Carmat Resumes Commercial Implantations of Aeson Artificial Heart in Europe

November 21, 2022—Carmat, the France-based designer and developer of a total artificial heart for patients with end-stage biventricular heart failure as an alternative to heart transplantation, announced that the resumption of commercial implantations of its Aeson artificial heart is now effective.

According to the company, the Aeson artificial heart is highly hemocompatible, pulsatile, and self-regulated. Aeson is commercially available as a bridge to transplantation in the European Union and other countries that recognize CE Mark.

On October 25, Carmat announced that the Dekra notified body had approved all the changes implemented on Aeson, thus allowing the company to resume commercial implantations in countries that recognize CE Mark. Subsequently, a commercial implantation of Aeson was recently performed in a hospital in Germany.

The company advised that implantations will continue to resume at a gradual pace in line with the rebuilding of its inventory of implantable prostheses.

Carmat further stated that in accordance with the principles it has consistently applied, it does not plan to communicate on the state of health of individual patients or the performance of each implantation. The company will continue to communicate on its progress when it reaches significant milestones and when it publishes its financial results.

Stéphane Piat, CEO of Carmat, commented in the company’s press release, “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. 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.”

Additionally, Aeson is currently being assessed within the framework of an early feasibility study in the United States. The company announced the first implantation in the study in July 2021 and announced the second implantation in August 2021.