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Jump to Key Points MUNICH — Nine months after its takeover by industrialist Pierre Bastid and following bankruptcy proceedings earlier this year, the French medical device company CARMAT may finally have some good news.
Results from the EFICAS study evaluating the clinical performance of the fully implantable Aeson total artificial heart (TAH) were presented at the European Society of Cardiology (ESC) Congress 2026 by André Vincentelli, MD, PhD, of Lille University Hospital and the Lille Heart and Lung Institute in Lille, France, and were published simultaneously in the European Heart Journal.
“The results obtained with the Aeson® TAH in the EFICAS study provide the medical community, for the first time, with robust and objective clinical data on its performance,” Vincentelli said in a company press release.
Study Details
- EFICAS: 55 advanced HF pts; median age 56; 49% INTERMACS 1-2.
- 36% on VA-ECMO at Aeson implantation.
- 180-day composite endpoint met in 72.7% vs 38% historical threshold.
- 180 days: 96% stroke-free; 76% discharged; median LOS 54 days.
- Functional status improved: 6MWT +305 m; EQ-5D +40 points; no hemolysis.
EFICAS is a prospective, multicenter study conducted at 10 French hospitals. The analysis presented at ESC included 55 patients who received the device between December 2022 and May 2025, making it the largest clinical study of the Aeson device to date.
The median patient age was 56 years. Nearly half of the cohort (49%) had INTERMACS profile 1 or 2, a classification used to describe the severity of advanced heart failure in candidates for mechanical circulatory support. Profile 1 corresponds to critical cardiogenic shock, while profile 2 indicates progressive clinical deterioration despite ongoing therapy. In addition, 36% of patients were receiving venoarterial extracorporeal membrane oxygenation, a form of temporary mechanical circulatory support, at the time of implantation.
The study’s composite primary endpoint was 180-day survival, defined as survival to 180 days on Aeson support or after heart transplantation, without disabling stroke or device malfunction requiring reintervention, device replacement, or urgent transplantation.
Positive Results
The primary endpoint was met in 40 of the 55 patients, or 72.7% (95% CI, 57.1%-85.1%), significantly higher than the pre-specified historical threshold of 38% (P < .0001). At baseline, 96% of patients were in New York Heart Association class III or IV; by 180 days, 92% of surviving patients were in class I or II. In addition, 96% of patients were free from disabling stroke, and 76% had been discharged from the hospital by 180 days. The median hospital stay was 54 days.
Among patients evaluable at 6 months, functional recovery was reflected in a median 305-meter improvement on the 6-minute walk test (P < .0002) and a 40-point improvement in the EuroQol Five-Dimension health-related quality-of-life score (P < .0001). No cases of hemolysis were observed, and major bleeding was limited to the first 30 postoperative days; gastrointestinal bleeding occurred in fewer than 4% of patients.
“Self-regulating bioprosthetic TAH provided effective long-term biventricular support in patients with advanced heart failure who were ineligible for a left ventricular assist device, with a low incidence of disabling stroke and hemocompatibility-related complications. Beyond survival, the restoration of functional capacity and hospital discharge demonstrate that TAH treatment is evolving from a rescue strategy toward a more physiological form of heart replacement. Longer-term studies are needed to assess the device’s durability and its potential role beyond bridging to transplantation,” Vincentelli said during the presentation.
“For cardiologists caring for these critically ill patients, the challenge is not limited to survival — it is also to help them recover enough to leave the hospital and regain their independence. In the EFICAS study, more than three quarters of patients had been discharged by 180 days, with significant improvements in walking capacity and quality of life. Treatment with Aeson® is based on a multidisciplinary approach involving cardiologists, surgeons, anesthesiologists, intensive care specialists, and rehabilitation teams. For such critically ill patients, whose treatment options are very limited, these results represent a major breakthrough,” added Anne-Céline Martin, a cardiologist at Hôpital Européen Georges-Pompidou, Paris, and a co-author of the article, in the press release.
CARMAT is now hoping the findings will support reimbursement for the device.
Vincentelli reported serving as a trainer for CARMAT SAS and receiving consulting and training fees from Medtronic. The EFICAS study was funded by CARMAT SAS and the French Ministry of Health (grant SSAH2025903A) and was registered at ClinicalTrials.gov (NCT04475393).
This story was translated from Medscape’s French edition.
