SynCardia Systems, Inc. received approval July 2, 2014 from the United States Federal Drug Administration (FDA) for the SynCardia temporary Total Artificial Heart with SynHall™ valves, giving the company control over the last key component to manufacture the Total Artificial Heart.
FDA approval follows SynCardia's receipt of the CE Mark for European use of the SynHall valves only in the SynCardia Total Artificial Heart on April 17, 2014. Health Canada approval was received for the same purpose on July 28, 2014.
The SynHall valves only for use in the SynCardia Heart are of the same design, materials and nearly identical manufacturing processes as the tilting-disk valves that have always been used in the Total Artificial Heart.
Made of titanium and pyrolytic carbon, these robust valves have never failed in more than 1,300 implants of the SynCardia Total Artificial Heart, accounting for well over 5,000 valves and over 30 years of use.
"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.