Tucson, Ariz. – 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 more than 5,000 valves and more than 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.