Relief Cardiovascular today announced the successful first-in-human use of its transcatheter smart heart implant.
Irvine, California-based Relief said it’s implant is the world’s first designed to both hemodynamically monitor and treat congestion in heart failure.
The procedures took place in the Republic of Georgia as part of a feasibility study evaluating the system’s safety. Dr. Tamaz Shaburishvili, Dr. Levan Sulakvelidze, and Dr. Gigi Shaburishvili performed the implants at Tbilisi Heart and Vascular Center with support from Dr. Alex Rothman, Professor of Cardiology at the University of Sheffield. The doctors reported patient discharges to their homes with their implanted system automatically syncing with the cloud nightly.
Relief’s 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 earlier this year raised $12 million to support the technology and the first-in-human cases.
Rothman said the first-in-human procedures mark “a major step forward in managing congestion at scale.”
“Achieving first-in-human use is a major milestone for Relief Cardiovascular and a testament to the strength of our clinical and engineering teams. 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,” said Alex Cooper, CEO of Relief Cardiovascular. “These procedures mark the beginning of that future.”
