The FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee voted 9-2 that the benefits of the HeartWare Ventricular Assist System outweigh the risks when used in the appropriate patient population.
“I feel this device has great promise. It does represent a lot of technical advances over existing technology,” Gregory Dehmer, MD, of Scott & White Healthcare and Texas A&M University, said. “I believe that the sponsor has met the basic question of showing that the device is effective. The safety data are a little questionable, but I think, in the totality of all data, I am reasonably assured that it’s safe to move forward.”
The committee discussed results from the Evaluation of the HeartWare System for the Treatment of Advanced Heart Failure Trial (ADVANCE), which used an external contemporaneous control group from the Inter-Agency Registry for Mechanical Assisted Circulatory Support (INTERMACS) and enrolled 160 patients, 143 of whom had the HeartWare Ventricular Assist Device implanted. These results showed that patients implanted with the HeartWare System experienced survival rates of greater than 90% at 180 days, as well as improvement in quality of life and functional capacity.
Although throughout the meeting the panel seemed unsure whether data from ADVANCE provided sufficient evidence for the vote, the panel voted 8-3 that the device was safe and 11-0 that the device was effective.
During the meeting, David Slotwiner, MD, of Long Island Jewish Medical Center, said, “There were some holes in the safety data, but I think, overall, this is a novel device for a desperate population and I really hope it’s available soon.”
However, some panel members, including Scott Evans, PhD, of the Harvard School of Public Health, expressed concern, noting that key variables were missing from the ADVANCE trial.
An electrically powered centrifugal-flow rotary blood pump with external driver and power sources, the HeartWare Ventricular Assist System is the first ventricular assist device that does not require the creation of an abdominal pump pocket. It is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory, advanced HF. The device received CE mark in January 2009.
Although the FDA is not required to follow the recommendations of the advisory committee, it usually does.