Abbott has announced that the US Food and Drug Administration (FDA) has approved updated labelling for the company’s HeartMate 3 heart pump to be used in paediatric patients with advanced refractory left ventricular heart failure. With the updated labelling, physicians now have additional options for treating this underserved population awaiting a heart transplant or for those not eligible to receive a transplant as a result of potential complications or risk related to the procedure.
The approval follows similar paediatric innovations for Abbott in recent years, including the Masters HP, a 15mm pediatric heart valve, approved in 2018; and the Amplatzer Piccolo Occluder, approved in 2019 to help treat a potentially life-threatening opening in the heart of some premature or new-born babies.
Many children and adolescents with congestive heart failure require a heart transplant or mechanical device implant to survive. The HeartMate 3 left ventricular assist device (LVAD) is an implantable device that pumps blood through the body in people whose heart is too weak to do so on its own.
The HeartMate 3 pump was initially approved in the USA in 2017 for adults awaiting a heart transplant and received FDA approval for long-term use in adults in 2018. In the largest LVAD trial in the world, the HeartMate 3 pump showed a survival rate of 79% at two years, an outcome comparable to patients receiving a heart transplant.
“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,” said Robert L. Kormos, divisional vice president, global medical affairs, Abbott’s heart failure business. “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.”