FDA Approves Jarvik Heart Trial for Pediatric Cardiac Assist Device

The FDA has granted conditional approval to perform an investigational device exemption study of Jarvik Heart’s new miniature Left Ventricular Assist Device (LVAD) System. The study will compare the implanted, portable electrically powered Jarvik 15mm LVAD System with the Berlin Heart Excor Pediatric System.

The 15mm-diameter device is designed for patients under one year up to about age ten and may provide long-term support in children for whom no donor heart is available.

The study is managed by the New England Research Institutes and will enroll 88 patients from about 20 institutions in the U.S. and Canada. The study will compare the ability of the two systems to provide circulatory support as a bridge to transplant, assessed over a six-month period. — Cynthia Jessup