PARIS– CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today announces that it has received final approval from the Patient Protection Committee (CPP Ile-de-France XI) for the use of the commercial version of the Aeson® heart in the EFICAS study in France.
This agreement from the CPP Ile-de-France XI applies to the dossier submitted by CARMAT in the first half of 2021 and enables it to use the latest version of its Aeson® artificial heart in the EFICAS study.
This agreement paves the way for the start of this study, with recruitment expected to begin in the fourth quarter of 2021 in the first six centers that have expressed an interest in taking part in the trial (APHP Hôpital européen Georges-Pompidou, APHP-HU Pitié Salpêtrière, CHRU Lille, CHU Lyon, CHU Rennes and CHU Strasbourg).
As a reminder, CARMAT had already obtained the approvals of the French National Agency for Medicine and Health Product Safety (ANSM) and the French National Authority for Health (HAS) on the clinical protocol of this study, and benefits from €13 million in funding from the National Innovation Fund, granted by the French Ministry of Solidarity and Health, to partially finance it.
The study will cover 52 implants in France and will allow CARMAT to collect both additional data on the efficacy and safety of its artificial heart, and medico-economic data to support the value proposition and reimbursement of the device, notably in France.
Stéphane Piat, Chief Executive Officer of CARMAT, stated: “I am pleased that the patient protection committee has agreed to the use of the most recent version of Aeson® in the EFICAS study. This medico-economic study is of major interest for our development in France as the data collected will in particular support our reimbursement application for Aeson® in our domestic market. I am also delighted that 6 of the most prestigious French cardiology hospitals have placed their trust in us and will allow French patients to benefit from our unique therapy.”
