{"id":5170,"date":"2018-03-19T12:01:29","date_gmt":"2018-03-19T11:01:29","guid":{"rendered":"https:\/\/www.sequanamedical.com\/sequana-medical-announces-publication-results-multicentre-randomized-controlled-study-patients-refractory-ascites-treated-alfapump-system-better-health-relat\/"},"modified":"2022-06-30T15:24:26","modified_gmt":"2022-06-30T13:24:26","slug":"sequana-medical-announces-publication-results-multicentre-randomized-controlled-study-patients-refractory-ascites-treated-alfapump-system-better-health-relat","status":"publish","type":"post","link":"https:\/\/www.sequanamedical.com\/nl\/persberichten\/sequana-medical-announces-publication-results-multicentre-randomized-controlled-study-patients-refractory-ascites-treated-alfapump-system-better-health-relat\/","title":{"rendered":"Sequana Medical Announces Publication of Results of\u00a0Multicentre Randomized Controlled Study: Patients with\u00a0refractory ascites treated with\u00a0alfapump\u00ae system have better health-related quality of\u00a0life as\u00a0compared to\u00a0those treated with\u00a0large volume paracentesis"},"content":{"rendered":"

Zurich, SWITZERLAND \u2013 19. March 2018 — Sequana Medical AG (\u201cSequana Medical\u201d), a commercial stage medical device company and an innovator in the management of liver disease, announces the publication of a multicentre, randomized controlled study in Quality of Life Research (https:\/\/link.springer.com\/journal\/11136<\/a>). <\/p>\n

The study demonstrated that patients with refractory ascites treated with alfa<\/strong>pump\u00ae system have better health-related quality of life as compared to those treated with large volume paracentesis.<\/p>\n

In this multicentre, open-label randomized controlled trial, subjects were randomised to receive the alfa<\/strong>pump\u00ae (AP) or large volume Paracentesis (LVP) (27 AP, 31 SoC). The SF-36v2 and CLDQ scores were compared between the two treatment arms at screening and monthly during treatment. <\/p>\n

At baseline, no differences were seen between the treatment arms (all p\u2009>\u20090.05): age 61.9\u2009\u00b1\u20098.4, 79.3% male, MELD scores 11.7\u2009\u00b1\u20093.3, 85.2% Child\u2013Pugh class B, 70.7% had alcoholic cirrhosis. The mean number of LVP events\/subject was lower in alfa<\/strong>pump\u00ae than LVP (1.1 vs. 8.6, in 6 months after treatment; p\u2009<\u20090.001). The health-related quality of life (HRQL) scores showed a moderate improvement from the baseline levels in subjects treated with alfa<\/strong>pump\u00ae (p\u2009<\u20090.05 for abdominal and activity scores of CLDQ) but not with LVP (all one-sided p\u2009>\u20090.05) in the first 3\u00a0months. Subjects with refractory ascites who were treated with LVP continued to worsen their HRQL and experience no HRQL benefit. In contrast, subjects with refractory ascites who were treated with alfa<\/strong>pump\u00ae system did experience improvement of HRQL as early as 1 month after treatment initiation. In fact, this improvement continued with longer follow-up of those subjects, and clinically meaningful HRQL superiority was noted in multiple domains related to bodily pain, other systemic symptoms, and fatigue. It is also important to note that the superiority of HRQL in patients treated with alfa<\/strong>pump\u00ae remained significant even after controlling for other known predictors of HRQL scores. This supports HRQL-related benefits of alfa<\/strong>pump\u00ae system over LVP.<\/p>\n

Conclusion<\/strong>
\nAs compared to LVP, the use of alfa<\/strong>pump\u00ae system is associated with both a reduction in the number of LVP events and improvement of health-related quality of life.<\/p>\n

