Relief Cardiovascular’s RELIEF-FIH Meets All 3-Month Endpoints

March 9, 2026—Relief Cardiovascular, Inc. announced 90-day results from the first-in-human (FIH), prospective, multicenter RELIEF-FIH study of the Relief system for the treatment of heart failure (HF) congestion. The study, which commenced in October 2025, is composed of eight patients at three sites in Europe.

The Relief system is an integrated valve-and-sensor implant positioned in the inferior vena cava below the renal veins to directly modulate venous pressure and increase renal perfusion, noted the press release.

According to the company, all study endpoints were met, confirming procedural safety, sustained on-demand renal vein flow, and accuracy of the system’s automatic hemodynamic pressure measurements.

As outlined in the company’s press release, the RELIEF-HIF study demonstrated the following:

• 100% procedural success, with a 7-minute average time from introducer insertion to removal post implantation
• A favorable safety profile at 30 and 90 days with no device-related adverse events
• Accurate hemodynamic measurement (R₂ = 0.9) at 90 days, as compared to right heart catheterization data
• Sustained on-demand renal flow enhancement and pressure reduction with valve activation at 90 days

Additional findings confirmed seamless daily transmission of hemodynamic data, consistent valve performance, and successful delivery of hemodynamically guided therapy through the system’s cloud-enabled interface in 100% of patients during the 90 days. Finally, a reduction in HF hospitalizations compared to baseline was observed across the study cohort, supporting the potential for device-based congestion management, noted the company.

Alex Rothman, MD, who is Professor of Cardiology at the University of Sheffield in Sheffield, United Kingdom, presented the findings at THT 2026, the Technology and Heart Failure Therapeutics conference.

“The RELIEF-FIH study provides encouraging early evidence on a novel approach to HF congestion management,” commented Prof. Rothman in the company’s press release. “By targeting the negative physiological cardiorenal loop, the Relief system modulates venous congestion in response to in vivo hemodynamic data.”

Prof. Rothman continued, “Early study data demonstrated sustained renal flow enhancement. The ability to actively drive decongestion while supporting renal function may represent a significant advancement over pharmaceutical strategies, which are often constrained by renal impact.”