continuity, the ATS 3f Aortic Bioprosthesis preserves the aortic sinuses and restores native valve stress distribution and physiologic blood flow. This elegant design provides surgeons and patients with a potentially more durable solution to aortic valve replacement. With more than six years of clinical experience confirming excellent safety and efficacy, the demonstrated clinical benefit and recent FDA approval of the ATS 3f Aortic Bioprosthesis are creating excitement and product demand among US surgeons.
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 160,000 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.
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 outcome of pending litigation matters, 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 and its most recent quarterly report on Form 10-Q.
Source: ATS Medical, Inc.
