Medtronic has received the FDA approval for its '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.
The 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.
FDA said that like other valves, Melody does not cure the heart condition and over time, it 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.
Jeffrey Shuren, director of Center for Devices and Radiological Health at FDA, said: The FDA’s approval of Melody allows patients to undergo a much less invasive procedure to treat their heart condition. 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.”
Clinical studies on the device showed similar, limited durability compared to existing alternative treatments. Over 21% of US participants experienced a stent fracture, a rate consistent with stent fractures reported for the bare metal stents presently used to treat congenital heart defects of the pulmonary valve.
FDA approved the Melody under the Humanitarian Device Exemption (HDE) program, which supports the development of medical devices intended to benefit patients in the treatment or diagnosis of diseases, or conditions affecting fewer than 4,000 people in the US per year.