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Industry Insights · Artificial Heart & Circulatory Support

Carmat Aeson total artificial heart: design and materials of the EU's only commercial TAH

Unlike an LVAD that only assists the left heart, a total artificial heart (TAH) fully replaces both diseased ventricles, demanding the most of materials and hemocompatibility.

Published:2026-06-01Updated:2026-06-01

Updated
Diagram of TAH biventricular replacement and bio-mimetic blood interface
TAH system: an implanted prosthesis fully replaces both ventricles (2 chambers, 4 biological valves form one-way flow paths), powered by a portable external driver backpack and a hospital console. Blood-contacting surfaces use biological tissue plus an anticoagulant coating. Illustrative.
In short: Carmat's Aeson is currently the EU's only approved commercial total artificial heart (TAH): it gained EU MDR Class III active-implant certification in July 2025 and has been implanted in France, Germany, Spain, Belgium and Israel; in the US it is only in FDA early feasibility study (EFS). It fully replaces both ventricles, each chamber up to ~60mL, using hydraulic flexible membranes for pulsation; all blood-contacting surfaces (membranes plus four valves) use glutaraldehyde-crosslinked bovine pericardium with a phosphorylcholine anticoagulant coating for a bio-mimetic interface that lowers blood foreign-body stress.

System and indication

The system has three units: an implanted prosthesis, a portable external driver backpack (~3–4kg, dual batteries for all-day activity), and a hospital console, linked by an ~8mm percutaneous cable. It is indicated for Intermacs 1–4 end-stage biventricular failure where medication and LVAD bring no benefit and a donor is awaited.

Pulsatile, bio-mimetic design

The implant fully replaces both ventricles, each chamber up to ~60mL, using hydraulic flexible membranes to produce diastolic/systolic pulsation that mimics the natural heart's flow.

The differentiator: the blood interface

Unlike pure metal or polymer mechanical pumps, Aeson's membranes and four valves are made of glutaraldehyde-crosslinked bovine pericardium with a phosphorylcholine anticoagulant coating; this endothelializing bio-mimetic interface markedly lowers blood-to-foreign-body stress.

The BIO angle

Whether biological tissue or polymer mechanical pump, the blood-contacting interface and anticoagulant coating is the make-or-break line for TAH/VAD. Medical silicone, polyurethane and functional coatings have long played key roles in pump sealing, membranes and interface engineering — BIO's advanced-materials focus.

FAQ

How does a TAH differ from an LVAD?

An LVAD assists only the left heart and keeps the native heart; a TAH excises and replaces both ventricles, for biventricular failure.

Why bovine pericardium for the blood interface?

Glutaraldehyde-crosslinked bovine pericardium plus a phosphorylcholine coating forms a bio-mimetic interface that, versus pure mechanical pumps, lowers foreign-body stress and improves hemocompatibility.

Where is it available?

The EU is its core approval region (MDR Class III active implant), with implants in several countries; in the US it is only in FDA early feasibility study.

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Note: an original analysis compiled from public industry information; figures and conclusions per official/original sources. Not investment advice.

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