News | November 25, 2008

First Commercial Implants of the ATS 3f Aortic Bioprosthesis Made in U.S.

November 26, 2008 - ATS Medical Inc. this week said the first three commercial implants of the ATS 3f Aortic Bioprosthesis were completed Nov. 17 and 18 by Allan Stewart, M.D., director, aortic surgery program at Columbia University Medical Center in New York.

The ATS 3f Aortic Bioprosthesis is the company’s first entry into the $400-plus million U.S. tissue valve market. The ATS 3f is a new 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,” said 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 tubular design of the ATS 3f Aortic Bioprosthesis maintains the continuity of the annulus and the sino-tubular junction. The company said no other valve mimics the native valve in this manner. By maintaining this continuity, the ATS 3f 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.

For more information: www.atsmedical.com

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