In July, Carmat (PA:ALCAR) 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.
Completes enrolment of first leg of pivotal trial
Carmat announced the completion of enrolment of the first portion of its EU pivotal study investigating the safety and efficacy of the surgical implantation of the Carmat TAH as an alternative therapeutic among those waiting for human transplants and/or suffering from terminal HF and potentially terminal acute myocardial infarctions (MI). The primary endpoint of the trial is overall survival at six months post-implant, or overall survival to human cardiac transplantation.
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