FDA approves device for treatment of congenital heart defects


The US Food and Drug Administration (FDA) has given the stamp of approval for Harmony Transcatheter Pulmonary Valve System, a first in the world device to treat congenital heart defects.

The US Food and Drug Administration has approved the Harmony Transcatheter Pulmonary Valve System, the first non-surgical heart valve to treat both pediatric and adult patients with congenital heart defects, which affects roughly 40,000 babies every year.1 The device is meant to improve the blood flow to the lungs without the need for open-heart surgery.

The device’s safety and efficacy were assessed in a prospective, nonrandomized, multicenter clinical study. In the study, 70 patients had the device implanted. Each patient had follow-up examinations scheduled at follow-up examinations at the start of the study, at implant procedure, discharge, and post implant at 1 month, 6 months, and annually through 5 years. The primary safety endpoint for the study was no procedure- or device related death within 30 days of receiving the impact, which was achieved in 100% of the participants. Primary efficacy endpoint was the percentage of patients who had no additional surgical or interventional procedures linked to the device and also had acceptable heath blood flow function at 6 months, with 89.2% of participants reaching the effectiveness endpoint.

The adverse events seen in the clinical study included movement of the implant (4.2%) narrowing of the pulmonary valve (4.2%), minor bleeding (7.0%), leakage around the valve (8.5%, which included 1.4% major leakage), and irregular or abnormal heart rhythm (23.9%, including 14.1% ventricular tachycardia). The device is contraindicated for patients who have an infection in their heart or elsewhere, can’t tolerate blood thinning drugs, or who have a sensitivity to titanium or nickel.


1. US Food and Drug Administration. FDA approves first in the world device to treat patients with congenital heart disease. Published 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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