About 5 years after the Melody Transcatheter Pulmonary Valve was approved by the FDA under a Humanitarian Device Exemption (HDE), the Medtronic ($MDT) implant has now been given full PMA approval by the agency. 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 (RVOT) 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," Dr. William Hellenbrand, chief of pediatric cardiology at the Yale School of Medicine and a principal investigator for the device, said in a statement. "This approval underscores the valve's importance in treating this small patient population, who over their lifetime will face several open-heart surgeries."
The Melody TPV procedure takes about one to two hours. The catheter is inserted into the patient's femoral vein and guided to the heart. Once in position in the heart, the balloons are inflated and the valve expands into place to allow blood flow between the right ventricle and lungs. Once the catheter is removed, fluoroscopy is used to confirm that the valve is functioning properly.
More than 7,300 patients globally have received the Melody TPV, more than half of whom were children with congenital heart disorders (CHD). The most common U.S. birth defect, CHD affects about 40,000 U.S. infants annually. About 20% of them have deformities that disrupt blood flow from their RVOT to the pulmonary arteries.
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