Carmat obtains ANSM approval to resume PIVOTAL study implants in France

Carmat, the designer and developer of the world's most advanced total artificial heart, is aiming to fulfil an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure. The company has  announced that it has obtained ANSM (French agency for the safety of medicines and health products) and CPP Ouest III (ethics committee) approval to perform implants of its device within the framework of the PIVOTAL study in France.

These approvals open up the possibility for French patients to receive the Carmat device and for French hospitals to contribute to the completion of enrolment in the PIVOTAL study by the end of Q1 2021.

To date, the number of implants performed within the framework of the PIVOTAL study stands at 13, including 10 in the first cohort, now closed, and three in the second cohort, which is currently enrolling patients.

Stéphane Piat, Chief Executive Officer of Carmat, said: "We are delighted to be able to resume implants of the Carmat heart in France. The enrolment pace, impacted by the COVID-19 situation … could hence accelerate with the participation of highly specialized French centers to complete this key study. We are simultaneously working with centers in the United States to enable the US early feasibility study (EFS) to begin before the end of the year, as planned".

Professor Jean-François Obadia, Head of the Cardiothoracic Surgery and Heart Transplant department at Louis Pradel hospital (CHU LYON) and the study's national Principal Investigator, added: "Our participation in the PIVOTAL study will finally give us access to this innovative technology that meets an urgent clinical need, for which we so far had no satisfactory solution. The prosthesis' performances 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."