Carmat, the designer and developer of the world’s most advanced total artificial heart, aims to address an unmet medical need by providing a therapeutic alternative to people with end-stage biventricular heart failure. The company has announced that it has obtained approval from the ANSM (French Agency for the Safety of Medicines and Health Products) and the CPP Ouest III (ethics committee) to carry out implants of its device within the framework of the PIVOTAL study in France.
These approvals open the possibility for French patients to receive the Carmat device and for French hospitals to contribute to the completion of recruitment in the PIVOTAL study by the end of the first quarter of 2021.
To date, the number of implants performed as part of the PIVOTAL study is 13, including 10 in the first cohort, now closed, and three in the second cohort, which is currently recruiting patients.
Stéphane Piat, CEO of Carmat, declared: “We are delighted to be able to take back Carmat heart implants in France. The rate of registrations, impacted by the COVID-19 situation … could therefore accelerate with the participation of highly specialized French people We are working simultaneously with centers in the United States to allow the American feasibility study (EFS) to begin before the end of the year, as planned ”.
Professor Jean-François Obadia, head of the cardiothoracic surgery and heart transplantation service at Louis Pradel Hospital (CHU LYON) and national principal investigator of the study, added: “Our participation in the PIVOTAL study will finally give us access to this innovative technology which responds to an urgent clinical need, for which until now we had no satisfactory solution. The performance of prostheses observed in the first patients already implanted abroad and our recent experience during the training of our teams in France are very encouraging. We are delighted to have this opportunity. “