USFDA approves non-surgical device to treat congenital heart disease

The US Food and Drug Administration (FDA) has approved the first in the world non-surgical heart valve to treat paediatric and adult patients with a native or surgicallyrepaired right ventricular outflow tract (RVOT), the part of the heart that carries blood out of the right ventricle to the lungs. The device is designed for patients who have severe pulmonary valve regurgitation (blood leaking backwards into the right lower chamber of the heart), a condition that often results from congenital heart disease. The device, called the Harmony Transcatheter Pulmonary Valve (TPV) System by Medtronic, is intended to improve blood flow to the lungs in patients with severe pulmonary valve regurgitation without open-heart surgery, which is the current standard of care. The use of the Harmony valve may delay the time before a patient needs additional open-heart surgery. It can also potentially reduce the total number of open-heart surgeries required over an individual’s lifetime.