Medical device company HeartWare International has obtained the US Food and Drug Administration (FDA) approval to enrol an additional patient cohort in the pivotal destination therapy trial, ENDURANCE.
In addition to 286 patients receiving the HeartWare ventricular assist system, the company will also enrol an additional 143 control patients using a randomisation scheme consistent with the ENDURANCE protocol.
Patient enrolment in this supplemental cohort can begin at the 50 centres participating in the ENDURANCE trial, following Institutional Review Board approvals at each of the centres.
The protocol for this cohort was amended to include enhanced blood-pressure monitoring to ensure optimal patient management.
The patients enroled in the study will be followed for 12 months after implant.
The company is currently planning to use the clinical data from this new cohort and ENDURANCE trial for pre-market approval (PMA) of HeartWare system indicated for the destination therapy.
In November 2012, HeartWare system received the FDA's clearance for the bridge-to-transplant indication.
In parallel to this approval, the company also commenced a post-approval study (PAS) to assess device performance in real-time settings.
HeartWare's PAS registry comprises 600 patients who received 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 to complete enrolment for both arms of the PAS by end of the year.
The HeartWare ventricular assist system consists of the HVAD pump, which is a small full-support circulatory assist device designed to be implanted next to the heart. It helps evade the abdominal surgery generally required to implant competing devices.
The HeartWare system received CE marking in the European Union and has been used to treat patients in 35 international countries.
According to GlobalData estimates, ventricular assist devices market in the US, which was valued at $417.8m in 2012 is expected to grow at a CAGR of 14% to reach $1.04bn by 2019.
Image: HeartWare ventricular assist system. Photo: courtesy of HeartWare International, Inc.