SynCardia (a subsidiary of Picard Medical) makes and sells the SynCardia Total Artificial Heart (TAH), a device that fully replaces both heart ventricles and all four valves in patients with end-stage biventricular heart failure. The SynCardia TAH is the only TAH approved for commercial use in the U.S. and Canada. The device is used primarily as a bridge to transplantation, keeping patients alive while they await a donor heart. It is available in two sizes: a 70cc model FDA-approved in 2004 for adults, and a 50cc model FDA-approved in 2020 for smaller adults and pediatric patients. The device is powered by external pneumatic drivers — a hospital-based C2 Driver and a portable Freedom Driver that allows patients to go home while awaiting transplant. SynCardia sells the TAH implant, drivers, and related components directly to hospitals, which are reimbursed by CMS and private insurers. SynCardia manufactures its products at its Tucson, Arizona facility using a proprietary polyurethane material it argues is difficult to replicate. SynCardia's growth strategy includes expanding its U.S. label to cover additional patient populations, re-entering the EU market after losing its CE Mark in 2022, pursuing regulatory approval in China, and developing next-generation products including the Emperor TAH — a fully implantable, driverless version of the device targeting FDA approval as early as 2028.