FDA Clears ATS’ Mechanical Heart Valve
December 18, 2007 - ATS Medical Inc. today announced it has received FDA clearance for the ATS Open Pivot AP360 Mechanical Heart Valve designed to maximize hemodynamic performance with a new supra-annular cuff design that facilitates implantation.
In response to the highly individualized and specific valve selection criteria of cardiac surgeons, particularly with respect to implantability, the ATS AP360 cuff design reportedly extends its appeal to a broader spectrum of surgeons. According to the company, the AP360 will allow it to reapproach those interested in the ATS Open Pivot Heart Valve story, but who want a cuff more compatible with their preferences.
"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 hemodynamic performance with a new cuff design that will better suit the requirements of a significant additional segment of surgeons,” said ATS Medical President and CEO Michael Dale.
For more information: www.atsmedical.com