SynCardia Systems' temporary total artificial heart with SynHall valves has received CE Mark approval, the last critical component needed for manufacturing the device.
The SynHall valves for use only as part of the SynCardia total artificial heart feature the same design, materials and nearly identical manufacturing processes as the tilting-disk valves that have always been used in the total artificial heart, according to the company.
These valves, which are made up of titanium and pyrolytic carbon, have never failed in more than 1,300 implants of the SynCardia total artificial heart, accounting for more than 5,000 valves and at least 30 years of use.
SynCardia president and CEO Michael Garippa said that with the CE Mark for SynCardia total artificial heart with SynHall valves, the company controls the last of two key components required for SynCardia Heart manufacturing.
"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)," Garippa said.
With fatigue-resistance, strength and biocompatibility, the segmented polyurethane solution is well-suited for the blood contacting and flexing components of the SynCardia heart and other medical devices.
SynCardia has filed applications with the US Food and Drug Administration (FDA) and Health Canada for similar approvals for the SynCardia total artificial heart with SynHall valves. The company anticipates approvals in later 2014.
The company previously received the FDA and CE Mark approvals for the SynCardia heart. The device has been originally used as a permanent replacement heart.
Currently, the total artificial heart is approved as a bridge to transplant for people suffering from end-stage heart failure affecting both sides of the vital organ.
The SynCardia total artificial heart replaces both failing ventricles and the four valves, and eliminates the symptoms and source of end-stage biventricular failure.
The artificial heart provides immediate, safe blood flow of up to 9.5l per minute through each ventricle. This high-volume of blood flow enables the quick recovery of vital organs, helping make patients better transplant candidates.
SynCardia Systems's total artificial heart is immediately available at 97 certified centres worldwide, with 39 others in the process of certification.
Image: SynCardia total artificial heart with SynHall valves receives CE Mark. Photo: courtesy of SynCardia Systems, Inc.