Sequana Medical announces positive top-line results from ...
The alfapump, a device for treating recurrent or refractory ascites due to liver cirrhosis, met primary effectiveness endpoints with 100% median reduction in therapeutic paracentesis and 77% of patients achieving at least 50% reduction. Safety data aligned with expectations, supporting a planned FDA PMA application in H2 2023. Over 60,000 North American patients could benefit, with numbers expected to grow.
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The alfapump, a device for treating recurrent or refractory ascites due to liver cirrhosis, met primary effectiveness endpoints with 100% median reduction in therapeutic paracentesis and 77% of patients achieving at least 50% reduction. Safety data aligned with expectations, supporting a planned FDA PMA application in H2 2023. Over 60,000 North American patients could benefit, with numbers expected to grow.