SynCardia Total Artificial Heart
with SynHall Valves Receives CE Mark
CE Mark Gives SynCardia Systems, Inc. Control over Last Critical Component for SynCardia Heart Manufacturing
TUCSON, Ariz. – May 13, 2014 – On April 17, 2014, SynCardia Systems, Inc. received the CE Mark for the SynCardia temporary Total Artificial Heart with SynHall™ valves, providing the company with control over the last key component required for heart manufacturing.
The SynHall valves for use only as part of the SynCardia Total Artificial Heart have the same design, materials and nearly identical manufacturing processes as the tilting-disk valves that have always been used in the Total Artificial Heart.
SynCardia has made applications for similar approvals to FDA and Health Canada regulatory bodies and approval of the SynCardia Total Artificial Heart with the SynHall valves are hopefully anticipated for later this year.
These robust valves of titanium and pyrolytic carbon have never failed in more than 1,300 implants of the SynCardia Heart, accounting for well over 5,000 valves and over 30 years of use.
“With the CE Mark for SynCardia Total Artificial Heart with SynHall valves, we control the last of two key components required for SynCardia Heart manufacturing,” said Michael P. Garippa, SynCardia CEO and President.
“The other critical material needed to ensure uninterrupted manufacturing of the SynCardia Total Artificial Heart,” added Garippa, “was acquired in June 2011 when we purchased the formula, reactor and exact manufacturing equipment that have been used to make segmented polyurethane solution (SPUS). We are the only source for SPUS in the world.”
Fatigue resistance, strength and biocompatibility make SPUS ideally suited for the blood contacting and flexing components of the SynCardia Heart and other medical devices. For over thirty years it has been - used for the housings, diaphragms and connectors of the Total Artificial Heart.
SynCardia’s acquisition ensured the SynCardia Total Artificial Heart would continue to have the same material properties and manufacturing process it had historically.
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 1,350 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.