The company Carmat designer and developer of the artificial heart project announced in a statement that “the first implantation of its bioprosthetic artificial heart within the framework of the PIVOT study was carried out in accordance with the authorizations of the Committee for the Protection of Persons (CPP) and the National Medicines Safety Agency (ANSM). This is the second phase of this clinical trial. Thanks to this new installation, the company will be able to collect new clinical data and complete the technical data of the CE marking file in order, ultimately, to sell “the most advanced artificial heart in the world, aimed at offering an alternative to patients suffering from terminal biventricular heart failure ”. “In accordance with good clinical practice, the company recalls that it does not plan to communicate individually on the locations of the patients in the study and on their state of health,” the press release recalls.
A study carried out on 20 to 25 patients
This announcement follows a clinical trial conducted in France between September 2013 and January 2016. Four patients, now deceased, have undergone a Carmat heart implantation, but these operations had already demonstrated the performance of this new process. Indeed, the first patient survived 75 days (instead of 30 days advertised), the second nine months, the third eight months and the fourth died from medical complications. The prosthesis was not implicated in any of these deaths.
On July 13, 2016, the Carmat company received a favorable opinion from the CPP, as well as the authorization from the ANSM. “The authorization to start the PIVOT study is a major step taken by Carmat. It is part of the CE marking process that we have initiated. The results of studies in France and the rest of Europe will be integrated into the clinical module of the dossier, the assessment of which has been entrusted to DEKRA ”, concludes Marcello Conviti, CEO of Carmat. This study will be carried out on 20 to 25 patients followed for 180 days in ten implantation centers in Europe.
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