SynCardia Systems, Inc. tells us it has received U.S. FDA approval for its SynCardia temporary Total Artificial Heart with SynHall valves, giving the company control over the last key component to manufacture the Total Artificial Heart.
Originally used as a permanent replacement heart, the SynCardia Total Artificial Heart is currently approved as a bridge to transplant for people suffering from end-stage biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive.
The company has received FDA approval to manufacture the SynHall valves used only in the SynCardia Total Artificial Heart. This gives it control over two critical components for heart manufacturing: The valves and the unique formula for segmented polyurethane solution (SPUS), which is manufactured only by SynCardia.
FDA approval follows SynCardia’s receipt of the CE Mark for European use of the SynHall valves only in the SynCardia Total Artificial Heart on April 17, 2014. Health Canada approval was received for the same purpose on July 28, 2014.
The SynHall valves only for use in the SynCardia Heart are of 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 of titanium and pyrolytic carbon, these robust 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.
“We’re delighted that the SynHall valves passed the FDA’s rigorous approval process,” says Michael P. Garippa, SynCardia CEO and President.
Source: SynCardia, Inc., PR Newswire