About 5 years after the Melody Transcatheter Pulmonary Valve was approved by
the FDA under a Humanitarian Device Exemption (HDE), the Medtronic implant has
now been given full PMA approval by the agency, claims the company.
The Melody TPV is a minimally invasive approach to prolonging the time
between open-heart surgeries for patients with a dysfunctional right
ventricular outflow tract conduit caused by congenital heart disease.
An HDE is intended for devices that will be used in fewer than 4,000 U.S.
patients per year; if a device has been demonstrated to have reasonable safety
and probable benefit, it doesn't have to be shown to be clinically effective to
be approved via this pathway.
In order to make the transition from HDE to PMA approval, Medtronic
conducted three clinical trials of the device in a total of 310 patients. In
that testing, about 98% of patients did not require open-heart surgery after
one year with the Melody TPV implanted. Even after 5 years, 91% of patients
with the implant in one of the trials didn't need open-heart surgery.
"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. This approval underscores the valve's importance in treating this
small patient population, who over their lifetime will face several open-heart
surgeries," said Dr. William Hellenbrand, chief of pediatric cardiology at
the Yale School of Medicine and a principal investigator for the device.