December 17, 2020 – Abbott (Abbott Park, IL) announced that the U.S. Food and Drug Administration (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 company says.
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 U.S. in 2017 for adults awaiting a heart transplant and received FDA approval for long-term use in adults in 2018.
Abbott’s HeartMate 3 heart pump is a small, implantable mechanical circulatory support device for advanced heart failure patients who are awaiting transplantation or are not candidates for heart transplantation. It is the first commercially approved (CE Mark and FDA approved) heart pump with Full MagLev technology, which allows the device’s rotor to be “suspended” by magnetic forces. This design aims to reduce trauma to blood passing through the pump and improve outcomes for patients.
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.
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.