ATS Medical, Inc., manufacturer and marketer of state-of-the-art cardiac surgery products and services,announced it has received U.S. Food and Drug Administration (FDA) approval for the ATS 3f(R) Aortic Bioprosthesis. 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 replacement valve.
ATS Medical, Inc., manufacturer and marketer of state-of-the-art cardiac surgery products and services,announced it has received U.S. Food and Drug Administration (FDA) approval for the ATS 3f(R) Aortic Bioprosthesis. 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 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.
Michael Dale, Chairman, President and CEO said, This FDA approval is our first Class III PMA Approval since the reorganization of ATS Medical in October 2002 to become a leader in the treatment of structural heart disease with a focus on serving the unique requirements of cardiac surgeons. This is a major milestone that will allow ATS Medical to leverage the expertise of our U.S. sales organization and capitalize on the significant brand equity we have established in the marketplace with the ATS Open Pivot(R) heart valve, ATS Simulus(TM) annuloplasty products and the ATS CryoMaze(TM) surgical ablation product line.
The ATS 3f Aortic Bioprosthesis is manufactured in Lake Forest, California, and is the first product within the 3f platform to earn FDA PMA approval. The second generation ATS 3f Enable(R) 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 said, This FDA approval is our first Class III PMA Approval since the reorganization of ATS Medical in October 2002 to become a leader in the treatment of structural heart disease with a focus on serving the unique requirements of cardiac surgeons. This is a major milestone that will allow ATS Medical to leverage the expertise of our U.S. sales organization and capitalize on the significant brand equity we have established in the marketplace with the ATS Open Pivot(R) heart valve, ATS Simulus(TM) annuloplasty products and the ATS CryoMaze(TM) surgical ablation product line.
The ATS 3f Aortic Bioprosthesis is manufactured in Lake Forest, California, and is the first product within the 3f platform to earn FDA PMA approval. The second generation ATS 3f Enable(R) 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.
