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AQUAPASS Medical’s Breakthrough Therapy for Heart Failure

AQUAPASS Medical recently announced that its pivotal trial, REFORM-HF, achieved its primary effectiveness endpoint, providing hope for patients suffering from heart failure. This groundbreaking study highlighted the efficacy of the AQUAPASS ECCON™ System, a noninvasive, kidney-independent therapy aimed at managing fluid overload in heart failure patients who are unresponsive to conventional treatments.

The REFORM-HF trial, identified by the NCT06360380 code, demonstrated that the AQUAPASS ECCON™ System can lead to over seven times greater fluid loss in patients who have not responded well to high doses of diuretics. Impressively, the trial boasted a consistent responder rate of 91% without any device-related adverse events, marking a significant breakthrough in the treatment landscape.

The details of this pivotal study were presented during a Late-Breaking Rapid Fire Scientific Session at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026, steered by Dr. Scott Feitell from Novant Health Presbyterian Hospital. The outcomes also featured in various prestigious national meetings such as the American Society of Nephrology (ASN) Kidney Week, AdvaMed, and the TCT Acute Heart Failure Innovation Session.

Understanding Fluid Overload in Heart Failure

In the context of heart failure, congestion is a common and challenging issue, resulting in over one million hospital admissions in the United States each year. Patients with chronic heart failure often face the distressing reality of persistent congestion despite utilizing high-dose loop diuretics, and approximately 75% of participants in the REFORM-HF trial had chronic kidney disease (CKD) stage 3 or 4. This group represents a community in dire need of innovative decongestive therapies.

The trial confirmed a mean increase of 785 grams in net fluid loss compared to each patient's control day, surpassing the 500 grams threshold with a statistical significance of p < 0.0001. Notably, the response remained consistent across treatment days regardless of the patients' baseline kidney function.

Innovative Noninvasive Approach

The AQUAPASS ECCON™ System utilizes a unique approach to manage fluid removal through sweat via a wearable garment. This non-invasive method provides an alternative for fluid management that does not rely on the kidneys, addressing a critical need in heart failure treatment. Traditional diuretics can become ineffective over time, with over 40% of patients being discharged congested, leading to a 25% readmission rate within 30 days.

Dr. Feitell shared his enthusiasm regarding the trial’s findings, stating, "Fluid overload remains one of the most difficult problems we manage in heart failure. In REFORM-HF, the ECCON System delivered consistent, meaningful fluid removal through the skin, regardless of kidney function. These are very exciting results for heart failure patients who often have few options left."

The study's principal investigator, Noam Josephy, MD, emphasized, "REFORM-HF was designed to answer a clear question, and the trial met its primary endpoint by a strong margin. We are grateful to the patients, investigators, and site teams who put Patients First at every step of this trial. We are now focused on our De Novo submission to the FDA."

With the successful completion of the REFORM-HF pivotal study, AQUAPASS is gearing up for its De Novo submission to the U.S. Food and Drug Administration (FDA) concerning the ECCON System. It’s important to note that as an investigational device, it has not yet received FDA approval, and it remains unavailable for sale within the United States.

About AQUAPASS

AQUAPASS is at the forefront of revolutionizing fluid overload therapy. The company’s innovative approach with the ECCON System provides kidney-independent decongestion solutions for heart failure patients. With a steadily expanding intellectual property portfolio, AQUAPASS has also attained two FDA Breakthrough Device Designations.

For further insights, visit the official AQUAPASS Medical website: www.aquapass-medical.com.