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

Projektinformationen

PULSE

ID Finanzhilfevereinbarung: 101218281

DOI

10.3030/101218281

EK-Unterschriftsdatum 13 Mai 2025

Startdatum 1 Juni 2025

Enddatum 31 Mai 2027

Finanziert unter

• The European Innovation Council (EIC)

Gesamtkosten

Keine Daten

EU-Beitrag

€ 2 499 999,00

Koordiniert durch

NEURESCUE APS
Denmark

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

Berichtszeitraum: 2025-06-01 bis 2026-01-31

Zusammenfassung vom Kontext und den Gesamtzielen des Projekts

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.

Arbeit, die ab Beginn des Projekts bis zum Ende des durch den Bericht erfassten Berichtszeitraums geleistet wurde, und die wichtigsten bis dahin erzielten Ergebnisse

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.

Fortschritte, die über den aktuellen Stand der Technik hinausgehen und voraussichtliche potenzielle Auswirkungen (einschließlich der bis dato erzielten sozioökonomischen Auswirkungen und weiter gefassten gesellschaftlichen Auswirkungen des Projekts)

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