FDA Expands Labeling of Abbott’s HeartMate 3™ LVAD for Pediatric Use with Collaboration from ACTION

ACTION centers collaborate with Abbott to update FDA labeling of the HeartMate 3 LVAD for use in pediatrics

CINCINNATI — The FDA has updated Abbott’s HeartMate 3™ LVAD labeling to treat children with heart failure. Collaborating with Abbott, ACTION’s clinicians, researchers, parents and patients from over 50 medical institutions provided high-quality, real-world retrospective data to accelerate the FDA process for pediatric labeling of this life-saving device, which improves survival rates for children facing end-stage heart failure.

ACTION leadership advocated for FDA approval of the device, gathering foundational data and enhancing clinical knowledge around VADs for pediatric use. Prior to this announcement, the HeartMate 3™ LVAD was only available to children off-label. Families, caregivers, children and medical providers can now take heart and celebrate our robust grassroots efforts to improve the accessibility of this device by catalyzing its expanded FDA labeling.

As the leading nationwide network of providers and families devoted to improving critical outcomes for children with heart failure, ACTION is collaborating with industry to bring safer, better therapies to pediatric patients in need. This announcement is a once-in-a-decade achievement, as the most recent VAD to be approved in children was the Berlin Heart EXCOR® in 2011. Together, we are bringing hope to children and those who love and care for them. 

“Our mission is to improve the outcomes for children with heart failure. Historically, this has been an underfunded and understudied area in pediatrics,” say Angela Lorts, MD, MBA and David Rosenthal, MD, Co-Founders of ACTION. “This device approval is a leap forward for improving heart failure outcomes in children. We were honored to collaborate with Abbott on the FDA approval process and we look forward to future industry collaborations to move the field forward.”

The announcement comes just weeks after ACTION launched its groundbreaking patient and caregiver education site, My ACTION Education. The site features engaging animations, infographics and articles that help children, parents and caregivers better understand heart failure and explore their treatment options. ACTION invites everyone to “Join the ACTION’ by creating an account on the new site and learning more about Abbott’s HeartMate 3™ LVAD, plus many other devices and treatment options available to children diagnosed with heart failure. Clinicians and providers are also invited to join ACTION and advance clinical knowledge in pediatric heart failure.

Together, we are moving the field forward and bringing hope to thousands of children living with heart failure.