A Medical Device Daily
ATS Medical (Minneapolis), a maker of cardiac surgery products, said it has received FDA approval for the ATS 3f Aortic Bioprosthesis.
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 valve design that reproduces the functional characteristics of the native aortic valve. This 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.
"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," said Michael Dale, president/CEO and chairman. "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 heart valve, ATS Simulus annuloplasty products and the ATS CryoMaze surgical ablation product line. Finally, this achievement is a testament to the competence, perseverance and vision of our employees, the founders of 3f and our clinical investigators who for more than six years committed themselves to bring an important solution forward for the advancement of cardiac surgery and patient well-being."