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FDA approves transcatheter pulmonary valve for patients with congenital heart disease
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Medtronic announced that the FDA has granted pre-market approval to its Melody transcatheter pulmonary valve.
The valve was originally approved in 2010 under a Humanitarian Device Exemption, which is granted to devices intended for fewer than 4,000 patients per year for which safety is reasonably assured and evidence indicates a probable benefit, but there is insufficient data on effectiveness. The PMA approval means that there is now enough evidence available to support both the safety and effectiveness of the device, according to a Medtronic press release.
The valve is a therapy intended to prolong the time between open-heart surgeries for patients with a dysfunctional right ventricular outflow tract conduit due to congenital heart disease, according to the release. Medtronic stated that of the more than 7,300 patients who have received the therapy, more than half are children with congenital heart disease.
The PMA was granted after the FDA reviewed three studies following 310 patients implanted with the valve: The Melody U.S. IDE Study, the Melody U.S. Post-Approval Study and the Melody European and Canadian Post-Market Surveillance Study. In those studies, approximately 98% of patients implanted with the valve were free from open-heart surgery at 1 year, and in the IDE study, 91% of patients were free from open-heart surgery at 5 years, according to the release.