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The FDA approved the HeartWare HVAD System for destination therapy in patients with advanced heart failure who are not candidates for heart transplants, Medtronic .
The centrifugal-flow left ventricular assist device was previously only for bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.
The expanded indication was based on results from the ENDURANCE and ENDURANCE Supplemental trials' in nearly 1,000 destination-therapy patients.
In ENDURANCE, 455 advanced heart failure patients who were not candidates for heart transplantation were randomized to the HeartWare or HeartMate II LVAD. The primary endpoint showed noninferiority of HeartWare for survival 2 years after implantation without disabling stroke or device malfunction leading to LVAD removal (55.4% versus 59.1%), but there were significantly more strokes, right heart failure onset, and sepsis.