HeartWare Achieves Primary Endpoint In The ENDURANCE Clinical Trial

(RTTNews) - HeartWare International Inc. (HTWR) said that data from its first destination therapy clinical trial cohort, ENDURANCE, successfully demonstrated that the trial achieved the primary endpoint.

HeartWare said its ENDURANCE clinical trial is a prospective, randomized, controlled, un-blinded Investigational Device Exemption or IDE study designed to evaluate the HeartWare Ventricular Assist System as a destination therapy - or long-term therapy - for patients with end-stage heart failure who are ineligible for heart transplantation.

Between August 2010 and May 2012, 446 patients were enrolled at 48 U.S. hospital centers and were randomly selected to receive either the HeartWare Ventricular Assist System or, as part of a control group, any alternative Left Ventricular Assist Device or LVAD approved by the U.S. Food and Drug Administration or FDA for Destination Therapy, in a 2:1 ratio.

Investigators for the study reported that 55.0% of the investigational device patients attained the primary endpoint of the trial, which is stroke-free survival at two years, defined as alive on the originally-implanted device, transplanted or explanted due to patient recovery. In comparison, 57.4% of patients in the control arm achieved the primary endpoint of the study.  Based on these results for the primary endpoint of the ENDURANCE study, non-inferiority of the investigational device was established.

The company noted that secondary endpoints for ENDURANCE include adverse events such as bleeding and infection, as well as functional status, assessment of neuro-cognitive function and patient quality of life.