News | September 05, 2013

FDA Grants HeartWare Supplemental Patient Cohort In Destination Therapy Trial

September 5, 2013 — HeartWare International Inc. announced that the U.S. Food and Drug Administration (FDA) has approved an IDE (Investigational Device Exemption) Supplement that allows HeartWare to commence enrollment in an additional patient cohort for ENDURANCE, the company's pivotal, destination therapy clinical study.

In this supplemental cohort, HeartWare will enroll up to 286 patients receiving the HeartWare ventricular assist device (VAD) system, as well as up to an additional 143 control patients using a randomization scheme consistent with the ENDURANCE protocol. Patients will be followed for 12 months after implant. HeartWare intends to incorporate the data from both this new cohort and ENDURANCE into an anticipated pre-market approval (PMA) Application seeking approval of the HeartWare System for the destination therapy indication.

The protocol for this cohort is designed to confirm clinical observations that sites adhering to more regular monitoring and management of patient blood pressure witnessed a notably lower incidence of neurological events.

Patient enrollment can commence at the 50 centers participating in the ENDURANCE clinical trial, following Institutional Review Board approvals at each of the centers.

On Nov. 20, 2012, the FDA granted approval of the HeartWare System for the Bridge-to-Transplant indication. Concurrent with approval, the company commenced a post-approval study (PAS) to assess device performance in a real-world setting. HeartWare's PAS is a registry consisting of 600 patients who receive an HVAD and an additional 600 control patients derived from a contemporaneous group of continuous flow, intra-corporeal LVAD patients entered into the INTERMACS database. HeartWare expects enrollment for both arms of the PAS will be complete by year's end.

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