Switzerland-based Sequana Medical has reported a positive outcome from a trial that compared its alfapump (AP) solution with Large Volume Paracentesis (LVP) or standard of care (SoC) in the treatment of refractory ascites.
Alfapump is a fully implantable, programmable, transcutaneously charged, battery-powered pump for the management of refractory ascites.
The multicentre, randomised controlled trial included 58 patients, who are in the mean age of 61.9 years and feature a mean model for end-stage liver disease (MELD) score of 11.7.
According to the study, in patients with refractory ascites, the alfapump reduces the requirement for LVP and shows nutritional benefits compared to SoC.
University College London Liver Failure Group head and Hepatology professor Rajiv Jalan was the principal investigator of the trial, which assessed the safety and efficacy of alfapump against LVP or SoC.
Jalan said: “This first multicentre, randomised controlled trial is a key step in bringing the alfapump into regular clinical use for this patient group that has limited treatment options.
“The accumulation of large ascites volumes and the resulting need for frequent hospital visits for LVP are major problems for these patients, and severely impacts their nutritional status, quality of life and survival.
“I see the alfapump as an important treatment option for these patients."
The latest trial found that, compared with SoC, the median time to first LVP was not reached after six months in the AP group of 27 patients.
There was also a significant improvement in health-related quality of life for alfapump patients as measured by the Chronic Liver Disease Questionnaire (HRQoL).
The alfapump patients were reported to experience more adverse events, which were treatable in most cases. Survival was similar in both the groups.
In addition, 18 patients were included in a nutrition sub-study, which observed the improvements in nutritional parameters for hand-grip strength and body mass index in the alfapump group.