January 4th 2023
CARMAT (FR0010907956, ALCAR), designer and developer of Aeson®, the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announced the first implantation of its Aeson® artificial heart within the framework of the EFICAS clinical study in France.
On October 26, 2022, CARMAT announced that it had received the necessary regulatory approvals to resume the EFICAS clinical study.
The first Aeson® implantation within the framework of this study was performed during the last week of December 2022 by Prof. André Vincentelli and his team at Lille Regional University Hospital.
In addition to the Lille hospital, five other medical centers take part in this study: Pitié Salpêtrière University Hospital and Georges Pompidou European Hospital in Paris, Rennes University Hospital, Strasbourg University Hospital and Lyon University Hospital (Hospices Civils de Lyon).
This prospective study will involve a total of 52 patients eligible for a heart transplant 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 its value proposition and the device’s reimbursement, notably in France. The study’s primary endpoint is survival for 180 days after implantation of the device without a disabling stroke, or a successful heart transplant within 180 days of implantation.
CARMAT benefits from 13 million euros in funding from the French National Innovation Fund to partially finance this study.
In accordance with the principles it has consistently applied, the Company does not plan to communicate on the state of health of individual patients nor on the performance of each implantation. CARMAT will continue to communicate on its progress when it reaches significant milestones and when it publishes its financial results.