Relief Cardiovascular’s Transcatheter Smart Implant for Congestion in Heart Failure Used in FIH Procedures

October 6, 2025–Relief Cardiovascular, a developer of transcatheter smart implants for the treatment of heart failure, announced the first-in-human (FIH) use of its Relief system, an implant designed to both hemodynamically monitor and treat congestion in heart failure.

According to Relief Cardiovascular, the FIH procedures were part of a feasibility study evaluating the system’s safety.

The company stated that the Relief system features a pressure-guided active valve implanted in the vena cava to dynamically reduce cardiac preload and enhance renal vein flow on demand. Further, it noted that the device integrates hemodynamic monitoring with an adaptive hemodynamic therapy into a single transcatheter implant system to provide direct, personalized decongestion via a data-driven therapeutic implant.

The implantations were performed by Tamaz Shaburishvili, MD, et al at Tbilisi Heart and Vascular Center in Tbilisi, Republic of Georgia, with support from Alex Rothman, MD, Professor of Cardiology at the University of Sheffield in Sheffield, United Kingdom.

Patients were discharged to their homes with their implanted Relief system, noted the company.

“Managing heart failure often feels like aiming at a moving target,” commented Dr. Rothman in Relief’s press release. “In small cohorts of patients, clinical teams track remotely measured pressures and continuously adjust medications to optimize therapy, which has been proven to improve outcomes. However, scaling this manual approach to the millions of heart failure patients in need is a challenge.”

Dr. Rothman continued, “In these FIH procedures, we demonstrated the Relief system’s ability to remotely measure cardiac preload and produce a meaningful reduction in cardiac preload and renal afterload when desired. These procedures represent a major step forward in managing congestion at scale with an intelligent implantable therapeutic system.”