Carmat SA announced an update on its clinical progress and recent developments. The interim analysis concerned the 10 patients of the first cohort of the PIVOTAL study, the first of whom was enrolled in August 2016 and the last in July 2018. Altogether, the study foresees the enrollment of 20 patients suffering from end-stage biventricular heart failure. 70% of the patients in this first cohort reached the study’s primary endpoint, corresponding to six-month survival with the bioprosthesis or a successful heart transplant within 6 months after device implant. By comparison, this rate was only of 50% for the feasibility study and 54-62% for the only total artificial heart currently on the market1. The data collected from the patients having achieved the study’s primary endpoint again confirm the biocompatibility of the CARMAT prosthesis, already proved during the feasibility study, and notably its positive safety profile, never before achieved by other technologies, with the absence of cerebrovascular accidents, gastrointestinal bleeding or infections due to the percutaneous cable. Furthermore, these patients only required light anticoagulant therapy. Patient enrollment for the second part of the PIVOTAL study began in accordance with the protocol in September 2018 in international medical centers. To date, the cumulative support time of the CARMAT heart within the framework of the PIVOTAL study has reached 5 years in the 11 implanted patients. This accumulated experience shows the ability of the CARMAT technology to provide a long-term solution for patients suffering from end-stage biventricular heart failure, along with a substantial improvement in their quality of life. The analysis of the collected data, representing over 20 years of cumulative operating between the clinical study and the reliability tests benches, has made it possible to identify aspects in which the manufacturing process could be improved, essentially concerning the control of the integrity of the prosthesis and the cleanliness of its technical compartment. Since the submission of an Investigational Device Exemption (IDE) application for an Early Feasibility Study (EFS) in 2018, CARMAT has been holding constructive talks with the FDA.