ATS Medical, Inc. has announced the Japanese Ministry of Health, Labor and Welfare approval for the commercial distribution of the ATS Open Pivot AP360 Mechanical Heart Valve. The company’s ATS AP360 heart valve maximizes hemodynamic performance with a new supra-annular cuff design that facilitates implantation. The original ATS Medical Open Pivot Heart Valve is highly regarded for fundamental design features that promote best-in-class hemodynamic performance, enhanced resistance to blood clot formation and improved patient quality of life through quieter valve operation. In a response to the highly individualized and specific valve selection criteria of cardiac surgeons, particularly with respect to implantability, the ATS AP360 combines proven performance with a cuff design that extends its appeal to a broader spectrum of surgeons. "Our long time distribution partner, Century Medical, Inc., worked diligently to facilitate this important approval in conjunction with the ATS Quality and Regulatory Organization. The cuff design of the ATS AP360 valve provides significant hemodynamic benefit for patients with a small aortic root and will be ideal for the unique needs of the Japanese market," said Michael Dale, President and CEO of ATS Medical. "The newly approved AP360 will provide even more opportunity to further penetrate the Japanese marketplace."