THE MELODY VALVE: Made from the jugular vein of a cow, the Melody Transcatheter Pulmonary Valve is a biological valve, so patients do not need to take blood thinning medications. Designed to treat patients with congenital heart defects involving the pulmonary artery, the Melody valve is inserted via catheter through a patient's groin, then guided to the heart. When it's properly positioned, a balloon in the device is inflated, implanting the device. This provides a non-surgical means to replace the valve -- without the pain and recovery time of open heart surgery. Surgeons and patients have reported immediate improvement in patient health and alleviation of symptoms. Patients are able to leave the hospital 24 hours after the operation. This technique avoids the risk of bleeding and infection that can accompany open heart surgery and reduces costs associated with ICU care.
It's not yet known how long the valve will last in a patient's body, but doctors hope it will last 10 to 15 years. When and if repeat surgery is needed, surgeons can re-enter the body through the same entryway. Not all Melody valve replacements enter through the groin. In a few cases, the catheter was inserted through a vein in the patient's neck, then guided to the heart. The Melody has received Europe's CE Mark of approval and is available for distribution in Europe and Canada. It is currently undergoing U.S. Food and Drug Administration (FDA) trials at three locations in the United States.
FOR MORE INFORMATION, PLEASE CONTACT:
Congenital Heart Institute at Miami Children's Hospital