CARMAT Given Approval to Resume Artificial Heart Implants

Testing, Inspection, and Certification expert organization DEKRA has granted CARMAT approval to resume commercial implants of its advanced total artificial heart, Aeson. 

After reviewing CARMAT filings, DEKRA has 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.

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 intends to gradually resume European sales of Aeson in order to rebuild its prostheses inventory.

“DEKRA’s approval allows us to resume Aeson implants within a commercial setting in Europe, which is excellent news both for patients and for our company. We will be resuming implants very soon and moving forward at a measured pace as we continue building our inventory of implantable prostheses, and ensure all patients are suitably monitored,” CARMAT CEO Stéphane Piat said. “We are also making good progress on plans to resume clinical trials and we will be providing additional updates on this in due course.”  

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. CARMAT is listed on the Euronext Growth market in Paris.