The FDA has granted a breakthrough device designation to the BiVACOR Total Artificial Heart. Made of titanium, the device uses a magnetically levitated rotor to pump blood in adult patients with severe heart failure.
Though not approved for commercial use, the breakthrough device designation supports use of the device as a bridge to heart transplant, according to a May 30 news release from BiVACOR.
As part of an early feasibility study, five U.S. patients have survived on the artificial heart while waiting for a donor heart. The implantations were performed by teams at Houston-based Texas Heart Institute, Durham, N.C.-based Duke University Hospital, Banner-University Medical Center Phoenix and Cincinnati-based The Christ Hospital between July and November.
The FDA has since expanded the study to 20 patients, according to a Dec. 18 news release from the company.
An Australian man lived with the device for 100 days, including a period out of hospital, before receiving a donor heart transplant in March.
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