Reprieve Cardiovascular, Inc., a company focused on developing treatments for acute decompensated heart failure (ADHF), announced today the first-in-human results of the Reprieve System at the CSI Focus D-HF (Device therapies in heart failure) conference in Frankfurt, Germany. The study results highlighted the Reprieve System’s potential to safely accelerate decongestion and optimize fluid removal, while also reducing the risk of kidney injury in patients with ADHF.
Reprieve Cardiovascular, Inc. has announced promising results from the first-in-human study of its Reprieve System, designed to enhance the treatment of acute decompensated heart failure (ADHF). Presented at the CSI Focus D-HF (Device therapies in heart failure) conference in Frankfurt, Germany, the study results highlighted the Reprieve System’s potential to optimize decongestion management in heart failure patients by safely removing excess fluid and sodium while reducing the risk of kidney injury.
Dr. Piotr Ponikowski, Professor of Cardiology at Wroclaw Medical University in Poland, who presented the findings, explained, “Heart failure patients with fluid volume overload are particularly challenging to manage due to the difficulty of achieving the right balance in decongestion. The Reprieve System’s ability to effectively remove sodium, improve decongestion outcomes, reduce renal injury risks, and potentially shorten hospital stays is a significant step forward in managing ADHF.”
ADHF is a condition marked by the sudden onset of symptoms like shortness of breath, leg swelling, and fatigue. It often leads to unplanned hospital visits and admissions, with patients typically staying in the hospital for over five days. Fluid overload, a common issue in ADHF, can result in frequent readmissions, with nearly one in four patients returning to the hospital within 30 days and about half being readmitted within six months. Diuretics, the standard treatment for fluid removal, are difficult to administer precisely without real-time data on patient response, leading to complications such as kidney injury, prolonged stays, and inadequate fluid removal at discharge.
The Reprieve System was developed to address these challenges by personalizing decongestion management. It works by accurately administering diuretics to remove excess fluid and sodium, optimizing fluid balance while supporting kidney function. The system integrates real-time physiological monitoring with automated treatment adjustments, allowing healthcare providers to tailor therapy to each patient’s needs. This approach aims to improve patient outcomes, reduce hospital readmissions, and ease clinician workloads.
The first-in-human study of the Reprieve System was conducted in Tbilisi, Georgia, with 10 patients enrolled. Participants received therapy with the Reprieve System until the completion of treatment or for a maximum of 72 hours. Follow-up assessments were conducted during and after treatment, with adverse events monitored for 30 days. The primary endpoint was the functional success of the device, defined as its ability to perform as intended without any device-related adverse events.
The Reprieve System achieved notable results, including:
- A net fluid loss of approximately 4.8 liters,
- An average weight reduction of 4.8 kg,
- A net sodium loss of 653 mmol.
Importantly, kidney function remained stable throughout the treatment, with no instances of acute kidney injury. The average serum creatinine level decreased, indicating effective decongestion without renal complications. No device-related adverse events were reported during the study period.
Mark Pacyna, CEO of Reprieve Cardiovascular, expressed optimism about the results, stating, “These initial findings demonstrate the potential of the Reprieve System to enable clinicians to manage fluid overload safely and effectively. We’re excited to have completed enrollment in our U.S. FASTR pilot trial and look forward to sharing those results in early 2025. We aim to validate the findings from this study and further prove the Reprieve System’s potential in a pivotal global study next year.”
Reprieve Cardiovascular remains committed to transforming the management of heart failure and improving outcomes for the millions of patients worldwide affected by the condition.
About Heart Failure
Heart failure, a significant and growing public health issue, affects over 6.7 million Americans. Acute decompensated heart failure leads to over one million hospital admissions annually in the U.S., with nearly 25% of patients readmitted within 30 days, highlighting the need for improved management strategies.
About Reprieve Cardiovascular, Inc.
Reprieve Cardiovascular is a company focused on developing innovative technologies for heart failure treatment. Their groundbreaking therapies aim to improve decongestion management and enhance the quality of life for millions of heart failure patients worldwide. Based in Milford, Massachusetts, Reprieve Cardiovascular is dedicated to advancing solutions for the complex challenges of heart failure management.
