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

The United States Food and Drug Administration (FDA) has granted revolutionary device designation to the Harmony Transcatheter Pulmonary Valve System (TPV), the world’s first device for the treatment of pediatric and adult patients with congenital heart disease.

Developed by Medtronic, Inc., the device is intended for patients with native or surgically repaired right ventricular outflow tube (RVOT) and pulmonary valve regurgitation. The Harmony TPV is designed to improve blood flow to the lungs in patients without 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, Center for Devices and Radiologic Health, FDA , in a press release.

“It offers a less invasive treatment alternative to open heart surgery for patients with native or surgically repaired RVOT and can help patients improve their quality of life and return to normal activities more quickly, thus meeting a clinical need.” not satisfied with many patients with congenital heart disease, ”he continued.

Severe pulmonary valve regurgitation can occur as a result of cardiac procedures in people with congenital heart defects (CHD), a condition that affects 40,000 infants born each year. Current US estimates place the incidence of coronary heart disease in infants, children, adolescents and adults at 2 million.

A clinical trial

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

Doctors implanted the device in 70 patients, who then underwent follow-up examinations at the start of the study, the implantation procedure, the discharge and 1 month, 6 months and annually for up to 5 years after implantation. .

The primary safety outcome was no procedure or device-related death within 30 days of device implantation. All patients met this criterion.

In addition, 89.2% of patients achieved the primary efficacy endpoint, which was defined as no additional surgical or interventional procedures related to the device as well as acceptable cardiac output at 6 months.

Adverse events associated with the implant were irregular or abnormal heart rhythms (23.9%), valve leakage (8.5%), minor bleeding (7.0%), valve narrowing pulmonary (4.2%) and implant movements (4.2%). %).

Additional post-approval monitoring will take place for 10 years.

Harmony TPV is contraindicated for patients with an infection in the heart or elsewhere, in addition to those who cannot tolerate anticoagulants or who are sensitive to nitinol.