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 alfapump® Multicentre, Post-Marketing Surveillance Registry in Alimentary Pharmacology & Therapeutics (AP&T).

Sequana Medical AG (Sequana Medical), a commercial stage medical device company and an innovator in the management of liver disease, announces the publication of “Treatment of refractory ascites with an automated low-flow ascites pump in patients with cirrhosis”, the results of the first 56 patients in the alfapump® multicentre Post-Marketing Surveillance Registry (PMSR) in AP&T (Alimentary Pharmacology & Therapeutics) (Publication details).

In the largest reported series to-date of patients implanted with the alfapump®, the continuous drainage of ascites with the alfapump® led to a significant reduction in paracentesis frequency, with the median frequency of paracentesis dropped over 90%, from 2.17 to 0.17 per month.

Fifty-six alfapump® patients (43 males, 13 women; mean age 62 years) with a contraindication to TIPSS (transjugular intrahepatic portosystemic shunt), from centres in Germany, Switzerland, UK and Spain were followed for up to 24 months. Complications, device deficiencies, paracentesis frequency and patient survival were recorded.

Dr. Guido Stirnimann of University Hospital Inselspital Bern, Switzerland, lead author of the manuscript, commented “The management of refractory ascites in patients with cirrhosis is challenging and novel therapies are an unmet need in Hepatology, due to the important limitations of both large volume paracentesis and TIPSS. The results of this largest reported series to-date of alfapump® patients, demonstrates that in real life subjects alfapump® provides an innovative and effective treatment option.”

“We are very pleased the results from the post-marketing surveillance registry has clearly demonstrated that the alfapump® delivers important benefits 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®. We are already seeing the impact of this in our more recent patient implants where we are seeing much lower rates of adverse events and reinterventions, and even greater reductions in paracentesis frequency.”

Download the full press release.

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