The ATS 3f Aortic Bioprosthesis is the Company's first entry into the $400-plus million U.S. tissue valve market. 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 ATS 3f Aortic Bioprosthesis is the only tissue valve that preserves the sinuses and restores native valve stress distribution and physiologic flow to the entire aortic root," commented Dr. Stewart. "All three patients achieved postoperative aortic function that is nearly indistinguishable from a healthy native aortic valve. All three patients have been discharged with an excellent prognosis and remarkably low pressure gradients of 4, 2, and 0 mm Hg."
"The commercial launch of our first tissue valve in the U.S. is an important milestone for ATS Medical," added Mr. Dale, President and Chief Executive Officer of ATS Medical. "The tissue valve market presents the largest market opportunity of our current products and will importantly provide ATS Medical the leverage it needs to sustain high growth and enhanced profitability in the future. We are grateful to Dr. Stewart for his commitment to science and excellent patient care."
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 U.S. surgeons. The Company is currently conducting a limited launch of the ATS 3f Aortic Bioprosthesis at a few select institutions in the fourth quarter of 2008 and plans a broader launch of the valve during the first quarter of 2009.
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.
