On Mar. 26, 2021, the U.S. Food and Drug Administration (FDA) approved the first in the world non-surgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT), the part of the heart that carries blood out of the right ventricle to the lungs.

The device, developed by Medtronic, is called the Harmony Transcatheter Pulmonary Valve (TPV) System, is intended to improve blood flow to the lungs in patients with severe pulmonary valve regurgitation without open-heart surgery, the current standard of care.