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ATS Medical wins Japanese approval for new mechanical heart valve

ATS Medical has received approval from the Japanese Ministry of Health, Labor and Welfare for commercial distribution of the ATS Open Pivot AP360 mechanical heart valve.

According to ATS Medical, the 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, claims ATS Medical.

Michael Dale, president and CEO of ATS Medical, said: “The newly approved AP360 will provide even more opportunity to further penetrate the Japanese marketplace. Our long time distribution partner, Century Medical, 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.”