Bivacor has eliminated the valves, flexing ventricle chambers, pumping diaphragms and mechanical bearings used in other designs of total artificial heart. The titanium device houses a magnetically suspended rotor that sends pulses of blood around the body. The rotor is the device’s only moving part. A cord connects the device to either a portable power source or the mains.
Last year, Bivacor tested the device in five patients in the U.S. in an early feasibility study. The artificial heart supported the patients for up to one month while they waited in hospital for a donor heart. All the patients received a donor heart and were discharged from the hospital.
Later, a man in Australia had the device for 105 days while he waited for a donor heart. The man was the first person with the device to be discharged from the hospital while he waited for a heart transplant. When a heart became available, the patient underwent a successful transplant procedure.
The FDA cleared Bivacor to enroll a further 15 patients in its early feasibility study after seeing data from the first five people treated in the trial. Bivacor said it plans to start the expanded study later this year. The breakthrough designation positions the company to receive priority regulatory interaction with the FDA as it works to bring the device to market.
