A Medical Device Daily

ATS Medical (Minneapolis) reported FDA approval of the ATS Open Pivot AP360 mechanical heart valve.

ATS said that the AP360 valve "combines hemodynamic performance with a supra-annular cuff design that facilitates implantation. The original ATS Open Pivot promoted hemodynamic performance, enhanced resistance to blood clot formation and improved patient quality of life through quieter valve operation... . the ATS AP360 combines proven performance with a cuff design that extends its appeal to a broader spectrum of surgeons."

Michael Dale, president/CEO of ATS said: "Heart valve sewing cuff material and design contribute to the ease with which suturing needles pass through the cuff and an uncomplicated positioning of the valve at the implant site. Surgeons develop a feel for, and gain confidence and comfort in, a cuff that is well suited to their individual surgical techniques."

"Our AP360 combines AP's superior hemodynamic performance with a new cuff design that will better suit the requirements of a significant additional segment of surgeons."

ATS makes products focused on cardiac surgery.