FDA approves labeling update for Abbott's HeartMate 3 heart pump for use in pediatric patients.

Abbott has announced the FDA has approved updated labeling for the company's HeartMate 3 heart pump to be used in pediatric patients with advanced refractory left ventricular heart failure. With the updated labeling, 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 pediatric innovations for Abbott in recent years, including the Masters HP, a 15mm pediatric heart valve the size of a dime, approved in 2018; and the Amplatzer Piccolo Occluder, a pea-sized plug approved in 2019 to help treat a potentially life-threatening opening in the heart of some premature or newborn 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) – or heart pump – 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 United States 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.