FDA Makes It Official On Sapien™

The U.S. FDA has issued a formal press announcement about its approval of Edwards Lifesciences’ Sapien transcatheter heart valve (THV) for extended indications. The device was originally only approved for use in patients considered inoperable by conventional surgery, but is now available for patients considered to be “high risk”.

What’s interesting in the data submitted from the study is that the risk of mortality in Sapien patients was similar to conventional aortic valve replacement surgery, but the complications were different with the conventional group more at risk of intraoperative bleeding while the transcatheter group was more at risk from vascular complications and stroke.

FDA comments: “Any procedure to replace the aortic valve carries the risk for serious complications, but for some patients with coexisting conditions or diseases that risk may be especially high,” said Christy Foreman, director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health. “The THV serves as an alternative for some very high-risk patients.”

Source: FDA