SynCardia’s SynHall Valves Receives CE Mark

Syncardia Systems Inc. has received the CE Mark approval for the SynCardia temporary Total Artificial Heart with SynHall valves, providing the Tuscon, Ariz.-based 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 the U.S. Food and Drug Administration and Health Canada; approval of the SynCardia Total Artificial Heart with the SynHall valves could come later this year.

The valves of titanium and pyrolytic carbon have not 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, the company contends.

“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 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 more than 30 years it has been used for the housings, diaphragms and connectors of the Total Artificial Heart.

SynCardia Systems is a privately-held manufacturer of the Total Artificial Heart. Originally used as a permanent replacement heart, the SynCardia Total Artificial Heat currently is 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 1,260 implants of the Total Artificial Heart, accounting for more than 350 patient years of life on the device.

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 the patient a better transplant candidate, the company claims.