FDA approves updated labeling for LVAD use in pediatric HF
Abbott announced the FDA approved updated labeling for its implantable heart pump for use in pediatric patients with advanced refractory left ventricular HF.
Abbott's left ventricular assist device (HeartMate 3) is a small, implantable mechanical circulatory support device for patients with advanced HF who are awaiting heart transplantation or are not candidates for it.
The updated labeling was supported by clinical data from the Advanced Cardiac Therapies Improving Outcomes Network Learning Collaborative, a consortium of more than 50 U.S. pediatric hospitals that pooled data to demonstrate positive outcomes of the LVAD in pediatric patients, according to a press release from the company.
According to the release, the product is the first commercially approved LVAD that uses magnetic forces to suspend the device's rotor to reduce trauma to blood passing through the pump and improve outcomes.
"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," Robert L. Kormos, MD, divisional vice president of global medical affairs for Abbott's heart failure business, 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."