FDA approves device for treatment of congenital heart defects

The United States Food and Drug Administration has approved the Harmony Transcatheter Pulmonary Valve System, the first non-surgical heart valve to treat pediatric and adult patients with congenital heart defects, which affect approximately 40,000 babies each year.1 The device is intended to improve blood flow to the lungs without requiring open heart surgery.

The safety and efficacy of the device were evaluated in a prospective, non-randomized, multicenter clinical study. In the study, 70 patients had the device implanted. Each patient had follow-up exams scheduled during follow-up exams at the start of the study, at the implantation procedure, at discharge and after implantation at 1 month, 6 months and annually up to 5 years. The primary safety endpoint of the study was the absence of procedural or device-related death within 30 days of receiving impact, which was achieved in 100% of participants. The primary efficacy endpoint was the percentage of patients who had not undergone any additional device-related surgery or procedures and also had acceptable health blood flow function at 6 months, with 89.2% of participants meeting the efficacy endpoint.

Adverse events observed in the clinical study included implant movement (4.2%), pulmonary valve narrowing (4.2%), minor bleeding (7.0%), leakage around the valve (8.5%, including 1.4% major leak), and irregular or abnormal heartbeat (23.9%, including 14.1% ventricular tachycardia). The device is contraindicated for patients who have an infection in the heart or elsewhere, who cannot tolerate anticoagulant drugs, or who have sensitivity to titanium or nickel.


1. US Food and Drug Administration. The FDA approves the world’s first device to treat patients with congenital heart disease. Posted March 26, 2021. Accessed March 26, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-world-device-treat-patients-congenital-heart-disease

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