– 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://ots.ch/w2er5) .
The study demonstrated that in patients with refractory ascites, the alfapumpR:
This multicentre, randomized controlled trial assessed safety and efficacy of the alfapumpR (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 alfapumpR group, meaning a significant reduction in LVP requirement for the alfapumpR patients (AP, median not reached; SoC, 15.0 days (95%CI 13.0, 22.0); HR: 0.13, pR 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 alfapumpR group compared with standard of care (p
Compared with standard of care, alfapumpR 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 alfapumpR 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 alfapumpR as an important treatment option for these patients.”
“We are very pleased the study has clearly demonstrated that the alfapumpR 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 alfapumpR“.
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 alfapumpR
Sequana Medical’s alfapumpR 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 alfapumpR prevents fluid build-up and its’ possible complications, improving patient quality of life and nutrition, and potentially reducing hospital visits and healthcare costs. The alfapumpR DirectLink Technology allows clinicians to receive pump performance information and more effectively manage patients treated by the alfapumpR.
Approximately 600 alfapumpR systems have been implanted and the product is currently commercially available in Europe.
Note to Editors
About Sequana Medical:
Sequana Medical is a commercial stage medical device company and an innovator in the management of liver disease.
The first product, alfapumpR, is a fully implantable, programmable, transcutaneously-charged, battery-powered pump for the management of refractory ascites (chronic fluid build-up in the abdomen) due to liver cirrhosis or malignant ascites with a life expectancy of 6 months or less. The alfapumpR is one of the first real alternatives to large-volume paracentesis, a lengthy, invasive and painful procedure that can require weekly hospital visits for drainage of excess fluid. By moving ascites to the bladder, where the body can eliminate it naturally through urination, the alfapumpR prevents fluid build-up and its possible complications, improving patient quality of life and nutrition, and potentially reducing hospital visits and healthcare costs. The alfapumpR DirectLink Technology allows clinicians to receive pump performance information and more effectively manage patients treated by the alfapumpR. The alfapumpR has received the CE Mark and is commercially available in 14 countries. The alfapumpR is currently under evaluation in the US under an IDE study.
Through the experience gained from the design, development, manufacture and commercialisation of the alfapumpR, together with an extensive intellectual property portfolio, Sequana Medical has established an enabling platform for fully implantable fluid-imbalance therapies.
The Company is headquartered in Zurich, Switzerland and our investors include NeoMed Management, VI Partners, Biomed Invest, Capricorn Health Tech, Entrepreneur’s Fund and Life Science Partners. For further information, please visit http://www.sequanamedical.com.
Contacts:Sequana MedicalSabine Landes Marketing & Communications Manager +41-44-403-55-36[email protected]
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