The U.S. Food and Drug Administration (FDA) on Monday approved the Medtronic Melody transcatheter pulmonary valve and ensemble delivery system, the first heart valve to be implanted through a catheter, or tube, in a leg vein and guided up to the heart.
This new approach to the treatment of adults and children with previously implanted, poorly functioning pulmonary valve conduits can delay the need for open-heart surgery.
Conduits are surgically implanted valves used to treat congenital heart defects of the pulmonary valve. Patients with congenital heart defects have narrowed, leaky, or missing pulmonary valves that impede the proper flow of
blood from the heart's right ventricle to the pulmonary artery, which then sends the blood on to the lungs for oxygenation. Conduits can have a limited lifespan and often require replacement. The Melody is intended to provide another option to conduit replacement.
"The FDA's approval of Melody allows patients to undergo a much less invasive procedure to treat their heart condition," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health. "Congenital heart
defects represent the number one birth defect worldwide and this approval represents a new, first-of-a-kind treatment option for some of those patients."
Like other valves, the Melody does not cure the heart condition and over time, the Melody may wear and require replacement. However, it is implanted without open heart surgery, can prop open the poorly functioning conduit, and can keep blood flowing in the proper direction because of the tissue valve in the Melody. These characteristics will allow a patient's conduit to function longer than usual, which can delay the need for more invasive open-heart surgery.
Clinical studies of 99 participants in the United States and 68 participants in Europe showed that the device improved function of the heart, and the majority of participants have noted improvements in their clinical symptoms.