The first in the world non-surgical heart valve has been approved by the U.S. FDA for the treatment ofchildren and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT). 

The device is intended for use in patients with severe pulmonary valve regurgitation. The Harmony Transcatheter Pulmonary Valve (TPV) System aims to improve blood flow to the lungs in patients with severe pulmonary valve regurgitation without having to do open-heart surgery. The use of the new device is expected to delay the time before a patient needs additional open-heart surgery. The use of the device may also decrease the total number of open-heart surgeries required over a person’s lifetime… (FDA, March 26, 2021)