Reprieve Cardiovascular has designed the PVM System to advance the fluid removal and symptom relief using very less diuretic dose for each patient
Image: Reprieve unveils clinical data from study of PVM device. Photo: Courtesy of valelopardo from Pixabay.
US-based medical device company Reprieve Cardiovascular has unveiled the results from the clinical trial of its second-generation personalized volume management system (PVM) device.
The clinical trial of a PVM device involving 15 patients is aimed at evaluating effectiveness and safety of the system in reducing the net volume and Acute Heart Failure (AHF) symptoms.
The study showed that the fully automated fluid management system facilitated safe, effective, and long-lasting decongestion for acute decompensated heart failure (ADHF) patients.
PVM device is designed to better manage diuretic therapy for patients with ADHF
ADHF is characterised by onset of unexpected heart failure symptoms, including difficulty breathing (dyspnea), swelling in the extremities, and fatigue.
Current treatment for ADHF includes diuretic therapy, which is intended to restore healthy fluid levels in the kidneys and throughout the body. However, diuretic therapy could be unpredictable and lose effectiveness, with the worsening of patient condition.
In addition, diuretics may potentially trigger a condition called ‘diuretic resistance’ in some patients, characterised by reduction in function of diuretics and worsening of fluid overload severity, resulting in acute kidney injury.
Reprieve Cardiovascular has designed the PVM System to accelerate the fluid removal and symptom relief using very less diuretic dose for each patient.
The system automatically customises diuretic dosing for each patient.
Besides, it offers personalised fluid management to prevent hypotension and the activation of salt- and water-retaining renal mechanisms.
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-hospitalization 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.”