HeartWare International (NSDQ:HTWR) said the FDA granted conditional approval for an expansion of the Endurance clinical trial to evaluate the effect of closer blood pressure monitoring on neurological events.
The Framingham, Mass.-based medical device company said the new arm of the study aims to "confirm observations from Endurance that sites adhering to more regular monitoring and management of patient blood pressure witnessed a notably lower incidence of neurological events," according to a press release.
The FDA nod means HeartWare can add another 360 patients to the 450-patient Endurance trial, which is examining the use of the HeartWare ventricular assist device as a destination therapy for heart failure patients who are too sick for a heart transplant.
"HeartWare intends to incorporate the data from this new cohort into an anticipated pre-market approval application seeking approval of the HeartWare System for the destination therapy indication," according to the release. "Patient enrollment in this supplemental cohort can commence at the 50 centers participating in the Endurance clinical trial, following edits to the protocol as prescribed by FDA and Institutional Review Board approvals at each of the centers."
HTWR shares ticked up 0.7% this morning to $92.00 apiece as of about 10:40.