Berlin Heart’s Excor pediatric VAD
The FDA granted a humanitarian device exemption to Berlin Heart’s Excor pediatric ventricular assist device, after a unanimous recommendation from the federal watchdog agency’s Circulatory System Devices Advisory Panel.
The pediatric VAD is a mechanical cardiac assist device for critically ill pediatric patients suffering from severe heart failure. The system supports patients from newborns to teenagers, helping to keep them alive while they’re awaiting heart transplantation.
"This is a step forward – it is the first FDA-approved pulsatile mechanical circulatory support device specifically designed for children," Dr. Susan Cummins, chief pediatric medical officer in the FDA’s Center for Devices & Radiological Health, said in prepared remarks. "Previous adult heart assist devices were too large to be used in critically ill children to keep them alive while they wait to get a new heart."
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Berlin Heart’s pediatric VAD consists of one or two external air-driven blood pumps connected to the heart chambers and arteries by multiple tubes.
Heart failure in children is less common than in adults, but there are far fewer pediatric donor hearts available. The average wait time for an infant donor heart is 119 days, according to the FDA.
In a 48-patient, non-randomized multi-center trial, the Excor device was compared to extracorporeal membrane oxygenation, the standard treatment for pediatric patients waiting for transplant. In spite of a 29% stroke rate, 90% of children survived to transplant or were successfully weaned off of the VAD device.
In July, the FDA’s Circulatory System Devices Advisory Panel voted 16-0 that Berlin’s Excor system be granted humanitarian device exemption.
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