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.
The company claimed that after more than 1,300 artificial
heart implants that involved more than 5,000 of the valves, not one failure has
"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.