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Monday, February 8, 2021

FDA Approves Labeling Update for Abbott’s HeartMate 3 Heart Pump for use in 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.

 

Heart Mate 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 Heart Mate 3, can lessen the crippling effects of heart failure and allow that child to live a more normal life.”

Many children and adolescents with congestive heart failure require a heart transplant or mechanical device implant to survive. The Heart Mate 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 Heart Mate 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 Heart Mate 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, M.D., 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 Heart Mate 3, can lessen the crippling effects of heart failure and allow that child to live a more normal life."

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FDA Approves Labeling Update for Abbott’s HeartMate 3 Heart Pump for use in Pediatric Patients

  The heart pump can now be used in pediatric patients with advanced refractory left ventricular heart failure, giving physicians more opti...