TUCSON, Ariz. — 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.
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About the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. in Tucson, Arizona is the privately-held owner and manufacturer of the world’s first and only FDA, Health Canada and CE approved Total Artificial Heart.
Originally used as a permanent replacement heart, the SynCardia Total Artificial Heart is currently approved as a bridge to transplant for people suffering from end-stage biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive.
More than 1,300 implants of the SynCardia Total Artificial Heart accounts for over 400 patient years of life on the device. Since January 2011 more than 400 SynCardia Hearts have been implanted.
SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to leave the hospital to live at home and in their communities. The wearable Freedom driver has been used by 175 patients, accounting for over 100 years of support.
Press release via Syncardia.
