Abbott (NYSE:ABT) announced that the FDA approved updated labeling for its HeartMate 3 heart pump for pediatric patients.
The heart pump can now be used in pediatric patients with advanced refractory left ventricular heart failure, giving physicians more options for treating the pediatric population awaiting a heart transplant or ineligible for receiving a transplant due to complications, according to a news release.
HeartMate 3 initially received U.S. approval in 2017 for adults awaiting a heart transplant, then it received long-term use approval for adults in 2018. The left ventricular assist device (LVAD) is implanted to pump blood through the body for those who have hearts too weak to do so in their own.
Abbott Park, Ill.-based Abbott said the updated labeling follows a trend of pediatric innovations for the company, with its Masters HP heart valve approved in 2018 and its Amplatzer Piccolo occluder cleared in 2019, both for pediatric populations.
“For families with children battling chronic diseases the future is often bleak. As physicians, we see the fear in the eyes of not only the child, but also the mothers and fathers,” divisional VP of global medical affairs in Abbott’s heart failure business Dr. Robert L. Kormos said in the release. “Imagine a child with a heart condition that does not allow them to play with friends, sing or run. Innovations, such as the HeartMate 3, can lessen the crippling effects of heart failure and allow that child to live a more normal life.”