News | November 03, 2008

ATS Medical Gets FDA Clearance for ATS 3f Aortic Bioprosthesis

November 4, 2008 - ATS Medical Inc. recently received FDA approval for the ATS 3f Aortic Bioprosthesis, a stentless pericardial aortic tissue valve that is unlike any other replacement valve.

Mimicking the native aortic valve’s function as a tubular structure whose sides collapse in response to pressure, the ATS 3f Aortic Bioprosthesis is based on a proprietary valve design that reproduces the functional characteristics of the native aortic valve, the company said. This novel design results in a normal distribution of stress on the valve leaflets and laminar, non-turbulent blood flow across the prosthetic valve that is characteristic of a normal, native aortic valve.

With more than six years of clinical experience confirming safety and efficacy, the ATS 3f Aortic Bioprosthesis’ combination of normal blood flow dynamics and improved stress distribution provides surgeons and patients with a potentially more durable and physiologic solution to aortic valve replacement, the company said.

“The tubular design of the ATS 3f valve sets it apart from all other valves,” said Richard Shemin, M.D., professor of cardiothoracic surgery, chief, division of cardiovascular center executive vice chairman, department of surgery, David Geffen School of Medicine at UCLA, one of the lead investigators in the pivotal clinical trial for the ATS 3f Aortic Bioprosthesis. “The preservation of the aortic root is an innovative design element that returns native flow, increases coronary perfusion and appropriately distributes cardiac stress. In addition, the ease of implantation and potential for longer term durability makes this an excellent choice for my patients.”

The ATS 3f Aortic Bioprosthesis is manufactured in Lake Forest, CA, and is the first product within the 3f platform to earn FDA PMA approval. The second generation ATS 3f Enable Aortic Bioprosthesis, which is comprised of the ATS 3f tissue valve mounted in a self expanding nitinol frame, is currently under clinical investigation in select centers in Europe with more than 100 implanted patients. ATS Medical expects CE Mark approval of ATS 3f Enable in the first half of 2009.

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