Abbott gets FDA approval for HeartMate 3 pump

Abbott has received the US Food and Drug Administration approval of a new alternative surgical technique for its HeartMate 3 left ventricular assist device (LVAD). HeartMate 3 LVAD is a small, implantable mechanical circulatory support device, designed for advanced heart failure patients requiring transplantation.

The company said that the new surgical technique will help the heart failure patients by preventing open heart surgery, and enables surgeons to choose the surgical method using its HeartMate 3 LVAD. Traditional heart pumps are implanted through open-heart surgery. Through the alternative surgical technique, HeartMate 3 heart pump can be implanted through lateral thoracotomy, a surgical approach to access the heart through an incision between ribs. The new less invasive surgical technique is thought to be more effective than open heart surgery, resulting in less bleeding and shorter recovery time for many patients.

The regulatory approval is supported by the clinical trials ELEVATE, and the LAT Feasibility study. According to the results of the clinical studies, the less-invasive surgical approach demonstrated lower bleeding, infection and arrhythmias in patients, compared to open-heart surgery.