FDA Approves First-Ever Device to Treat Congenital Heart Disease Complications

The US Food and Drug Administration (FDA) has granted breakthrough device designation to Harmony Transcatheter Pulmonary Valve (TPV) System, a first in the world device for the treatment of pediatric and adult patients with congenital heart disease.

Developed by Medtronic, Inc., the device is intended for patients with a native or surgically-repaired right ventricular outflow tract (RVOT) who experience pulmonary valve regurgitation. The Harmony TPV is designed to improve blood flow to the lungs in patients without the need for surgery.

“The Harmony TPV provides a new treatment option for adult and pediatric patients with certain types of congenital heart disease,” said Bram Zuckerman, MD, director of the Office of Cardiovascular Devices, FDA's Center for Devices and Radiological Health, in a statement.

“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," he continued.

Severe pulmonary valve regurgitation can occur following heart procedures in those with congenital heart defects (CHDs), a condition which affects 40,000 infants born each year. Current United States estimates place the incidence of CHDs in infants, children, adolescents, and adults at 2 million.

A Clinical Trial

The approval was based on a prospective, non-randomized, multi-center clinical study.

Physicians implanted the device in 70 patients, who then received follow-up examinations at study initiation, implant procedure, discharge, and 1 month, 6 months, and annually through 5 years post-implant.

The primary safety endpoint was no procedure or device-related death within 30 days after device implant. All patients achieved this endpoint.

Further, 89.2% of patients achieved the primary effectiveness endpoint, which was defined as no additional surgical or interventional procedures related to the device as well as acceptable heart flow at 6 months.

Adverse events associated with the implant were 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%).

Further post-approval follow-up will occur through 10 years.

The Harmony TPV is contraindicated for patients with an infection in the heart or elsewhere, in addition to those who are unable to tolerate blood thinning medicine or are sensitive to Nitinol.