US-based Reprieve Cardiovascular has announced that the first-in-human clinical trial of its fully automated fluid management system, Personalized Volume Management System (PVM), has indicated effective and long-lasting decongestion in patients suffering from Acute Heart Failure.
The study, involving 15 patients, evaluated the performance of Reprieve Personalized Volume Management System, designed to reduce net volumes and acute heart failure symptoms.
In the study, Reprieve Personalized Volume Management System normalised the average net fluid removal from 5.9l per therapy to 4.5l per 24 hours.
Furthermore, automated fluid management technology normalised the average sodium removal from 798 mmol per therapy to 611 mmol per 24 hours.
The company also claimed the absence of re-hospitalisation of patients who completed a one-month follow-up.
Designed to accelerate fluid removal and symptomatic relief, the Reprieve Personalized Volume Management System automatically tailors diuretic dosing for each patient. It activates salt and water, retaining renal mechanisms and offers personalised fluid management to prevent hypotension.
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Reprieve Cardiovascular chief medical officer Howard Levin said: “We’re very encouraged by these first in man results with our new Personalized Volume Management System.
“The trends in all of the core metrics that matter to heart failure physicians and patients, including length of stay, weight reduction, and re-hospitalisation point in a positive direction.
“We look forward to continuing this clinical work to support the adoption of PVM as a standard of care for improved treatment of patients with ADHF.”
Acute decompensated heart failure (ADHF) is an onset symptom of heart failure. Due to this condition, patients experience difficulty in breathing (dyspnea), leg or feet swelling and fatigue.
Current treatment for ADHF includes diuretic therapy that aims to restore healthy fluid levels in the kidneys and throughout the body. However, when a patient’s condition deteriorates, standard diuretic therapy can be unpredictable and lose effectiveness while managing the indications of ADHF.