CARMAT’s Aeson® artificial heart has seen increased adoption as a European bridge-to-transplant solution. By the end of October 2024, 30 patients successfully received heart transplants after being supported by the device. This highlights Aeson®’s ability to provide tailored physiological support, optimizing patients’ physical condition for transplant. Sixteen transplants, performed across seven countries, occurred in 2024, indicating a significant acceleration in Aeson®’s European adoption. Patients used the device for an average of 156 days, with a maximum recorded duration of 308 days. Aeson®’s CE marking allows its marketing in Europe and other regions to recognize the certification. It’s indicated explicitly as a bridge to transplant for patients with end-stage biventricular heart failure (Intermacs classes 1-4) who haven’t benefited from optimal medical therapy or a left ventricular assist device (LVAD) and are expected to receive a transplant within 180 days of implantation.
In late November 2024, CARMAT will host its first Aeson® European User Meeting. Over 100 European cardiology leaders will gather to share their experiences with the device. The meeting will feature case studies and feedback from various healthcare professionals involved in patient management, including cardiologists, surgeons, anesthetists, and intensive care specialists. The aim is to improve patient identification for Aeson® and enhance center expertise. This event is a key step towards wider device adoption and improved management of advanced biventricular heart failure. Throughout 2024, CARMAT has intensified its information and training efforts, participating in approximately ten key conferences with hundreds of attendees. This underscores the growing professional interest in Aeson® and the urgent need for effective treatments for patients often facing limited therapeutic options.
While the bridge-to-transplant indication shows promise, CARMAT aims to secure the ‘destination therapy’ (‘DT’) indication. This would allow patients to live long-term with Aeson® support, eliminating the need for a subsequent transplant. CARMAT plans to restart its PIVOTAL study in Europe during the second half of 2025, focusing on patients ineligible for transplant. DT approval would significantly address the critical organ shortage, as currently, only 5% of patients needing a transplant receive one. The DT indication represents a substantial market opportunity in cardiology, though achieving this may take several years.
The increasing success of Aeson® as a bridge to transplant demonstrates its potential to improve outcomes for advanced heart failure patients. The device’s growing adoption and positive impact on patient preparedness for transplantation positions it as a potential first-line treatment for end-stage heart failure. The upcoming user meeting and increased engagement with the medical community further solidify Aeson®’s potential as a standard of care in advanced biventricular heart failure treatment.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
