Relief Cardiovascular, a private company developing transcatheter smart implants to transform the treatment of heart failure, today announced the successful first-in-human use of the Relief System – the world’s first implant designed to both hemodynamically monitor and treat congestion in heart failure.
The breakthrough procedures were performed in the Republic of Georgia as part of a feasibility study evaluating the system’s safety. Implantations were carried out by Dr. Tamaz Shaburishvili, Dr. Levan Sulakvelidze, and Dr. Gigi Shaburishvili at Tbilisi Heart and Vascular Center, with support from Dr. Alex Rothman, Professor of Cardiology at the University of Sheffield. Patients were discharged to their homes with their implanted Relief System automatically syncing with the cloud nightly.
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. By integrating hemodynamic monitoring with an adaptive hemodynamic therapy into a single transcatheter implant system, the Relief System introduces a new paradigm in heart failure: direct, personalized decongestion via a data-driven therapeutic implant.
“Managing heart failure often feels like aiming at a moving target,” said Dr. Alex Rothman. “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. In these first-in-human 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.”
“Achieving first-in-human use is a major milestone for Relief Cardiovascular and a testament to the strength of our clinical and engineering teams,” said Alex Cooper, Chief Executive Officer of Relief Cardiovascular. “Seeing the immediate, tunable hemodynamic effect in our treated patients strengthens our conviction that data-driven therapeutic implants represent the future of heart failure treatment. These procedures mark the beginning of that future.”