The device, which is made of titanium and uses a magnetically levitated rotor to pump blood, is designed to serve as a “bridge” for patients waiting for a donor heart. Five patients — four in the U.S. and one in Australia — have successfully received the BiVACOR Total Artificial Heart as part of an FDA early feasibility study.
The FDA has authorized a 20-person early feasibility study.
On Nov. 22, a clinical team at St. Vincent’s Hospital Sydney transplanted the artificial heart into a man in his 40s from New South Wales. After a few weeks in the ICU and under observation, the hospital discharged the patient. He lived for 100 days — the longest period to date with the device — before receiving a donor heart transplant in early March.
The patient is recovering well, according to St. Vincent’s Health Australia.
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