HeartWare International has received the U.S. Food and Drug Administration (FDA) approval to enroll supplemental patient cohort for ENDURANCE, a pivotal destination therapy clinical study.
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 patients enrolled in the study will be followed for one year after implant.
This new protocol includes enhanced blood pressure monitoring to ensure optimal patient management.
The company is planning to use the data from both this new cohort and ENDURANCE for pre-market approval (PMA) of HeartWare system for the destination therapy indication.
The new cohort's protocol is designed to confirm that lower incidence of neurological events was noticed in clinical sites adhering to stringent monitoring and management of patient blood pressure.
Following the approvals from Institutional Review Board, patient enrollment will begin at the 50 centers participating in the ENDURANCE clinical trial.
In November 2012, HeartWare system received the FDA's clearance for the bridge-to-transplant indication.
The HeartWare system received CE mark in the European Union and is currently available in 35 international countries.