Michael Barbella, Managing Editor12.09.22
CARMAT can restart its Aeson study in France.
The company 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 of Aeson, an artificial heart designed to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure. 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.
“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," CARMAT CEO Stéphane Piat said. "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.”
Four centers have undergone refresher trainings on the product and clinical protocol ahead of the restart and are ready to screen patients (APHP-HU Pitié Salpêtrière, CHRU Lille, CHU Rennes and CHU Strasbourg). Approximately €13 million in funding from the French National Innovation Fund is partially financing this study.
The approval to restart clinical trials follows DEKRA approval to resume commercial implants as well. After reviewing CARMAT filings, DEKRA provided notified body approval of all changes implemented by the company in response to the quality issues that led it to voluntarily and temporarily suspend all Aeson implants late last year. The approval allows CARMAT to resume Aeson implants within the European Union and other countries that recognize CE marking. CARMAT confirms its intention to resume implants in Europe in the near future, at a gradual pace in line with the rebuilding of its prostheses inventory.
Aeson is designed to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure. Highly hemocompatible, pulsatile and self-regulated, Aeson could save, the lives of thousands of patients annually waiting for a heart transplant. The device features an ergonomic and portable external power supply system that is continuously connected to the implanted prosthesis. Aeson is commercially available as a bridge to transplant in the European Union and other countries that recognize CE marking. Aeson is also currently being assessed within the framework of an Early Feasibility Study (EFS) in the United States.
CARMAT designs, manufactures, and markets the Aeson artificial heart. Founded in 2008, CARMAT is based in the Paris region, with its head offices located in Vélizy-Villacoublay and its production site in Bois-d’Arcy. The company employs more than 200 workers and is listed on the Euronext Growth market in Paris.
The company 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 of Aeson, an artificial heart designed to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure. 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.
“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," CARMAT CEO Stéphane Piat said. "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.”
Four centers have undergone refresher trainings on the product and clinical protocol ahead of the restart and are ready to screen patients (APHP-HU Pitié Salpêtrière, CHRU Lille, CHU Rennes and CHU Strasbourg). Approximately €13 million in funding from the French National Innovation Fund is partially financing this study.
The approval to restart clinical trials follows DEKRA approval to resume commercial implants as well. After reviewing CARMAT filings, DEKRA provided notified body approval of all changes implemented by the company in response to the quality issues that led it to voluntarily and temporarily suspend all Aeson implants late last year. The approval allows CARMAT to resume Aeson implants within the European Union and other countries that recognize CE marking. CARMAT confirms its intention to resume implants in Europe in the near future, at a gradual pace in line with the rebuilding of its prostheses inventory.
Aeson is designed to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure. Highly hemocompatible, pulsatile and self-regulated, Aeson could save, the lives of thousands of patients annually waiting for a heart transplant. The device features an ergonomic and portable external power supply system that is continuously connected to the implanted prosthesis. Aeson is commercially available as a bridge to transplant in the European Union and other countries that recognize CE marking. Aeson is also currently being assessed within the framework of an Early Feasibility Study (EFS) in the United States.
CARMAT designs, manufactures, and markets the Aeson artificial heart. Founded in 2008, CARMAT is based in the Paris region, with its head offices located in Vélizy-Villacoublay and its production site in Bois-d’Arcy. The company employs more than 200 workers and is listed on the Euronext Growth market in Paris.
