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. 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.
For more: SynCardia Total Artificial Heart with SynHall Valves Receives CE Mark
