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The SynCardia Total Artificial Heart has been implanted in over 2,000 patients worldwide across more than 20 countries. It remains the only FDA-, Health Canada-, and CE-approved total artificial heart as a bridge to transplantation. Clinical data demonstrate its ability to provide life-saving circulatory support for patients with end-stage biventricular failure who are awaiting donor hearts. The device has also been used as destination therapy when transplantation was not possible; one patient survived over six years on the system at home.
The company continues R&D on next-generation fully implantable artificial hearts ("SynCardia Emperor") and portable drivers.
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