Carmat’s Aeson Total Artificial Heart Implanted in the United States

July 15, 2021—Carmat, SA, announced the first human implant of its Aeson bioprosthetic artificial heart in the United States within the framework of the early feasibility study (EFS). The company has designed and developed the total artificial heart as a therapeutic alternative for patients with end-stage biventricular heart failure.

Jacob N. Schroder, MD, and Carmelo A. Milano, MD, heart surgeons at Duke University Hospital in Durham, North Carolina, led the team that performed the first implant procedure. Dr. Milano serves as Principal Investigator of the EFS.

Three additional centers in the United States are fully trained and are currently screening patients for the study, advised Carmat.

The company stated that in accordance with the study protocol approved by the FDA, 10 transplant-eligible patients are expected to be enrolled in this trial. The primary study endpoint is patient survival at 180 days postimplant or a successful cardiac transplantation within 180 days postimplant. It is a staged study with a progress report of the first three patients after 60 days, before the enrollment of the next seven patients.

“We are pleased to be the first United States center to investigate a new therapeutic alternative for critically ill patients suffering from end-stage biventricular heart failure,” commented Dr. Milano in Carmat’s press release. “This clinical study will help us determine whether the device’s properties—including hemocompatibility, pulsatility, autoregulation, and silent operation—are beneficial to patients who currently have very few options.”

The Aeson total artificial heart is composed of the implantable bioprosthesis and a portable external power supply system, to which it is continuously connected.

According to the company, Aeson is the first physiologic heart replacement therapy. Assuming successful clinical development, the Aeson—with highly biocompatible materials, a self-regulation system, and pulsatile nature—potentially could save the lives of thousands of patients each year with no risk of rejection and with an enhanced quality of life.

Carmat’s development of Aeson combined the medical expertise of Professor Alain Carpentier, MD—inventor of the Carpentier-Edwards heart valves (Edwards Lifesciences)—with the technological expertise of Airbus Group, the French aerospace company. Carmat was cofounded by Prof. Carpentier, Matra Défense SAS (a subsidiary of the Airbus Group), the Centre Chirurgical Marie Lannelongue in Le Plessis-Robinson, France, and Truffle Capital with other investors. Stéphane Pia is Chief Executive Officer of Carmat.