The SynCardia total artificial heart with SynHall valves has received CE mark approval. The CE mark gives SynCardia systems control over the last critical component for SynCardia heart manufacturing.
To ensure the quality and uninterrupted production of the SynCardia total artificial heart, the company now has control over the two critical components required for heart manufacturing: CE mark approval for the SynCardia total artificial heart with SynHall valves, and SynCardia which is the world’s only source for the unique formula of segmented polyurethane solution (SPUS).
SynCardia Systems 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, material 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,” says Michael P Garippa, SynCardia chief executive officer and president.