November 17, 2010 – Data from the ADVANCE bridge-to-heart-transplant study showed that 92 percent of patients were either alive on the implanted device, had a heart transplant or explanted for recovery. The study looked at the HeartWare Ventricular Assist System at 180 days.
Between August 2008 and February 2010, 140 patients at 30 U.S. hospitals received the device, which has been approved by the U.S. Food and Drug Administration (FDA) as an IDE.
"Implantation of the investigational device was associated with a high probability of success at 180 days. We observed marked improvement in two heart failure specific and two generalized quality of life measures from initial patient baseline," said Keith Aaronson, M.D. M.S., co-principal investigator of the study. "HeartWare patients were able to walk 113 meters farther in six minutes when tested three months after surgery and patient assessment of their own quality of life more than doubled. The adverse event profile from the trial data appears to be favorable, with observed bleeding, infection and ventricular arrhythmia rates at relatively low levels."
"Investigators found that the small device size, with implantation in the pericardial space adjacent to the heart, reduced the complexity of the implant procedure," said Mark Slaughter, M.D., co-principal investigator, professor and chief in the division of thoracic and cardiovascular surgery, and director of the mechanical assist device and heart transplant program at the University of Louisville in Louisville, Ky. "These device attributes and overall performance help account for the acceleration of enrollment rate we observed during the ADVANCE study."
The system is a small full-output circulatory support device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. The HVAD pump weighs approximately five ounces and displaces a volume of approximately 50 milliliters.
For additional information: www.heartware.com