German-American medical device firm, Reprieve Cardiovascular, is eyeing up a pivotal trial with its cardiovascular drainage device after reporting success from a first-in-human study.
Results from the open-label, single-arm study (NCT03897842), presented at the Device Therapies in Heart Failure Conference in Munich, found that the company’s system was able to facilitate high-volume fluid and sodium removal with an average treatment duration of 18.3 hours, resulting in a net fluid loss of 4.8l. The device was investigated in patients with advancing acute decompensated heart failure (ADHF).
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At the same time, the company said that throughout the trial, kidney function remained stable with no patients suffering from acute kidney injury as a result of the treatment. The trial examined the system in ten patients from Tbilisi, Georgia. Follow-up clinical assessments were performed during treatment and post-treatment through 30 days post-discharge.
The company claims that its Reprieve System works to improve patient outcomes and prevent hospital readmissions by decongesting the cardiovascular system through the precise administration of diuretics. At the same time, the company touts its devices’ ability to carry out real-time physiological monitoring with automated recommendations to escalate or end therapy.
Presenting the results before the conference on behalf of the company, Piotr Ponikowski, professor of cardiology at Wroclaw Medical University, said: “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.”
Often conditions such as ADHF present with symptoms such as difficulty breathing, leg or foot swelling, and fatigue, all of which are liable to prompt an emergency hospital visit. Research by the American Heart Association found that on average, nearly one in four patients are readmitted to the hospital within 30 days to address fluid volume overload, and approximately half are readmitted within six months. The company has also completed enrollment on its US-based FASTR pilot trial.
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By GlobalDataMark Pacyna, chief executive officer of Reprieve Cardiovascular, said: “We are encouraged by these initial results from the first-in-human study of the Reprieve System, which demonstrate its potential to enable clinicians to manage fluid overload safely and efficiently.
“We know greater sodium removal improves short and long-term outcomes for ADHF patients. We were also thrilled to complete enrollment in our US FASTR pilot trial earlier this year and look forward to sharing those results in early 2025, with the goal of further validating the findings from this First-In-Human study of the Reprieve System.
“Looking ahead, we aim to prove the full potential of the Reprieve System in a global pivotal study next year, marking an important step toward our mission of transforming decongestion management for acute heart failure patients.”
Elsewhere in the field of cardiovascular condition, Novartis has reported positive topline outcomes from its multicentre Phase IIIB APPULSE-PNH trial of oral Fabhalta for treating adults with paroxysmal nocturnal haemoglobinuria (PNH). Meanwhile, Dutch late-stage clinical biopharma company, New Amsterdam, has unveiled positive topline data from the company’s Phase III TANDEM trial.
