SynCardia Systems has announced that it received approval on 2 July, 2104 from the United States Food and Drug Administration (FDA) for the SynCardia temporary Total Artificial Heart with SynHall valves, giving the company control over the last key component to manufacture the Total Artificial Heart.
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 17 April, 2014. Health Canada approval was received for the same purpose on 28 July, 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.
According to SynCardia, these valves, made of titanium and pyrolytic carbon, 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.