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.Carmat is focused on the research and development of an innovative product in the medical sector, developing an orthotopic and biocompatible artificial heart which is completely implantable, as well as its electrical power supply system and remote diagnosis system. Co. is developing a long-term therapeutic solution for patients who suffer from advanced bi-ventricular heart failure and who are not eligible for cardiac transplantation and who have exhausted all drug possibilties. Co. is still in the phase of research and development and thus do not generate any revenues.
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