Medtronic's Harmony TPV System Receives Historic FDA Approval for Congenital Heart Disease

The FDA announced approval for the Harmony Transcatheter Pulmonary Valve device for treatment of patients with native or surgically-repaired right ventricular outflow tract was awarded to Medtronic Inc.

The US FDA has announced the approval of the Harmony Transcatheter Pulmonary Valve (TPV) System for the treatment of congenital heart disease (CHD), providing patients with a less invasive option for treatment of pulmonary valve regurgitation.

The historic approval makes the Harmony TPV System the first non-surgical heart valve approved in any country to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT).

The Harmony TPV provides a new treatment option for adult and pediatric patients with certain types of congenital heart disease. It offers a less-invasive treatment alternative to open-heart surgery to patients with a leaky native or surgically-repaired RVOT and 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, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, in a statement from the FDA.

Developed by Medtronic Inc., the Harmony TPV System is designed to improve blood flow to the lungs in patients with severe pulmonary valve regurgitation without the need for open-heart surgery, which could reduce number of surgeries required over a patient’s lifespan. The landmark approval from the FDA comes based on the results of a prospective, non-randomized, multicenter study that saw the Harmony TPV System implanted in a total of 70 patients.

Patients in this study were assessed at the implant procedure, discharge, and post-implant at 1 month, 6 months, and annual through 5 years. The primary safety endpoint of the study was the absence of procedure- or device-related death within 30 days of implant, which was achieved in 100% of patients. For efficacy, the primary endpoint was the percentage of patients with no additional surgical or interventional procedures related to the device and acceptable heart blood flow function at 6 months. In total, 89.2% of patients achieved the primary efficacy endpoint.

Adverse events observed during this clinical trial included irregular or abnormal heart rhythms (23.9%), leakage around the valve (8.5%), minor bleeding (7.0%), narrowing of the pulmonary valve (4.2%), and movement of the implant (4.2%).

Based on the approval, the Harmony TPV System is contraindicated for patients with an infection in the heart or else, patients who are unable to tolerate blood thinning medications, and patients who have sensitivity titanium or nickel.

The release from the FDA noted the Harmony TPV System was approved using the Premarket Approval (PMA) pathway. The release noted this is the most stringent type of device marketing application required by the FDA and is based on a determination by the FDA that the Harmony TPV PMA application contained sufficient scientific evidence.

"The availability of the Harmony TPV will allow a broader range of congenital heart disease patients access to transcatheter technology," said Nina Goodheart, president of the Structural Heart & Aortic business, which is part of the Cardiovascular Portfolio at Medtronic, in a statement from Medtronic Inc. "Harmony TPV's novel attributes make it the only non-surgical solution designed to adapt to a wide variety of anatomies for this specific patient population living with congenital heart disease."