The alfapump® system is currently not approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe, the United States or 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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