Carmat’s Aeson Total Artificial Heart Implanted in Second Patient in Early Feasibility Study

August 25, 2021—Carmat, SA, the France-based designer and developer of the Aeson total artificial heart, announced that the second center in the United States has implanted the prosthetic heart within the framework of the early feasibility study (EFS).

With the Aeson bioprosthetic artificial heart, the company aims to provide a therapeutic alternative to patients with end-stage biventricular heart failure.

On July 15, Carmat announced that the first human implant of the Aeson heart in the United States conducted within the EFS was performed by Jacob N. Schroder, MD, and Carmelo A. Milano, MD, at Duke University Hospital in Durham, North Carolina. Dr. Milano serves as a Principal Investigator of the EFS.

The second implant procedure was performed at Jewish Hospital in Louisville, Kentucky, by a team led by Principal Investigator Mark S. Slaughter, MD, who is Professor and Chair of the Department of Cardiovascular and Thoracic Surgery at the University of Louisville (UofL) and UofL Physicians.

“We are pleased to be part of the first United States centers to investigate this new artificial heart technology,” commented Dr. Slaughter in Carmat’s press release. “This clinical study will help us determine whether the device’s distinguishing features such as hemocompatibility and blood flow autoregulation are beneficial to critically ill patients suffering from biventricular heart failure who currently have very limited treatment options.”

According to the company, three additional centers in the United States are fully trained and are currently screening patients for the study.

The study protocol approved by the FDA calls for 10 transplant-eligible patients 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, advised Carmat.