The approval is the latest for the HeartMate line of left ventricular assist devices first developed by Thoratec, which was later acquired by St. Jude Medical before a $25 billion merger brought it to Abbott earlier this year.
Abbott said HeartMate 3 features full magnetic levitation for the pump’s impeller, aiming to cause less trauma to blood cells as they pass through the pump. Although it is smaller than its predecessor, Abbott claimed it has the industry’s largest “pump pathway.” The device won CE Mark approval in the European Union in October 2015.
“Heart failure is a crippling and costly disease and the HeartMate 3 system is a big stride forward in giving patients the opportunity to return to better quality lives. Abbott is the pioneer and global leader in LVAD therapy and offers the broadest heart failure portfolio on the market to help physicians manage their patients from early to end-stage heart failure,” cardiac arrhythmias & heart failure CMO Dr. Mark Carlson said in prepared remarks.
“In the Momentum 3 study, the HeartMate 3 system had no instances of suspected or established blood clotting within the pump at six months, which is a major milestone for those of us working tirelessly to improve clinical outcomes for patients living with advanced heart failure,” added Dr. Mandeep Mehra of Boston’s Brigham & Women’s Hospital.
In June Abbott warned physicians about a potential communication problem with the HeartMate 3 device, based on “limited” reports of communication errors between the system controller and the pump itself.