The FDA has given HeartWare an investigational device exemption (IDE) supplement to allow the company to start enrolment in an additional patient cohort for its ENDURANCE study, which is evaluating the company’s ventricular assist system as a destination therapy for heart failure patients. The system is already FDA-approved as a bridge-to-translation therapy.
According to a press release, HeartWare will enrol up to 286 patients receiving its ventricular assist system, as well as up to an additional 143 control patients using a randomisation 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 application seeking approval of the HeartWare system for the destination therapy indication.
The press release states that the protocol for this new 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 enrolment can commence at the 50 centres participating in the ENDURANCE clinical trial, following institutional review board approvals at each of the centres.