FDA Approves Abbott’s HeartMate 3 Implantable Pump
Abbott received 510(k) clearance for the HeartMate 3 implantable pump for heart failure patients awaiting a transplant.
The approval is the latest for the HeartMate line of left ventricular assist devices first developed by Thoratec. Thoratec was brought to Abbott in a $25 million merger earlier this year after they were acquired by St. Jude Medical.
The device features full magnetic levitation for the pump’s impeller, aiming to cause less trauma to blood cells as they pass through the pump. The device won CE Mark approval in the European Union in October 2015.