Sequana Medical announces inclusion of alfapump® in EASL Clinical Practice Guidelines and presentation of study demonstrating physical component of QOL is predictor of mortality in refractory ascites
Zurich (ots)
Sequana Medical AG ("Sequana Medical"), a commercial stage medical device company and an innovator in the management of liver disease & malignant ascites, announces two important developments at the recent EASL (European Association for the Study of the Liver) International Liver Congress 2018. First, the inclusion of alfapump® in the EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis1 was announced, and secondly, the study by Macdonald et al reported that the physical component of health-related quality of life ("QoL") is an independent predictor of mortality in refractory ascites patients.
The EASL clinical practice guidelines refer to two alfapump® multicentre safety and efficacy studies demonstrating a significant reduction of the number and volume of paracentesis in patients with advanced cirrhosis and refractory ascites by alfapump®2,3. In addition, a multicentre randomised controlled trial in patients with refractory ascites is cited, showing a reduction in the median number of paracentesis per month by 85 % with respect to large volume paracentesis 4. Nutritional parameters and quality of life were also significantly improved in patients treated with the alfapump® system in this study. The importance of quality of life for patients with severe ascites was demonstrated in a study by Stewart Macdonald et al. The analysis of data of 405 cirrhotic patients with severe ascites that were enrolled in a randomized controlled trial show that the physical component of the health-related quality of life is an independent predictor of mortality in these patients. According to this study, a poor physical component of quality of life in patients with severe ascites is associated with increased mortality.
The multicentre, randomized controlled trial (published in the Journal of Hepatology and Quality of Life Research) and the MOSAIC study (presented at the Annual Meeting of the American Association for the Study of Liver Diseases Annual Meeting 2017) both reported that the alfapump® demonstrated a clinically meaningful improvement of health-related quality of life in patient with refractory ascites.
"It is exciting to see the scientific community has been evaluating the growing clinical evidence that is currently available for the alfapump®. The collaboration with many clinicians to demonstrate the benefits of the alfapump® in multiple studies with different designs (from randomized controlled trials to ?real world? post-market studies) has been a strong focus for us during the last years? said Gijs Klarenbeek, Consulting Chief Medical Officer of Sequana Medical. "It is very rewarding to see this is now leading to the alfapump® now being included in the EASL clinical practice guidelines."
"We are delighted that the alfapump® is included in the EASL clinical practice guidelines. This important step for the alfapump® and Sequana Medical is a clear recognition of the extensive work that has been done in partnership with our partners in the clinical community to demonstrate the benefits that the alfapump® brings to this important patient group" said Ian Crosbie, Chief Executive Officer of Sequana Medical. "The publication by Macdonald et al is exciting as it demonstrates the link between physical component of quality of life and mortality in cirrhotic patients with severe ascites. We have repeatedly demonstrated that the alfapump® improves quality of life, one of the key clinical objectives in the management of these patients."
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®.
Over 650 alfapump® systems have been implanted and the product is currently commercially available in Europe.
About Sequana Medical: Sequana Medical is a commercial stage medical device company and an innovator in the management of liver disease & malignant ascites, and is developing products for the management of heart failure and other fluid imbalance disorders.
The first product, alfapump®, 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 alfapump® 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 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®. The alfapump® has received the CE Mark and is commercially available Europe. The alfapump® is currently under evaluation in the US under an IDE study, and the interim results of the MOSAIC study were presented at the AASLD in October 2017.
Through the experience gained from the design, development, manufacture and commercialisation of the alfapump®, together with an extensive intellectual property portfolio, Sequana Medical has established an enabling platform for the management of heart failure and other fluid-imbalance disorders.
The Company is headquartered in Zurich, Switzerland and our investors include NeoMed Management, Life Science Partners, VI Partners, Biomed Invest, Capricorn Health Tech, Entrepreneur's Fund and Salus Partners. For further information, please visit www.sequanamedical.com.
1 The European Association for the Study of the Liver. EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis. J Hepatol 2018, https://doi.org/10.1016/j.jhep.2018.03.024
2 Bellot P, Welker MW, Soriano G, von Schaewen M, Appenrodt B, Wiest R, et al. Automated low flow pump system for the treatment of refractory ascites: a multi-center safety and efficacy study. J Hepatol 2013;58:922-927.
3 Stirnimann G, Berg T, Spahr L, Zeuzem S, McPherson S, Lammert F, et al. Treatment of refractory ascites with an automated low-flow ascites pump in patients with cirrhosis. Aliment Pharmacol Ther 2017;46:981-991.
4 Bureau C, Adebayo D, Chalret de Rieu M, Elkrief L, Valla D, et al. Alfapump® system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study. J Hepatol 2017;67:940-949.
Contact:
Sequana Medical AG, Sabine Landes, Marketing & Communications Manager
+41 44 403 55 36, sabine.landes@sequanamedical.com