The Food and Drug Administration has approved Medtronic Inc’s heart valve that can be implanted without open-heart surgery. Known as the Melody transcatheter pulmonary valve, the device is designed to be implanted through a small catheter inserted into the patient’s body. It replaces the pulmonary valve in patients born with a heart defect. It is the first heart valve approved for sale in the US that can be implanted without open-heart surgery.

The advisory panel for the FDA has backed a new type of heart valve that can be implanted without the open heart surgery required for traditional valves. Medtronic Inc’s Melody heart valve has been recommended for approval for the group of people born with cardiac defects that impede blood flow from the right ventricle to the pulmonary artery. The device can be implanted by threading a tube through a leg vein to the heart.

Panel recommends Melody Transcatheter Pulmonary Valve
The FDA’s Circulatory System Devices Panel has unanimously recommended the approval of Humanitarian Device Exemption of Medtronic’s Melody Transcatheter Pulmonary Valve. The device is designed for patients with congenital heart defects, status post open heart surgery, who developed right ventricular outflow tract (RVOT) obstruction. The Melody Transcatheter Pulmonary Valve is the first transcatheter heart valve to be approved for commercial use anywhere in the world and the first to be reviewed by an FDA panel.