The U.S. Food and Drug Administration, Monday approved Melody Transcatheter Pulmonary Valve and Ensemble Delivery System of Medtronic Inc. (MDT) under its Humanitarian Device Exemption program.
Melody is 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, the surgically implanted valves used to treat congenital heart defects of the pulmonary valve, have a limited lifespan and often require replacement. Melody is intended to provide another option to conduit replacement.
Melody does not cure the heart condition and over time it may wear and require replacement. It, however, 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.
This allows a patient's conduit to function longer than usual, which can delay the need for more invasive open-heart surgery.
Pediatric patients with right-sided valvular heart disease are specially benefiting from the approval as they may face several surgeries over their lifetimes.
The approval was supported by clinical studies of 99 participants in the United States and 68 participants in Europe. The studies revealed that the device improved function of the heart and the majority of participants have noted improvements in their clinical symptoms.
As a condition of the FDA's approval, Medtronic will conduct two post-approval generalizability studies to assess long-term risks and benefits as well as to evaluate the physician specialization needed to perform the implantation procedure.
One study will continue to follow 150 participants from the initial clinical trial for five years and the second study will enroll more than 100 new participants to be evaluated over five years, in order to evaluate and assess the training program.
The approval of Melody was under the Humanitarian Device Exemption program, which approves a device for limited use and prohibits from selling that device for an amount that exceeds the costs of research and development, fabrication and distribution of the device.
An agency-specified number of Melody devices that are sold each year and intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients, however, are exempted from the prohibitions, due to a provision in the Pediatric Medical Device Safety and Improvement Act of 2007.
MDT is currently trading at $44.28, up 0.98 or 2.26%, on a volume of 2.35 million shares on the NYSE.
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