Periodic Reporting for period 1 - PULSE (Pioneering Unprecedented Life-Saving Equipment: Intelligent Aortic Balloon Catheter for Cardiac Arrest)
Periodo di rendicontazione: 2025-06-01 al 2026-01-31
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.
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.
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.
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.