Relief Cardiovascular has announced positive 90-day results from a study of its smart heart implant technology.
Irvine, California-based Relief Cardiovascular develops device-based therapy solutions for heart failure (HF) congestion. It says its implant is the world’s first designed to both hemodynamically monitor and treat congestion in heart failure.
The system features a pressure-guided active valve implanted in the vena cava. It dynamically reduces cardiac preload and enhances renal vein flow on demand. The company says that the system integrates hemodynamic monitoring with an adaptive hemodynamic therapy into a single transcatheter implant. This introduces “a new paradigm” in heart failure with direct, personalized decongestion through a data-driven therapeutic implant.
The approach to volume management addresses the unmet needs of diuretic-resistant heart failure. Its system can provide actionable data for optimizing fluid management for tailored, device-driven intervention. Relief last year raised $12 million to support the technology and the first-in-human cases. It announced the first human use of the implant in September 2025.
More about the study findings
Relief Cardiovascular is now sharing results from the prospective, multi-center RELIEF-FIH study of its implant. Dr. Alex Rothman, professor of cardiology at the University of Sheffield, presented findings at the Technology and Heart Failure Therapeutics (THT) 2026 Conference in Boston.
The study evaluated eight patients across three European sites. It saw 100% procedural success, with a seven-minute average time from introducer insertion to removal post-implant. The implant delivered a favorable safety profile at 30 and 90 days with no device-related adverse events.
Investigators reported accurate hemodynamic measurement at 90 days compared to right heart catheterization data. They also saw sustained on-demand renal flow enhancement and pressure reduction with valve action at 90 days.
Additional findings included 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 subjects over the 90 days. Investigators saw a reduction in heart failure hospitalizations compared to baseline, supporting device-based congestion management’s potential.
Commentary from Relief Cardiovascular officials and the study presenter
Alex Cooper, CEO of Relief Cardiovascular, said:
“Sharing our positive FIH data is a significant milestone for the company and validates the promise of our integrated solution to driving decongestion based on venous hemodynamics. Our FIH study lays a foundation as we expand our clinical experience to demonstrate the safety, functional, and efficacy benefits of the Relief system to reduce congestion in heart failure.”
Rothman added:
“The RELIEF-FIH study provides encouraging early evidence on a novel approach to HF congestion management. By targeting the negative physiological cardiorenal loop, the Relief system modulates venous congestion in response to in vivo hemodynamic data. 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.”
