Carmat, developer of the Aeson total artificial heart, has announced that it has been granted the necessary regulatory approvals from the French National Agency for Medicine and Health Product Safety (ANSM) and the Patient Protection Committee (CPP Ile-de-France XI) to restart the EFICAS Clinical Study.
The study will include 52 transplant-eligible patients 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.
Ahead of the restart, four centres have undergone refresher trainings on the product and clinical protocol and are ready to screen patients—APHP-HU Pitié Salpêtrière, CHRU Lille, CHU Rennes and CHU Strasbourg.
The company has also announced that it has been granted the necessary regulatory approvals to resume implants in a commercial setting. Coupled with the clinical study approval, Carmat has confirmed its intention to resume implants in Europe in the near future, at a gradual pace in line with the rebuilding of its prostheses inventory.
Stéphane Piat, chief executive officer of CARMAT, said: “This approval is very positive news for French patients who will now be able to benefit from Aeson as part of the EFICAS study that we will shortly be initiating in France. This study is also instrumental for the company as it will allow us to collect essential medico-economic data to support the reimbursement of our therapy, notably in France. Our teams are working hard to build prostheses inventory to support the resumption of our implants in Europe.”