Edwards Lifesciences Corp.'s Intuity Elite rapid-deployment aortic valve replacement is now commercially available in the US. FDA approved the device based on clinical data showing it may reduce cross-clamp time and cardiopulmonary bypass time compared totraditional aortic valve replacement surgery.
The agency approved the Intuity Elite bioprosthesis on August 12 for a broad indication: The replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Edwards announced US commercial...