SynCardia Systems Inc. received the CE Mark with SynHall valves for the SynCardia temporary Total Artificial Heart, providing the company with control over the last key component which was required for heart manufacturing.

The SynHall valves are only used for SynCardia Total Artificial Heart. These valves has nearly identical manufacturing processes as well as the same design and materials as the tilting-disk valves which have always been used in the Total Artificial Heart.

SynCardia has made applications for similar approvals to Health Canada regulatory bodies and FDA. Approvals by both the regulatory bodies for the SynCardia Total Artificial Heart with the SynHall valves are hopefully expected for later this year.

These robust valves of pyrolytic carbon and titanium have never failed in more than 1,300 implants of the SynCardia Heart, accounting for well over 30 years of use and over 5, 000 valves.

According to SynCardia President and CEO, Michael P. Garippa, with the CE Mark for SynCardia Total Artificial Heart with SynHall valves, they control the last of two key components required for SynCardia Heart manufacturing.

Garippa added that the other critical material needed to ensure uninterrupted manufacturing of the SynCardia Total Artificial Heart was purchased in June 2011 when they brought the reactor, formula and exact manufacturing equipment which have been used to make SPUS (segmented polyurethane solution). SynCardia is the only source for SPUS in the world.

Strength, fatigue resistance and biocompatibility make SPUS ideally suited for the flexing and blood contacting elements of the SynCardia Heart and other medical devices. For over thirty years SPUS has been used for the connectors, housings and diaphragms of the Total Artificial Heart.

SynCardia’s acquisition has ensured that the SynCardia Total Artificial Heart would continue to have the same manufacturing process and material properties that it had historically.