The FDA has yet another private listing of device-related deaths, this one for transcatheter aortic valve replacement (TAVR) devices that include Medtronic’s (NYSE:MDT) CoreValve and Edwards Lifesciences’ (NYSE:EW) Sapien 3 lines, according to a new report by Kaiser Health News.
Both devices were initially indicated for patients who were too frail or ill for open-heart surgery, but the FDA subsequently approved them for intermediate- and low-risk patients. TAVR devices are placed percutaneously, with a physician using a catheter to thread the device to the heart.
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