SynCardia (Tucson, AZ) won FDA approval for its SynCardia Total Artificial Heart with SynHall valves, the last of the approvals necessary to manufacture the hearts for sale in the U.S. The device has recently been approved in Canada and Europe.
The SynHall valves, made of titanium and pyrolytic carbon, are nearly identical to the tilting-disk valves used with the Total Artificial Heart in the past. The company touts that after more than 1,300 artificial heart implants that involved more than 5,000 of the valves, not one failure has been reported.
Flashbacks: SynCardia Freedom Driver FDA Approved to Discharge Patients with Total Artificial Heart…; SynCardia Total Artificial Heart Receives FDA Humanitarian Use Device Designation for Destination Therapy…; SynCardia 50cc Total Artificial Heart Wins FDA HUD Designations for Children and Small Adults…;
Press release: FDA Approves the SynCardia Total Artificial Heart With SynHall Valves…