
HeartWare International (NSDQ:HTWR) completed enrollment in a 450-patient pivotal trial considering its ventricular assist system as a destination therapy for patients with advanced heart failure.
The Endurance randomized, controlled, multi-center trial will meet its primary endpoint with 2 years of follow-up, with subsequent follow-up extending to 5 years. The company plans to ask FDA permission to extend the trial to additional patients through the federal watchdog agency’s "continued access protocol" pathway.
HeartWare researchers hope to find patients alive and without debilitating strokes, having survived long enough to receive a heart transplant or having recovered and no longer needing the device, according to a press release.
"Completing enrollment in this, the largest head-to-head ventricular assist device clinical trial to date, is a major achievement and we look forward to following this destination therapy patient population to primary endpoint over the next 2 years," HeartWare president & CEO Doug Godshall said in prepared remarks. "With enrollment of the study complete, we are pleased to report that more than 2,000 end stage heart failure patients globally have received the HeartWare ventricular assist system."
The HeartWare HVAD is currently also under FDA review as a bridge-to-transplant therapy for advanced heart failure patients. An FDA expert advisory panel late last month recommended approval for the HVAD implantable heart pump for people with end-stage heart failure.
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