BiVACOR, an international medical device company with headquarters in the United States and Australia, has received approval from the U.S. Food and Drug Administration (FDA) to kick off an early feasibility study (EFS) for its total artificial heart (TAH) technology.
The BiVACOR Total Artificial Heart is intended to be a bridge for heart failure patients waiting to receive a full heart transplant. The device, based on rotary blood pump technology, is approximately the size of an adult’s fist. While it was designed to support an adult male who is actively exercising, it is also small enough that women and some pediatric patients could potentially receive the device.
According to BiVACOR, the TAH uses the same technology seen in high-speed trains. Its only moving part is a magnetically suspended double-sided centrifugal pump impeller. The device’s non-contact suspension has two primary benefits: limiting blood trauma to prevent hemolysis and reducing the risk of mechanical wear.