The FDA approved the world's first non-surgical heart valve to treat severe pulmonary valve regurgitation, which often affects individuals with congenital heart disease. Medtronic plc’s Harmony transcatheter pulmonary valve system (TPV) improves blood flow to the lungs without open-heart surgery. The device could extend the time before an individual born with heart disease needs open-heart surgery and the total number of such surgeries they have to endure over their lifetime.
Boston Scientific Corp.'s Therasphere Y-90 glass microspheres received a PMA for treatment of patients with unresectable hepatocellular carcinoma (HCC). The radioembolization technique has been used in more than 70,000 patients under a humanitarian device exemption over the last 20 years. The U.K.'s NICE also recently recommended Therasphere for treatment of patients with HCC.
A U.S. FDA advisory committee voted 14 nays to three ayes that the benefits of the Lutonix 014 drug-coated balloon (DCB) do not outweigh the risks in a panel proceeding peppered by problems with missing data and a lack of operator blinding. The panel widely saw the use of paclitaxel-eluting technologies in other areas of the vasculature as a reassurance that this device might perform as promised, but the outcome nonetheless leaves the sponsor with a new round of negotiations with the FDA as to how to move forward.