Sequana Medical AG (“Sequana Medical), a commercial stage medical device company and an innovator in the management of liver disease, announces the publication of a multicentre, randomized controlled trial in the Journal of Hepatology (http://www.journal-of-hepatology.eu/article/S0168-8278(17)32080-9/ppt). 

The study demonstrated that in patients with refractory ascites, the alfapump^®:

• significantly reduces the requirement for LVP compared to standard of care
• significantly improves Health-Related Quality of Life compared to standard of care
• shows nutritional benefits compared to standard of care

This multicentre, randomized controlled trial assessed safety and efficacy of the alfapump^® (AP) compared with Large Volume Paracentesis (LVP or SoC) in 58 patients (27 AP, 31 SoC, mean age 61.9 years, mean MELD 11.7).

Compared with standard of care (SoC), median time to first LVP was not reached after 6 months in the alfapump^® group, meaning a significant reduction in LVP requirement for the alfapump^® patients (AP, median not reached; SoC, 15.0 days (95%CI 13.0, 22.0); HR: 0.13, p<0.001).  In addition, there was a significant improvement in quality-of-life for alfapump^® patients as measured by the Chronic Liver Disease Questionnaire (HRQoL) score compared to standard of care (p<0.05 between treatment arms).

Eighteen patients were included in a nutrition sub-study. Improvements in nutritional parameters were observed for hand-grip strength (p=0.044) and body mass index in the alfapump^® group compared with standard of care (p<0.001).

Compared with standard of care, alfapump^® patients reported more adverse events, which were treatable in most cases. Survival was similar in both groups.

Professor Jalan, Principal Investigator of the trial and Professor of Hepatology, Head of the Liver Failure Group, ILDH, UCL and Royal Free Hospital, London  commented “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.”

“We are very pleased the study has clearly demonstrated that the alfapump^® delivers important benefits to patients with this key complication of liver disease” said Ian Crosbie, Chief Executive Officer of Sequana Medical. “Through our ongoing development work and close collaboration with clinicians, we continue to further improve the performance of the alfapump^®”