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 /PRNewswire/ -- 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.
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About the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. (Tucson, AZ) is the privately-held 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 heart failure affecting both sides of the heart (biventricular failure).
There have been more than 1,300 implants of the Total Artificial Heart, accounting for almost 400 patient years of life on the device. The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 76 years old.
Similar to a heart transplant, the SynCardia Total Artificial Heart replaces both failing heart ventricles and the four heart valves. It is the only device that eliminates the symptoms and source of end stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at 97 SynCardia Certified Centers worldwide with 39 others in the process of certification.
The Total Artificial Heart provides immediate, safe blood flow of up to 9.5 liters per minute through each ventricle. This high volume of blood flow helps speed the recovery of vital organs, helping make patients better transplant candidates.
SOURCE SynCardia Systems, Inc.