Product Pipeline.

Product Pipeline

Thoratec gets OK for Heartmate II IDE trial

In what could be seen as a coup, ventricular assist device maker Thoratec (Pleasanton, California) reported last month that the FDA granted it a virtually condition-free approval of its investigational device exemption (IDE) for the company to begin a Phase II pivotal clinical trial for its next generation HeartMate II LVAS (Left Ventricular Assist System). The system is designed to provide long-term cardiac support for patients who are in end-stage heart failure.

The study incorporates a number of unique elements, including the use of the device for both bridge-to-transplantation (BTT) and destination therapy (DT), the first time the FDA has approved a clinical trial with both indications in one protocol, Thoratec said.

The company is in the process of identifying prospective centers beyond those 10 that participated in the Phase I study. Initial patient enrollment could begin within 30 days, pending appropriate approvals within the hospitals, the company said.

A unique aspect of the BTT study design is that the control group will be comprised of data from previous clinical trials and concurrent data from the companys voluntary VAD implant registry, enabling a non-randomized trial design in which all subjects will receive the HeartMate II. The BTT arm of the study will involve 133 patients at up to 25 centers with the primary endpoint being the rate of survival to transplantation, or 180 days.

Secondary endpoints include adverse events, device reliability, quality of life and functional status. The company noted that it has already enrolled 25 patients in the Phase I portion of the BTT trial, leaving 108 patients to be accrued in the Phase II pivotal study.

The DT arm of the study will involve 200 total patients, randomizing the HeartMate II to the currently approved system, the HeartMate XVE on a 2-1 basis, respectively. The study provides for a composite two-year endpoint, which includes patient survival, rate of neurological events and device reliability.

Secondary endpoints …