Edwards SAPIEN 3 Aortic Heart Valve

Edwards announced that the FDA has issued the company approval to introduce its latest transcatheter aortic heart valve, the SAPIEN 3, including the Commander Delivery System,  to the U.S. market. The device was designed to lower the chances of leakage around the valve, which should reduce various side-effects, including the potential for stroke.

The SAPIEN 3 now has an outer layer of polyethylene terephthalate over the frame of the device that more consistently plugs blood flow from having a chance to pass through outside of the valve.

FDA’s decision was based on a clinical trial that included almost 600 high-risk patients.