CARMAT Aeson Total Artificial Heart: Early Feasibility Study Advances in the United States

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

Trial overview: 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.

US Early Feasibility Study progress

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

42 implants across Europe in 2024

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.

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.

Path to US commercial launch ~2028

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.

bioaccess® and Early Feasibility Studies 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 FastTrack process.

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