Thoratec Receives Approval for Phase II HeartMate II LVAS Trial

Thoratec has said the FDA granted approval of its investigational device exemption for the company to begin a Phase II pivotal clinical trial for the HeartMate II LVAS (left ventricular assist system).

The HeartMate II is a next generation heart-assist device 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 and destination therapy, the first time the FDA has approved a clinical trial with both indications in one protocol, the company 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 only condition of the FDA approval is that the company establish an independent, blinded clinical endpoint committee to review adverse events occurring in the study.