Michael Barbella, Managing Editor02.02.23
CARMAT is once again implanting its Aeson artificial heart in patients, after voluntarily and temporarily suspending such procedures in late 2021.
After reviewing CARMAT filings, the DEKRA notified body approved all changes implemented by the company in response to the quality issues that led it to voluntarily and temporarily suspend all Aeson implants. The approval allowed CARMAT to resume Aeson implants within the European Union and other countries that recognize CE marking.
In view of this, the company implanted Aeson in a patient at a German hospital. Implants will continue to resume at a gradual pace in line as CARMAT rebuilds its implantable prostheses inventory.
“The resumption of implants was eagerly awaited by many physicians, and we are delighted that European patients are able to benefit from our therapy again," CARMAT CEO Stéphane Piat said. "In accordance with our roadmap, we continue to rebuild our inventory of prostheses, paying particular attention to quality control, in order to be in a position to gradually meet demand from medical centers, both in a commercial setting and within the framework of our clinical trials.”
CARMAT is a French medtech firm that designs, manufactures, and markets the Aeson artificial heart. The company’s ambition is to make Aeson the first alternative to a heart transplant, and thus provide a therapeutic solution to people suffering from end-stage biventricular heart failure, who are facing a well-known shortfall in available human grafts. The world’s first physiological artificial heart that is highly hemocompatible, pulsatile and self-regulated, Aeson could save the lives of thousands of patients waiting for a heart transplant. The device offers patients quality of life and mobility thanks to its 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.
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 a multidisciplinary team of more than 200 workers. CARMAT is listed on the Euronext Growth market in Paris.
After reviewing CARMAT filings, the DEKRA notified body approved all changes implemented by the company in response to the quality issues that led it to voluntarily and temporarily suspend all Aeson implants. The approval allowed CARMAT to resume Aeson implants within the European Union and other countries that recognize CE marking.
In view of this, the company implanted Aeson in a patient at a German hospital. Implants will continue to resume at a gradual pace in line as CARMAT rebuilds its implantable prostheses inventory.
“The resumption of implants was eagerly awaited by many physicians, and we are delighted that European patients are able to benefit from our therapy again," CARMAT CEO Stéphane Piat said. "In accordance with our roadmap, we continue to rebuild our inventory of prostheses, paying particular attention to quality control, in order to be in a position to gradually meet demand from medical centers, both in a commercial setting and within the framework of our clinical trials.”
CARMAT is a French medtech firm that designs, manufactures, and markets the Aeson artificial heart. The company’s ambition is to make Aeson the first alternative to a heart transplant, and thus provide a therapeutic solution to people suffering from end-stage biventricular heart failure, who are facing a well-known shortfall in available human grafts. The world’s first physiological artificial heart that is highly hemocompatible, pulsatile and self-regulated, Aeson could save the lives of thousands of patients waiting for a heart transplant. The device offers patients quality of life and mobility thanks to its 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.
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 a multidisciplinary team of more than 200 workers. CARMAT is listed on the Euronext Growth market in Paris.