HeartWare International (NSDQ:HTWR) won an Investigational Device Exemption (IDE) supplement from the FDA to add another patient group to its ongoing ENDURANCE trial, this time examining the impact of blood pressure monitoring on neurological outcomes.
Researchers are evaluating the use of the HeartWare’s ventricular assist device (VAD) as a final or destination therapy for heart failure patients who are too sick for a heart transplant and have not responded to other therapies. The device is already approved in the U.S. as a bridge to cardiac transplantation, the Framingham, Mass.-based company noted.
This news comes on the heels of a shakeup of HeartWare’s stock after a financial analyst cited "glaring inconsistencies" between statements made by a principal investigator for the ENDURANCE trial for VAD as destination therapy and remarks made by the company’s CEO on calls with financial analysts.
The FDA in June granted HeartWare conditional approval for an expansion of ENDURANCE to evaluate the effect of closer blood pressure monitoring on neurological events. The newest patient group is intended to help confirm clinical observations that more regular monitoring and management of patient blood pressure results in fewer neurological events, according to a press release.
HeartWare won permission to enroll up to 286 VAD patients as well as up to 143 control patients in the new supplemental group, and the company plans to follow them for 12 months following implant. Data from both this new group and ENDURANCE will be incorporated into HeartWare’s anticipated pre-market approval application for the device.
In addition to U.S. approval as a bridge to transplant therapy, the HeartWare VAD has a CE Mark in Europe, and has been used to treat patients in 35 countries, the firm said. HeartWare added that it expects to complete enrollment for the post-approval study of 600 patients for HVAD as a bridge to cardiac transplantation by the end of this year.
HTWR shares ticked up 0.6% today to $80.79 apiece as of about 12:45 p.m.
