SynCardia (Tucson, AZ) has gained FDA approval for its SynCardia Total Artificial Heart with SynHall valves, the last of the approvals required to manufacture the hearts for sale in the U.S. The approval was given on July 2, 2104.
The device has recently been approved in Canada and Europe. The SynHall valves, made of titanium and pyrolytic carbon, are nearly identical to the tilting-disk valves used with the Total Artificial Heart in the past.
AdvertisementThe company claimed that after more than 1,300 artificial heart implants that involved more than 5,000 of the valves, not one failure has been reported.
"We're delighted that the SynHall valves passed the FDA's rigorous approval process," says Michael P. Garippa, SynCardia CEO and President.
The company also controls manufacture of segmented polyurethane solution (SPUS), which is used in the SynCardia Total Artificial Heart's housings, diaphragms and connectors. SynCardia is the only source of SPUS in the world.
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