Pioneering Unprecedented Life-Saving Equipment: Intelligent Aortic Balloon Catheter for Cardiac Arrest

Project Information

PULSE

Grant agreement ID: 101218281

DOI

10.3030/101218281

EC signature date 13 May 2025

Start date 1 June 2025

End date 31 May 2027

Funded under

• The European Innovation Council (EIC)

Total cost

No data

EU contribution

€ 2 499 999,00

Coordinated by

NEURESCUE APS
Denmark

Periodic Reporting for period 1 - PULSE (Pioneering Unprecedented Life-Saving Equipment: Intelligent Aortic Balloon Catheter for Cardiac Arrest)

Reporting period: 2025-06-01 to 2026-01-31

Summary of the context and overall objectives of the project

Cardiac arrest causes 45% of 17.9M annual cardiovascular deaths. Survival is stagnant at ~10% (and ~4% for non-shockable rhythms) because CPR provides only 35% of necessary blood flow. NEURESCUE is the first automated Aortic Balloon Occlusion (ABO) system that redistributes blood to the heart and brain, extending the resuscitation window from 20 to 60 minutes. The PULSE project’s ARISE trial (Germany, Spain, France) provides pivotal safety/efficacy data for global regulatory authorization. Impact: Potential to save 315,468 lives annually and generate €13.9B in productivity gains, aligning with EU health priorities and SDG 3.

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

PULSE reached TRL 7, validated by a feasibility study showing a 20% ROSC rate and 20% rhythm conversion rate.

WP2: Finalized Clinical Investigation Protocols and manufacturing of sensor-embedded catheters.

WP3: Ongoing ARISE trial (84 patients) to prove efficacy in non-shockable arrest.

WP4: Leveraged 2021 FDA 510(k) clearance to synthesize trial data for global Class III compliance. The project successfully transitioned from GLP porcine models to multi-center human clinical enrollment.

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)

NEURESCUE triples the critical resuscitation window and improves blood redistribution compared to standard ALS. Innovation highlights include a patented sensor system enabling safe catheter positioning without fluoroscopy, making ABO portable. Key Achievement: Secured Class III CE mark from TÜV SÜD (Q3 2025). Future Needs: Completion of ARISE for clinical guideline inclusion, pursuing FDA De Novo authorization, and establishing reimbursement (e.g. NTAP) and global distribution partnerships.

The NEURESCUE device