Artificial hearts like the SynCardia Total Artificial Heart require a good deal of continuous, clean power to have them running day and night. That’s why patients had to spend their time in the hospital hooked up to a special driver while waiting for a donor organ to arrive. Now SynCardia (Tucson, AZ) is making available its Freedom portable driver in the U.S., thanks to a newly obtained FDA approval.
Unlike the Big Blue driver that wouldn’t even fit into a car’s trunk, the Freedom can be carried in a backpack, hanging off a walker, or however else is handy. It weighs a reasonable 13.5 lbs (6.1 Kg) and runs on two hot-swappable lithium-ion batteries that can be recharged from a standard electrical outlet or from a car’s cigarette lighter. The device received extensive trialing with patients at 22 centers and involved 106 patients to evaluate whether it is practical to use the Freedom to discharge patients home or to step-down facilities.
The device received European regulatory approval already more than four years ago.
From the announcement:
Those 106 patients received 58 total years of support starting when they were first switched to the Freedom portable driver in the U.S. study. The SynCardia Total Artificial Heart with the Freedom Drive System allowed 75% of those patients to be discharged from the hospital, while 86% of the 106 patients either were bridged to heart transplants or were alive and supported by the SynCardia Total Artificial Heart and the Freedom driver as of June 30, 2014.
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.