The first Total Artificial Heart (TAH) that truly mimics the human heart and has the potential to revolutionise the market

Project Information

ArtOfHeart

Grant agreement ID: 190157517

DOI

10.3030/190157517

Project closed

EC signature date 1 August 2022

Start date 1 April 2022

End date 31 March 2026

Funded under

• The European Innovation Council (EIC)

Total cost

€ 38 241 965,75

EU contribution

€ 2 500 000,00

Coordinated by

SCANDINAVIAN REAL HEART AB
Sweden

Periodic Reporting for period 2 - ArtOfHeart (The first Total Artificial Heart (TAH) that truly mimics the human heart and has the potential to revolutionise the market)

Reporting period: 2023-10-01 to 2025-03-31

Summary of the context and overall objectives of the project

The Realheart TAH system (RTS) is the first total artificial heart designed to mimic the structure and function of the human heart. Its unique patented construction of two atria and two ventricles is separated by an atrioventricular plane which contains the valves, enabling to pump blood naturally whilst reducing the risk of blood flow complications. RTS is designed to be efficient (12h battery), silent, lightweight (1-2kg), easy to implant and automatically adapt to different (physiological) activity levels. It consists of two identical artificial heart pumps, a drive line and an intelligent control unit. RTS is connected via a cable through the skin to a controller with integrated batteries. Depending on the outcome of patient usability studies, the system will be offered with an optimal carrying solution, which could for example be a backpack or belt around the waist. RTS is initially aimed for end-stage heart failure patients waiting for a transplant, but the bigger project impact is delivered by the second application which is to offer the system to the large majority of heart failure patients that do not qualify for the heart transplant waiting list. Realheart will complete GLP animal trial, clinical trial preparatory activities and first-in-man (EFS) trial during the EIC project.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Clinical controller product vision completed, with projected lower weight than initially anticipated (2 kg) at the same long battery life (12 hours). The integrated battery design implies patients will handle fewer cables (1 instead of 3), as well as fewer external components (1 instead of 3) compared to solutions in current technical use. This is expected to give patients a better quality of life.

In vivo results are similar to those achieved by market competitors prior to them initiating clinical trials. Work is ongoing to optimise animal care protocol as this is complicated and has been identified to be a unique area of expertise held by a small group of individuals in the world (and outside of Europe).

In vitro human blood hemolysis testing against the current market-leading device in a more advanced test rig that mimics full body circulation achieved.

A collaboration with Swedish start-up company InvivoPower was initiated since they received grant funding from Vinnova. This resulted in the first proof-of-concept of wireless energy transfer via the skin for our RTS system.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

In vitro human blood hemolysis testing ongoing and initial results show RTS system produces only one fifth of the blood damage compared to the product in current clinical use. We expect that this can translate to fewer blood-related side effects in the patients.

The work on the electronic architecture of the RTS system is expected to result in a thin, flexible power cable (driveline through the skin). This could translate to reduced infection risk in the patient compared to solutions in current clinical use.

The first proof-of-concept of wireless energy transfer via the skin for our RTS system is expected to result in reduced infection risk in the patients.
Realheart is being tested by the Royal Institute of Technology in Sweden in a comparative study against the marketleading SynCardia TAH. The results to date show that Realheart TAH better adapts the cardiac output to exercise and sleep versus the marketleader.

Realheart TAH system (RTS) size as compared against apple

Realheart TAH system (RTS) on human