Aeson® Shows Strong Survival and Recovery in Largest French Bridge‑to‑Transplant Study

72.7% of patients reached the 180‑day endpoint, paving the way for French reimbursement

Patients with end‑stage biventricular heart failure faced imminent death while waiting for a donor heart, received the Aeson® total artificial heart as a bridge‑to‑transplant between December 2022 and May 2025.

The EFICAS trial enrolled 55 critically ill adults across ten French hospitals.

Median age was 56, and nearly half arrived in INTERMACS profile 1 or 2, meaning cardiogenic shock or rapid decline despite medication.

“The primary endpoint was achieved in 40 of the 55 patients,” the study report states.

At six months, survivors walked an extra 305 metres in the six‑minute test and reported a 40‑point jump in EQ‑5D quality‑of‑life scores.

Only one disabling stroke occurred, and major bleeding was limited to the first month after surgery.

Sources & Further Reading

Financial Content — EFICAS Study Results Confirm the Clinical Performance of the Aeson® Total Artificial Heart as a Bridge-to-Transplant Therapy

What the Numbers Mean

The 72.7% success rate dwarfs the 38% historical benchmark for older total artificial hearts, suggesting a real leap in safety and efficacy.

Patient Experience

Most survivors left the hospital within three months and reported NYHA class I or II status, indicating they could resume everyday activities with little limitation.

What Happens Next

on or before December 31, 2026 — French health‑technology assessment agency expected to issue a reimbursement decision.
on or before December 31, 2027 — CARMAT plans to expand enrollment to additional European centers.

The EFICAS trial’s multicenter design, spanning ten leading French hospitals, provided a robust data set that reflects real‑world clinical practice. By enrolling patients across diverse geographic and institutional settings, the study mitigated site‑specific biases and strengthened the generalizability of its findings.

Looking ahead, the strong survival and functional outcomes reported here are expected to influence not only French reimbursement policy but also broader European regulatory discussions. If the upcoming health‑technology assessment confirms these results, other nations may adopt similar pathways, accelerating access to the Aeson® total artificial heart for patients awaiting transplantation.