FDA Approves Edwards' Rapid-Deployment Minimally Invasive Surgical Valve

The system combines the company's proven tissue surgical valve platform with technology developed for transcatheter valves.

Deployed Edwards Intuity Elite Valve 6-HR
Intuity Elite rapid-deployment aortic valve • Source: Edwards Lifesciences Corp.

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

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