SynCardia Systems

SynCardia Systems, LLC operates as a key player in the cardiac medical device industry, holding the distinction of manufacturing the world's only commercially approved Total Artificial Heart (TAH). Founded in 2001, the Tucson-based company emerged from the combined expertise of cardiothoracic surgeon Dr. Jack G. Copeland, biomedical engineer Richard G. Smith, and interventional cardiologist Dr. Marvin J. Slepian. Their collective vision was to salvage and advance the artificial heart technology, which traces its lineage back to the Jarvik-7, to address the critical gap between end-stage biventricular heart failure and the limited availability of donor hearts.

The company's business revolves around providing a life-saving solution for patients at risk of imminent death from irreversible biventricular failure. Its primary clients are highly specialized transplant hospitals and heart failure programs. The business model involves the sale of its sophisticated medical devices and the necessary support systems to these certified centers. A significant milestone was the initial FDA approval on October 15, 2004, which designated the TAH as a bridge to transplant for eligible patients. This was followed by approvals for a smaller 50cc version to accommodate more women and adolescents, and for the Freedom® portable driver, which allows clinically stable patients to live at home while awaiting a transplant.

SynCardia's core product is the temporary Total Artificial Heart (TAH-t), a pneumatically driven device that completely replaces the patient's failing native ventricles and four heart valves. It is available in two sizes, 70cc and 50cc, to fit a broader range of patients. The system functions with an external driver; the hospital-based Companion 2 (C2) driver provides pneumatic power from implant through recovery, while the lighter, portable Freedom® driver grants mobility to discharged patients. This ability for patients to leave the hospital significantly improves their quality of life. With a history of over 2,000 implants across more than 25 countries, the SynCardia TAH is the most widely used and studied device of its kind. After a period of Chapter 11 bankruptcy in 2016 and an acquisition by Versa Capital Management, SynCardia was acquired by Picard Medical, Inc. in September 2021, securing resources to pursue further innovation and market expansion.

Keywords: Total Artificial Heart, biventricular heart failure, bridge to transplant, cardiac medical devices, mechanical circulatory support, heart replacement technology, SynCardia TAH, Freedom portable driver, Picard Medical, Jack G. Copeland, Marvin J. Slepian, Richard G. Smith, end-stage heart failure, cardiothoracic surgery, artificial organs, heart transplant alternative, destination therapy, FDA approved medical device, implantable cardiac device, cardiovascular technology