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

Informacje na temat projektu

PULSE

Identyfikator umowy o grant: 101218281

DOI

10.3030/101218281

Data podpisania przez KE 13 Maja 2025

Data rozpoczęcia 1 Czerwca 2025

Data zakończenia 31 Maja 2027

Finansowanie w ramach

• The European Innovation Council (EIC)

Koszt całkowity

Brak danych

Wkład UE

€ 2 499 999,00

Koordynowany przez

NEURESCUE APS
Denmark

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

Okres sprawozdawczy: 2025-06-01 do 2026-01-31

Podsumowanie kontekstu i ogólnych celów projektu

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.

Prace wykonane od początku projektu do końca okresu sprawozdawczego oraz najważniejsze dotychczasowe rezultaty

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.

Innowacyjność oraz oczekiwany potencjalny wpływ (w tym dotychczasowe znaczenie społeczno-gospodarcze i szersze implikacje społeczne projektu)

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