The FDA has granted HeartWare a continued access protocol for its investigational device exemption, which will allow the company to enroll additional patients into a clinical trial that is studying the efficacy of its Ventricular Assist System on patients with end-stage heart failure.
According to Framingham, Mass.-based HeartWare, its ADVANCE bridge-to-transplant clinical trial will now enroll an additional 54 patients, pending IRB approval.
Thus far, the trial has implanted 140 patients at 30 clinical sites across the U.S. with the HeartWare HVAD pump. ADVANCE will look at 180-day mortality rates and adverse events—bleeding, infection, hospitalization, neuro-cognitive function and quality of life.
The HeartWare system includes the HVAD pump, a small circulatory support device that provides up to 10L/min flow and is implanted next to a patients heart, alleviating the need for abdominal surgery.
HeartWare expects to submit the appropriate forms to the FDA to gain approval for the HeartWare system as an indication to be used as a bridge-to-transplant device.
The HeartWare ventricular assist system has already received a CE mark of approval in Europe, the company said.