FDA Approves Freedom Portable Driver Powering SynCardia Total Artificial Heart
The Freedom portable driver is U.S. Food and Drug Administration (FDA)-approved for use with the SynCardia temporary total artificial heart as a bridge to transplantation in cardiac transplant candidates who are clinically stable.
The 13.5-pound Freedom driver can be carried in a backpack, shoulder bag, walker or a rolling caddy. It powers the total artificial heart with precisely calibrated pulses of air and a small amount of vacuum so that the diaphragm is in the proper position to accept the next filling of blood into each artificial ventricle.
Like a heart transplant, the SynCardia total artificial heart is designed to eliminate the source of end-stage biventricular failure by replacing both failing ventricles and the four heart valves of a patient.
The Freedom runs on lithium-ion batteries that are re-charged using a standard electrical outlet or a car charger that can be used in autos and many boats.
The Freedom was approved in Europe in March 2010 and in Canada in May 2011.
For more information: www.syncardia.com