AQUAPASS Wraps REFORM-HF Trial for Novel Heart Failure Therapy

The ECCON System represents a shift in managing fluid overload, a condition that frequently leads to hospital readmissions for patients with kidney disease or heart failure. Unlike standard treatments that rely on kidney function, the AQUAPASS technology targets the extravascular space to remove fluid directly through the skin. The pivotal trial, registered as NCT06360380, enrolled patients across 11 clinical sites in the United States and Israel, utilizing a study design where each participant serves as their own control.

Dr. Feitell, the trial’s principal investigator at Rochester Regional Health, noted that the device offers a potential alternative for patients who have exhausted existing treatment options. Currently, over 40% of patients are discharged while still in a congested state, a statistic that highlights the limitations of current medical standards. Following the data presentation this autumn, AQUAPASS intends to submit its findings to a peer-reviewed journal and continue regulatory discussions with the FDA. The company has already secured two FDA Breakthrough Device Designations for its technology, which remains investigational as it moves toward potential marketing clearance.