Het alfapump®-systeem is momenteel niet goedgekeurd in de Verenigde Staten of Canada. In de Verenigde Staten en Canada wordt het alfapump®-systeem momenteel klinisch onderzocht (POSEIDON-studie) en wordt het bestudeerd bij volwassen patiënten met refractaire of terugkerende ascites als gevolg van levercirrose. DSR®-therapie is nog in ontwikkeling en er dient te worden opgemerkt dat eventuele verklaringen met betrekking tot veiligheid en efficiëntie voortkomen uit lopende preklinische en klinische onderzoeken die nog moeten worden afgerond. Er is geen verband tussen de DSR®-therapie en de lopende onderzoeken met het alfapump®-systeem in Europa, de Verenigde Staten of Canada.

Sequana Medical announces publication of results of Multicentre Randomized Controlled Study for the alfapump®

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.

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

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®”

About Refractory Ascites (RA)

Accumulation of ascites is a common complication of cirrhosis and one of the leading reasons for hospital admission. The number of patients with cirrhosis, and therefore ascites is predicted to grow significantly, with much of the growth due to the increasing prevalence of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH)

Approximately 60% of cirrhotic patients develop ascites within 10 years of diagnosis. An estimated 10% of patients with ascites develop refractory ascites, where the ascites cannot be treated with diuretics or restriction of dietary sodium. The most frequent treatment for RA patients is paracentesis, a lengthy, invasive and painful procedure that can require weekly hospital visits for drainage of excess fluid and is associated with poor quality-of-life. This often involves the drainage of over 5 litres of fluid and is termed large volume paracentesis.

About the alfapump®

Sequana Medical’s alfapump® is a fully implantable, programmable, transcutaneously-charged, battery-powered pump for the management of refractory ascites. By moving ascites to the bladder, the body can eliminate it naturally through urination. The alfapump® prevents fluid build-up and its’ possible complications, improving patient quality of life and nutrition, and potentially reducing hospital visits and healthcare costs. The alfapump® DirectLink Technology allows clinicians to receive pump performance information and more effectively manage patients treated by the alfapump®.

Approximately 600 alfapump® systems have been implanted and the product is currently commercially available in Europe.

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