FDA approves Abbott’s new less-invasive LVAD techMarch 6, 2020
The US FDA has approved a new alternative surgical technique for HeartMate 3 pump that will allow more advanced heart failure patients to avoid open-heart surgery.
The new, less invasive approach is designed to provide surgeons a choice in surgical method for patients receiving the HeartMate 3 Left Ventricular Assist Device (LVAD), Abbott said.
The approval is based on two studies – the ELEVATE study: a multi-centre, voluntary, observational registry collecting post-marketing data, and the LAT Feasibility study: a single-arm, prospective, multicentre study.
Results of the two trials found that bleeding (requiring surgery), infection and arrhythmias were lower in the group implanted via the less-invasive surgical approach than those who underwent open-heart surgery.
The HeartMate 3 received approval from the FDA in 2017 for patients with advanced heart failure whose hearts are unable to circulate blood through the body, and are waiting for a transplant, known as the bridge to transplant.