Recurrent and refractory ascites is a key complication of liver cirrhosis, characterized by the accumulation of fluid in the abdomen. These patients can have up to 15 liters of extra fluid in their bodies, causing many health issues and severely impacting their daily lives. Although diuretics are the standard of care, the problem is that in many patients they are no longer effective and/or tolerable, requiring patients to undergo regular paracentesis. Paracentesis is a painful and burdensome procedure that drains ascites from the abdomen using a large needle over an extended period, with only short-term benefits for the patients, requiring frequent hospitalizations and severely impacting their quality of life. Now, a fully implantable, wirelessly charged device for patients with recurrent or refractory ascites due to liver cirrhosis could transform the lives of these patients by virtually eliminating the need for paracentesis and delivering clinically important improvements in quality of life.

Sequana Medical’s (Ghent, Belgium) alfapump automatically and continuously removes ascites from the abdomen into the bladder, where it is naturally eliminated through urination. Sequana has submitted a Premarket Approval (PMA) application to the US Food and Drug Administration (FDA) for alfapump which could become the first active implantable medical device in the US for treating liver ascites upon approval. The PMA filing is based on the successful execution of Sequana’s pivotal POSEIDON study, a landmark study across 18 centers in the US and Canada with a total of 69 patients implanted with the alfapump. The primary effectiveness endpoints at six months post-implantation in the Pivotal Cohorti exceeded the predefined thresholds with statistical significance, and primary safety endpoint data was in line with expectations.

Data at 12 months post-implantation continued to show a strong and durable clinical profile, virtually eliminating the need for therapeutic paracentesis and delivering a clinically meaningful improvement in patients’ quality of life. Data from the patient preference study and a matched cohort analysis of the NACSELDiv registry with the POSEIDON Pivotal Cohort indicated that US patients have a strong preference for the alfapump vs. standard paracentesis procedures and that the safety profile of the alfapump is comparable to standard of care.

“The submission of our Premarket Approval application to the FDA is the result of an enormous team effort and a clear demonstration of our intensive preparation to fulfil US regulatory requirements,” said Timur Resch, Global Vice President QM/QA/RA at Sequana Medical. “We have great confidence in the strength of our PMA submission and look forward to work in close collaboration with the FDA to facilitate a seamless and thorough review process intended to bring our breakthrough device to the US market as soon as possible.”

“This is a key milestone for the alfapump and underscores our commitment to improving treatment options for patients with recurrent or refractory liver ascites,” said Ian Crosbie, Chief Executive Officer of Sequana Medical. “This overlooked patient group is forecast to grow strongly due to NASH / MASH and today’s limited treatment options often lead to poor clinical outcomes, severely reduced quality of life, a substantial burden on their caregivers and high costs to payors. Data from our North American pivotal study demonstrate the potential for alfapump to transform the lives of these patients by virtually eliminating the need for paracentesis and delivering clinicially important improvements in quality of life. We anticipate FDA approval in the second half of 2024 and look forward to introducing the alfapump through our own specially sales force focused on US liver transplant centers.” 

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