Relief Cardiovascular Posts Strong 90-Day First-in-Human Data for Heart Failure Decongestion Device

New updates have been reported about Relief Cardiovascular.

Relief Cardiovascular, a privately held medtech company based in Irvine, Calif., reported positive 90-day results from its RELIEF-FIH first-in-human study evaluating its implantable valve-and-sensor system for managing heart failure congestion. The prospective, multi-center trial, conducted in eight patients across three European sites, met primary and functional endpoints, demonstrating procedural safety, sustained on-demand renal vein flow, and accurate automated hemodynamic pressure sensing.

The Relief System is implanted in the inferior vena cava below the renal veins, where it modulates venous pressure and enhances renal perfusion, while streaming daily venous pressure waveforms to a secure cloud platform for hemodynamically guided, home-based therapy. Study data showed 100% procedural success with an average seven-minute implant time, no device-related adverse events at 30 and 90 days, strong correlation of sensor readings with right heart catheterization (R²=0.9), and durable renal flow enhancement and pressure reduction with valve activation, alongside consistent data transmission and therapy delivery in all patients and a reduction in heart failure hospitalizations versus baseline, which CEO Alex Cooper described as a key milestone that supports broader clinical development and the system’s potential to offer a device-based alternative to pharmacologic congestion management, which is often constrained by renal side effects.