A new kind of artificial heart that combines synthetic and biological materials as well as sensors and software to detect a patient’s level of exertion and adjust output accordingly 
is to be tested in patients at four cardiac surgery centers in Europe and the Middle East. If the “bioprosthetic” device, made by the Paris-based Carmat, proves to be safe and effective, it could be given to patients waiting for a heart transplant. Currently, only one fully artificial heart, made by Tucson, Arizona-based SynCardia, has U.S., Canadian, and European regulatory approval for use in patients.
Attempts to completely replace the human heart with a prosthetic device started decades ago (see “CPR for the Artificial Heart”). It is hugely challenging to create a device that can withstand the harsh conditions of the body’s circulatory system and reliably pump 35 million times per year, as the heart does. Other complications, such as stroke caused by blood clots in artificial heart implants, have also caused setbacks. For these reasons, fully artificial hearts typically serve as a temporary measure, or as a “bridge to transplant,” although the FDA has recently granted a humanitarian use exemption for one of SynCardia’s artificial hearts for patients not currently eligible for a donor heart.
