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 cirrose. Voor meer informatie over de POSEIDON klinische studie zie www.poseidonstudy.com.
De 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.
De DSR-therapie is momenteel niet goedgekeurd voor klinisch onderzoek in de Verenigde Staten of Canada. Er is geen verband tussen de DSR-therapie en de lopende onderzoeken met het alfapump®-systeem in Europa.

Sequana Medical Announces Publication of Results of Multicentre Randomized Controlled Study

Zurich, SWITZERLAND – 19. March 2018 — 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 study in Quality of Life Research (https://link.springer.com/journal/11136).

The study demonstrated that patients with refractory ascites treated with alfapump® system have better health-related quality of life as compared to those treated with large volume paracentesis.

In this multicentre, open-label randomized controlled trial, subjects were randomised to receive the alfapump® (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

At baseline, no differences were seen between the treatment arms (all p > 0.05): age 61.9 ± 8.4, 79.3% male, MELD scores 11.7 ± 3.3, 85.2% Child–Pugh class B, 70.7% had alcoholic cirrhosis. The mean number of LVP events/subject was lower in alfapump® than LVP (1.1 vs. 8.6, in 6 months after treatment; p < 0.001). The health-related quality of life (HRQL) scores showed a moderate improvement from the baseline levels in subjects treated with alfapump® (p < 0.05 for abdominal and activity scores of CLDQ) but not with LVP (all one-sided p > 0.05) in the first 3 months. 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 alfapump® 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 alfapump® remained significant even after controlling for other known predictors of HRQL scores. This supports HRQL-related benefits of alfapump® system over LVP.

Download the full press release.

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