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.

Japan’s Ministry of Health, Labor and Welfare has granted regulatory approval to St. Jude Medical for its SJM Tailor flexible ring and band. These products are used to repair damaged mitral and tricuspid heart valves in the heart. These are the company’s first heart valve products being released in Japan and already have approval in the U.S. and Europe.