What is the project focus?
We used the ACTION registry to collect data on children implanted with the HeartMate 3TM LVAD (Abbott). This allowed for a review of device safety and outcomes. The new FDA label will lead to improved device availability for children everywhere.
See the December 17, 2020 press release FDA Expands Labeling of Abbott’s HeartMate 3™ LVAD for Pediatric Use with Collaboration from ACTION to learn more about how our ACTION centers collaborated with Abbott to update FDA labeling for the HeartMate 3™ LVAD for use in pediatrics.
Who is impacted?
All pediatric heart failure patients will be impacted by the use of real-world data to get advanced cardiac therapies to the bedside.
What are we doing to help?
ACTION is collaborating with many organizations to achieve the best care for children in heart failure. This includes getting both medicines and devices to children, when appropriate.