For years, innovations in the treatment of pulmonary valve regurgitation have relied on invasive surgical treatments—until now. A device from Medtronic that takes a minimally invasive approach to treating patients with congenital heart disease has become the first of its kind to snag approval from the FDA.
Medtronic’s Harmony Transcatheter Pulmonary Valve can be used in both pediatric and adult patients with congenital heart disease, which affects more than two million patients of all ages in the U.S., the medtech giant estimates. About one in five will have structural malformations in the passage leading out of the heart toward the lungs, hampering the blood flow, which the valve corrects by opening and closing as necessary to prevent the blood from flowing backward.
Implantation of the device has the potential not only to increase the amount of time before a patient’s next open-heart surgery, the current standard of care, but also to decrease the number of open operations they may have over their lifetime, the company said.
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The Harmony valve "may help patients improve their quality of life and return to their normal activities more quickly, thus fulfilling an unmet clinical need of many patients with congenital heart disease,” said Bram Zuckerman, M.D., director of the FDA’s Office of Cardiovascular Devices.
The agency based its approval, which followed a breakthrough device designation, on a multi-center clinical study of 70 patients implanted with the device, each of whom will continue to be evaluated annually for a decade following the procedure.
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The device’s effectiveness was measured by the number of surgical procedures or other interventions required to correct the device or heart blood flow function within six months of implantation; nearly 90% of the study’s patients required no further interventions during that period.
The Harmony valve is built off Medtronic's previous Melody transcatheter implant, which replaces the pulmonary valve entirely and received an FDA humanitarian device exemption in 2015. Last year, the company presented long-term data showing the Melody valve's sustained function and stability, with 97% of patients showing mild, trace or no regurgitation after 10 years—including among children as they grow.
Many patients may receive a tube implant early in life to fix disruptions in the outflow tract. But once they outgrow that conduit or it's no longer functional, the Melody valve is designed to help delay additional surgeries. In the decade-long study, 61% of implanted patients did not need an additional procedure or catheter-based reintervention.