Reprieve System to Treat ADHF Evaluated in FIH Study

December 20, 2024—Reprieve Cardiovascular, Inc., a Massachusetts-based development-stage company focused on the treatment of acute decompensated heart failure (ADHF), recently announced the first-in-human (FIH) results of the Reprieve system.

The company stated that the Reprieve system is intended to personalize decongestion management. The device is designed to remove fluid and sodium through precise administration of diuretics, rapidly finding the optimal dose while delivering the necessary volume of fluid and sodium to support optimal kidney function. The Reprieve system combines real-time physiological monitoring with automated recommendations to escalate or end therapy.

According to the company, the FIH study demonstrated the potential of the Reprieve system to safely accelerate and maximize decongestion while reducing the likelihood of kidney injury for patients with ADHF.

The open-label, single-arm FIH study was intended to evaluate the ability of the Reprieve system to optimally decongest patients with ADHF. The study enrolled 10 patients in Tbilisi, Georgia.

As summarized in the company’s press release, patients in the study were treated with the Reprieve system until completion of therapy, or for a maximum of 72 hours, whichever came first. Follow-up clinical assessments were performed during treatment and post-treatment through 30 days post-discharge. Adverse events were assessed through 30 days.

The study’s primary efficacy endpoint was functional device success, defined as the device’s ability to perform its intended function as specified in the study protocol without any device-related adverse events or malfunctions as determined by the treating physician over the 72-hour maximum duration of therapy.

The company reported that the system successfully facilitated high-volume fluid and sodium removal with an average treatment duration of 18.3 hours and achieved the following: net fluid loss of approximately 4.8 L; average weight reduction of 4.8 kg; and net sodium loss of 653 mmol.

Additionally, kidney function remained stable, no patients developed acute kidney injury, and the average serum creatinine level decreased over the course of therapy, indicating effective decongestion without renal complications. No device or procedure related adverse events were reported through 30 days, noted the company.

The results were presented by Piotr Ponikowski, MD, at the CSI Focus D-HF (Device Therapies in Heart Failure) conference held December 5-6, 2024, in Frankfurt, Germany.

“Heart failure patients with fluid volume overload are particularly challenging to manage due to the difficulty of achieving the right balance in decongestion—thoroughly enough to prevent readmission without damaging the kidney in the process,” commented Dr. Ponikowski in the company’s press release.

Dr. Ponikowski, who is Professor of Cardiology at Wroclaw Medical University in Wroclaw, Poland, continued, “These initial findings demonstrate the potential of the Reprieve system to address the longstanding challenges of ADHF treatment by removing a significant amount of sodium, improving decongestion outcomes, reducing renal injury risks, and potentially shortening hospital stays. As heart failure management continues to evolve, this technology represents a significant step forward in developing precise, patient-centric approaches to decongestion management.”

In October 2024, the company announced completion of enrollment in the FASTR pilot trial assessing the safety and efficacy of the Reprieve system.