The U.S. Food and Drug Administration (FDA) approved of the first-ever valve for treating pulmonary valve regurgitation in patients with certain kinds of congenital heart disease. The device, called Harmony Transcatheter Pulmonary Valve (TPV) has been granted breakthrough device designation, and is a less invasive option for open-heart repair. The Harmony TPV is inserted into a major vein before collapsing through a catheter into a major vein right ventricular outflow tract (RVOT) so the deoxygenated blood flows from the heart to the lungs, before the valve is released and it self-expands and anchors to the RVOT so it functions as the original valve would.
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