HeartWare To Commence Enrollment In Additional Patient Cohort For ENDURANCE

(RTTNews) - HeartWare International Inc. (HTWR) announced the U.S. 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.

HeartWare intends to incorporate the data from both the new cohort and ENDURANCE into an anticipated Pre-Market Approval Application seeking approval of the HeartWare System for the Destination Therapy indication. On November 20, 2012, FDA granted approval of the HeartWare System for the Bridge-to-Transplant indication.

In the supplemental cohort, HeartWare will enroll up to 286 patients receiving the HeartWare Ventricular Assist System, as well as up to an additional 143 control patients using a randomization scheme consistent with the ENDURANCE protocol. 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.