US-based SynCardia Systems has obtained CE Mark approval for its SynCardia temporary total artificial heart with SynHall valves.
SynCardia Systems had obtained the CE Mark approval in April 2014 and this approval provides the company with control over the last key component required for heart manufacturing.
According to the company, 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.
Made up of titanium and pyrolytic carbon, these valves have never failed in more than 1,300 implants of the SynCardia total artificial heart, accounting for well over 5,000 valves and over 30 years of use.
SynCardia CEO and president 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). We are the only source for SPUS in the world," Garippa added.
According to SynCardia, segmented polyurethane solution has fatigue resistance, strength and biocompatibility. These fatures make it well suited for the blood contacting and flexing components of the SynCardia heart and other medical devices.
SPUS has been used for over 30 years for the housings, diaphragms and connectors of the total artificial heart.
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.
SynCardia Systems had already received the FDA and CE Mark approvals for the SynCardia heart. The device has been originally used as a permanent replacement heart.
The total artificial heart is currently approved as a bridge to transplant for people suffering from end stage heart failure affecting both sides of the heart (biventricular failure).
The SynCardia total artificial heart replaces both failing heart ventricles and the four heart valves, and eliminates the symptoms and source of end stage biventricular failure. It provides immediate, safe blood flow of up to 9.5l per minute through each ventricle.
This high volume of blood flow helps speed the recovery of vital organs, helping make patients better transplant candidates.
According to SynCardia Systems, the total artificial heart is immediately available at 97 SynCardia Certified Centers across the globe with 39 others in the process of certification.
Image: SynCardia Systems’ SynCardia total artificial heart with SynHall valves. Photo: Courtesy of SynCardia Systems, Inc.