Sequana Medical NV has announced the submission of a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its alfapump system. The alfapump is designed for patients suffering from recurrent or refractory ascites due to liver cirrhosis. This submission marks a significant step toward potentially providing a novel treatment option for a challenging condition.
The alfapump is a fully implantable, wirelessly charged device intended to automatically and continuously remove ascites from the abdomen, directing it to the bladder for natural elimination through urination. The current standard of care often involves therapeutic paracentesis, a procedure that drains fluid from the abdomen using a large needle. If approved, the alfapump could become the first active implantable medical device available in the U.S. for this indication.
The PMA application is based on data from the pivotal POSEIDON study, conducted across 18 centers in the U.S. and Canada, involving 69 patients implanted with the alfapump. The study met its primary effectiveness endpoints at six months post-implantation, demonstrating a statistically significant reduction in the need for therapeutic paracentesis. Data at 12 months showed sustained clinical benefits, with a continued reduction in paracentesis procedures and improvements in patients' quality of life.
Key Findings from the POSEIDON Study
The POSEIDON study revealed a 100% median reduction in therapeutic paracentesis in the 4-6 month post-implant period compared to the three months prior to implantation. This effect was maintained during the 7-12 month post-implant period, indicating a sustained impact on ascites control. Furthermore, patients experienced clinically meaningful improvements in their quality of life, as measured by the physical component score of SF36 and the Ascites Q score.
Safety data from the POSEIDON study indicated a manageable safety profile. While some patients experienced device explants due to wound or skin erosion and discomfort, the rates of major adverse events and serious infections were within expected ranges. Importantly, renal function, as assessed by creatinine and eGFR levels, remained stable over the 12-month follow-up period. A matched cohort analysis comparing POSEIDON patients to those in the NACSELD registry suggested a safety profile comparable to standard paracentesis procedures.
Market Opportunity and Future Outlook
The North American market for recurrent and refractory ascites due to liver cirrhosis is substantial and growing, driven largely by the increasing prevalence of non-alcoholic steatohepatitis (NASH) / metabolic dysfunction-associated steatohepatitis (MASH). Sequana Medical estimates the market to reach 78,000 patients in 2025, expanding at an annual rate of 6-7% to over 170,000 patients by 2035. The company anticipates potential FDA approval in the second half of 2024 and plans to introduce the alfapump through a specialized sales force focused on U.S. liver transplant centers.
Ian Crosbie, Chief Executive Officer of Sequana Medical, stated, "This is a key milestone for the alfapump and underscores our commitment to improving treatment options for patients with recurrent or refractory liver ascites...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."
