Carmat - First half of CE mark-enabling trial fully enrolled

In July, Carmat announced the enrolment of the 10th and final patient included in the first leg of its EU pivotal study investigating the surgical implantation of the Carmat total artificial heart (TAH) in patients suffering from end-stage biventricular heart failure (HF). Following the successful surgeries, the company expects to enrol an additional 10 patients in the second cohort by the year end. According to Carmat, data from all 20 patients should be sufficient to obtain CE marking for the bioprosthesis in 2019. Most notably, Carmat announced the first successful donor heart transplant of a TAH patient who was initially too sick to receive a donor heart.