CARMAT's Aeson — the world's most advanced total artificial heart — progresses through US Early Feasibility Study with 42 implants performed in 2024 across Europe.
April 10, 2026
11
min read
By
bioaccess® Team
**Key Takeaways**
- • CARMAT Aeson is the world's most advanced total artificial heart for biventricular heart failure
- • US EFS (NCT04117295): first cohort completed 2021, FDA conditional approval for second cohort April 2025
- • 42 implants in 2024 across France, Germany, and Italy with 7M EUR in sales
- • EFICAS pivotal study enrollment completing 2025
- • US commercial launch target ~2028
**The short answer**
CARMAT's Aeson — the world's most advanced total artificial heart for biventricular heart failure — completed its first US EFS cohort (NCT04117295) in 2021 and received FDA conditional approval for a second cohort in April 2025. Meanwhile, 42 implants across France, Germany, and Italy in 2024 generated ~7M EUR in sales, with the EFICAS pivotal study completing enrollment in 2025 and US commercial launch targeted around 2028. See how early feasibility studies run in Latin America.
What is the Aeson total artificial heart?
CARMAT, a French medical device company, has developed the Aeson total artificial heart (TAH) — widely recognized as the world's most advanced total artificial heart. The Aeson is designed as a bridge-to-transplant therapy for patients suffering from biventricular heart failure who are not candidates for existing mechanical circulatory support devices or heart transplantation.
Unlike ventricular assist devices (VADs) that support only one side of the heart, the Aeson replaces both ventricles entirely, providing complete cardiac output using biocompatible materials and sophisticated physiological algorithms that adapt to the patient's activity level.
How is the US early feasibility study progressing?
The US Early Feasibility Study (NCT04117295) for the Aeson TAH has reached important milestones:
- First cohort of 3 patients completed in 2021
- FDA conditional approval for second cohort granted April 2025
- Enhanced FDA oversight with regular data reviews
- Study designed to generate US clinical evidence for further development
How did the Aeson perform commercially in Europe?
While the US EFS progresses, CARMAT has built substantial commercial experience in Europe. In 2024 alone, the company performed 42 Aeson implants across commercial sites in France, Germany, and Italy, generating approximately 7 million EUR in sales.
| Milestone | Date/Value | Details |
|---|---|---|
| US EFS first cohort | 2021 | 3 patients completed |
| FDA second cohort approval | April 2025 | Conditional approval granted |
| European implants (2024) | 42 implants | France, Germany, Italy |
| 2024 revenue | 7M EUR | Commercial sales |
| EFICAS enrollment | 2025 | Completing enrollment |
| US commercial target | ~2028 | Pending regulatory milestones |
What is the EFICAS pivotal study?
The EFICAS study is CARMAT's European pivotal trial designed to support broader regulatory approval and reimbursement. Enrollment is expected to complete in 2025, providing the definitive clinical dataset for the Aeson TAH's efficacy and safety profile.
When is US commercial launch expected?
CARMAT is targeting US commercial launch around 2028, pending successful completion of the EFS second cohort and subsequent regulatory submissions. The combination of European commercial data and US EFS results will form the foundation of CARMAT's FDA premarket application.
How does bioaccess® support EFS trials in Latin America?
The CARMAT Aeson program illustrates the complex pathway from EFS to commercialization for life-sustaining cardiac devices. bioaccess® supports medtech companies conducting early feasibility studies and first-in-human trials in Latin America, where regulatory timelines and costs provide significant advantages.
- EFS and FIH trial design under FDA guidance (21 CFR 812.28)
- Regulatory submissions across LATAM countries
- Access to world-class cardiac surgical teams
- Full clinical operations and data management
- Post-trial market access via bioaccess® MARKET ACCESS ACCELERATOR™
**Planning an Early Feasibility Study for your cardiac device?**
bioaccess® has supported 50+ medtech companies with EFS and FIH trials in Latin America. Contact bioaccess® today or explore our FIH-12™ process.
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