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.
About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the SynCardia Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.
Janelle Drumwright, email@example.com, (520) 547-7463