\u201cThese results are very encouraging\u201d, commented Professor Rajiv Jalan, Professor of Hepatology at the UCL Medical School, and investigator of the alfa<\/strong>pump\u00ae randomized controlled trial. \u201cRefractory ascites has a marked impact on these patient\u2019s quality of life and the alfa<\/strong>pump\u00ae demonstrated it provides a clinically meaningful improvement of HRQL. This benefit is of particular importance as a poor physical component of QoL in patients with refractory ascites is associated with increased mortality\u201d. <\/p>\n

\u201cWe are very pleased that these results clearly demonstrate that the alfa<\/strong>pump\u00ae delivers better health-related quality of life to refractory ascites patients as compared to those treated with large volume paracentesis\u201d said Ian Crosbie, Chief Executive Officer of Sequana Medical. \u201cImproving the health-related quality of life is one of the key clinical objectives in the management of these patients. We believe that this benefit combined with the significant reduction in the number of LVP \/ subject demonstrates that the alfa<\/strong>pump\u00ae is an important treatment option for the treatment of refractory ascites – a market that is forecast to grow significantly due to NAFLD and NASH.\u201d <\/p>\n

About Refractory Ascites (RA)<\/span>
\nAccumulation 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).<\/p>\n

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.<\/p>\n

About the alfa<\/strong>pump\u00ae<\/span>
\nSequana Medical\u2019s alfapump\u00ae 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 alfa<\/strong>pump\u00ae prevents fluid build-up and its\u2019 possible complications, improving patient quality of life and nutrition, and potentially reducing hospital visits and healthcare costs. The alfa<\/strong>pump\u00ae DirectLink Technology allows clinicians to receive pump performance information and more effectively manage patients treated by the alfa<\/strong>pump\u00ae.<\/p>\n

Over 600 alfa<\/strong>pump\u00ae systems have been implanted and the product is currently commercially available in Europe.<\/p>\n

Contacts:<\/strong>
\nSequana Medical AG
\nSabine Landes
\nMarketing & Communications Manager
\n+41 44 403 55 36, sabine.landes@sequanamedical.com<\/a><\/p>\n

ENDS
\nNote to Editors
\nAbout Sequana Medical:<\/strong><\/p>\n

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.
\nThe first product, alfa<\/strong>pump\u00ae, 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.\u00a0 The alfa<\/strong>pump\u00ae 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.\u00a0 By moving ascites to the bladder, where the body can eliminate it naturally through urination, the alfa<\/strong>pump\u00ae prevents fluid build-up and its possible complications, improving patient quality of life and nutrition, and potentially reducing hospital visits and healthcare costs. The alfa<\/strong>pump\u00ae DirectLink Technology allows clinicians to receive pump performance information and more effectively manage patients treated by the alfa<\/strong>pump\u00ae.\u00a0 The alfa<\/strong>pump\u00ae has received the CE Mark and is commercially available Europe. The alfa<\/strong>pump\u00ae 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.
\nThrough the experience gained from the design, development, manufacture and commercialisation of the alfa<\/strong>pump\u00ae, 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.
\nThe Company is headquartered in Zurich, Switzerland and our investors include NeoMed Management, Life Science Partners, VI Partners, Biomed Invest, Capricorn Health Tech, Entrepreneur\u2019s Fund and Salus Partners.\u00a0 For further information, please visit www.sequanamedical.com<\/a>. <\/p>\n","protected":false},"excerpt":{"rendered":"

Zurich, SWITZERLAND \u2013 19. March 2018 — Sequana Medical AG (\u201cSequana Medical\u201d), a commercial stage medical device company and an innovator in the management of liver disease, announces the publication of a multicentre, randomized controlled study in Quality of Life Research (https:\/\/link.springer.com\/journal\/11136). 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March 2018 — Sequana Medical AG (\u201cSequana Medical\u201d), a commercial stage medical device company and an innovator in the management of liver disease, announces the publication of a multicentre, randomized controlled study in Quality of Life Research (https:\/\/link.springer.com\/journal\/11136). 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