Medtronic (NYSE:MDT) said today that it won pre-market approval from the FDA for its Melody transcatheter pulmonary valve, which is designed to delay the time between open heart surgeries in patients with a faulty connection from the heart to the lungs.
Fridley, Minn.-based Medtronic said the Melody TPV is designed for patients with a dysfunctional right ventricular outflow tract conduit caused by congenital heart disease. The PMA nod came after data from a trio of studies showed the valve’s effectiveness in delaying open heart procedures, according to a press release.
Medtronic won a humanitarian device exemption from the federal safety watchdog back in 2010. Congenital heart disease is the most common birth defect in the U.S., according to the release, affecting an estimated 40,000 patients annually; about 20% of those have disrupted blood flow from the right ventricular outflow tract to the pulmonary arteries. Some of those babies, implanted with a conduit designed to improve flow, are candidates for the Melody valve if their conduit fails but can still accommodate the implant, Medtronic said.
"The transition from HDE to PMA is an important regulatory milestone, which truly emphasizes the significant clinical benefit that the Melody TPV can bring to people with CHD by providing a therapy option that may reduce the number of open heart surgeries they need throughout their lifetime," heart valve therapies general manager Rhonda Robb said in prepared remarks. "Today’s approval reinforces Medtronic’s ongoing commitment to a congenital heart disease program by providing innovative and successful therapies to this underserved patient group.”
“The Melody valve has been a reliable option for patients suffering from CHD, and these data reinforce its strong performance since it was first introduced," added Dr. William Hellenbrand of the Yale School of Medicine. "This approval underscores the valve’s importance in treating this small patient population, who over their lifetime will face several open heart surgeries."
Medtronic said the 3 studies backing its successful PMA bid showed that 98% of patients implanted with the Melody valve were free from the need for open heart procedures for 1 year after implantation; in 1 of the trials, that rate was 91% after 5 years.
