FDA OKs Abbott's HeartMate 3 LVAD for Use in Children

Megan Brooks

December 18, 2020

The HeartMate 3 (Abbott) left ventricular assist device (LVAD) can now be used in pediatric patients with advanced refractory left ventricular heart failure who are awaiting heart transplantation or who are not candidates for heart transplantation, according to updated labeling approved by the US Food and Drug Administration (FDA).

The updated labeling was supported by clinical data from the Advanced Cardiac Therapies Improving Outcomes Network (ACTION Learning Collaborative). The consortium of more than 50 American pediatric hospitals pooled data to show advantageous outcomes of the HeartMate 3 LVAD in pediatric patients, Abbott explains in a news release.

In an early report on 35 patients (median age, 15.7 years) from nine ACTION centers, there was one death on device (97% survival) over a median follow-up of 78 days. Twenty patients underwent transplantation with no post-transplantation mortality. There were no episodes of stroke or pump thrombosis.

"This technology will benefit our pediatric patients and is a leap forward for improving heart failure outcomes in children," Angela Lorts, MD, and David Rosenthal, MD, cofounders of the ACTION Learning Collaborative, said jointly in the news release.

The continuous flow HeartMate 3 LVAD was first approved in the United States in 2017 for adults awaiting heart transplantion and was cleared in 2018 as long-term destination therapy for patients with advanced heart failure who are ineligible for heart transplantation.

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