Picard Medical Inc 's

The total artificial heart (TAH) market includes alternative mechanical circulatory support devices such as left ventricular assist devices (LVAD), extracorporeal membrane oxygenation (ECMO) systems, and percutaneous axial flow ventricular assist devices like the Impella system. The SynCardia Total Artificial Heart is the only TAH approved for commercial use in the United States and Canada. Carmat SA has developed the Aeson total artificial heart, which holds CE mark approval in Europe; however, as of 2025, Carmat SA is undergoing financial distress and insolvency proceedings, placing its manufacturing and commercial operations at risk. The SynCardia TAH is available in two sizes (50cc and 70cc) and has been implanted in over 2,100 patients worldwide, with more than 30 years of clinical use. The competitive landscape continues to evolve, with several programs in clinical development or early commercialization stages. Regulatory approvals, clinical outcomes, physician adoption, and long-term device performance are key factors influencing competition in this sector.