The approval allows the company to manufacture Total Artificial Heart with SynHall valves.
SynCardia already received the CE Mark for European use of the SynHall valves only in the SynCardia Total Artificial Heart on 17 April 2014.
On 28 July 2014, Health Canada has also approved Total Artificial Heart with SynHall valves.
The company noted that SynHall valves will be used only in the SynCardia Heart of the design, materials and nearly identical manufacturing processes as the tilting-disk valves, which have been used in the Total Artificial Heart.
The valves, which are made by using titanium and pyrolytic carbon, have been used in around 1300 implants of the SynCardia Total Artificial Heart.
SynCardia Systems CEO and president Michael Garippa said, "We’re delighted that the SynHall valves passed the FDA’s rigorous approval process."
In addition, the company manufactures segmented polyurethane solution (SPUS), which is used in the housings, diaphragms and connectors of SynCardia Total Artificial Heart.
SynCardia Total Artificial Heart will be used to transplant for people, who are suffering from end-stage biventricular heart failure in which both ventricles cannot pump enough blood for a person to survive to survive.
The company also manufactures Freedom portable driver, which helps clinically stable patients to leave the hospital and live at home and in their communities.
Image: SynCardia Systems has received FDA approval to manufacture SynCardia Total Artificial Heart with SynHall valves. Photo: courtesy of PR Newswire/ SynCardia Systems, Inc.
