Questions & answers

An independent preclinical research and development project from Freiburg for a compact, pulsatile artificial heart.

No. This is non-clinical / benchtop research — not an approved medical device, no treatment, no medical advice.

The current development architecture combines a pulsatile chamber for the systemic circulation with a smaller pulse chamber and a continuous-flow pump for the pulmonary circulation. Details: System architecture.

The systemic circulation needs higher pressure and larger volume, the pulmonary circulation runs at much lower pressure. A single chamber for both jobs would either overload the lungs or under-supply the body.

Several drive principles are designed and compared on the test rig under identical conditions; none has been chosen yet. More under Drive.

Not according to the concept: the membrane keeps blood space and drive separate, and no dynamic shaft or piston-rod seal through the blood space is planned.

Several separate functional paths and reserve functions are planned. None of this is validated. See Safety & redundancy.

This is the subject of a separate R&D project. Single- and multilayer membranes made of PU/PCU, BPU, silicone and EPDM are being investigated. A material only counts as selected once endurance data exist. See Membrane research.

The membrane is designed for several hundred million load cycles. That is a target — there is no validated lifetime.

The goal is that the system fits the pericardium of the large majority of adults; its shape is therefore oriented on the human heart. Battery, electronics and energy transfer sit outside the pericardium. A smaller model with lower output is planned for children.

The idea and preparatory work go back several years. Membrane development runs as a separate, documented R&D project. The development steps are shown in the development path.

Earlier architecture stages stay visible in the development path and are marked as “earlier stage”. They have been superseded by the current architecture.

Pressure, temperature and runtime have been measured on the existing circulatory bench. Volumetric flow is calculated, not measured. There are no blood tests, no haemolysis data and no standards-compliant tests. The full overview is under overview of what is and is not measured.

Material validation, sterilisation strategy, biocompatibility, hemocompatibility, electrical safety, software validation, risk management and long-duration evidence — none of which exists yet.