HeartWare Completes Enrollment in Endurance2 Trial
Framingham, Mass., devicemaker HeartWare has finished enrolling patients in the Endurance2 clinical trial of its HeartWare Ventricular Assist System, evaluating patients implanted with the device for long-term use.
In all, 465 patients were enrolled at 50 participating hospitals between October 2013 and August of this year. The study’s primary endpoint — incidence of neurologic injury at 12 months post-implantation — will be evaluated for inferiority versus an alternative FDA-approved left ventricular assist device.
Data from the trial will be used to support a submission seeking FDA approval of the HeartWare VAS for destination therapy in patients with end-stage heart failure who are ineligible for heart transplantation.
The FDA approved the device in 2012 as a bridge to heart transplantation in patients at risk of death from refractory end-stage left ventricular heart failure. It is also available in the EU and Australia. — Meg Bryant