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news.ATS Medical, a manufacturer and marketer of cardiac surgery products and services, has received FDA approval for the ATS 3f Aortic Bioprosthesis. This is the company's first entry into the US tissue valve market.
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Based on the precept that ‘form follows function’, the ATS 3f Aortic Bioprosthesis is a stentless pericardial aortic tissue valve that is said to be 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. 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, the company said.
The ATS 3f Aortic Bioprosthesis is manufactured in Lake Forest, California, and is the first product within the 3f platform to earn the FDA premarket 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 over 100 implanted patients. ATS Medical expects CE Mark approval of ATS 3f Enable in the first half of 2009.
Michael Dale, chairman, president and CEO of ATS Medical, said: “This is a major milestone that will allow ATS Medical to leverage the expertise of our US sales organization and capitalize on the significant brand equity we have established in the marketplace with the ATS Open Pivot heart valve, ATS Simulus annuloplasty products and the ATS CryoMaze surgical ablation product line.”