Sequana Medical NV (Euronext Brussels: SEQUA) has announced that the U.S. Food and Drug Administration (FDA) has granted unconditional Investigational Device Exemption (IDE) approval for the POSEIDON study. This pivotal trial will evaluate the alfapump system in patients suffering from recurrent or refractory ascites due to liver cirrhosis, with the goal of securing approval and reimbursement in the U.S. and Canada.
POSEIDON Study Design
The POSEIDON study is designed as a single-arm, open-label, within-subject crossover trial. It will enroll up to 50 patients with recurrent or refractory ascites due to liver cirrhosis across multiple centers in the U.S. and Canada. An additional training cohort of up to 30 patients may be enrolled to ensure centers gain experience with the alfapump prior to the study cohort. The study includes a 3-month pre-implant observation period, a 3-month stabilization period post-implantation, and a 3-month post-implant observation period.
Primary and Secondary Endpoints
The primary effectiveness outcome is the proportion of patients achieving a 50% reduction in the average frequency of therapeutic paracentesis per month during the post-implant observation period (months 3-6) compared to the pre-implant observation period. The per-patient ratio of post-implant to pre-implant average monthly therapeutic paracentesis will also be assessed. The primary safety endpoint is the rate of alfapump-related re-interventions, as adjudicated by a Clinical Events Committee. Secondary outcomes include safety (device and/or procedure-related adverse events), quality of life (SF-36 and Ascites-Q questionnaires), nutritional status, health economics, and overall survival, with a follow-up period of up to two years.
The alfapump System
The alfapump is a fully implanted, programmable, wireless device designed to automatically pump ascites from the peritoneal cavity into the bladder, where it is naturally eliminated through urination. It is CE-marked in Europe for managing refractory ascites due to liver cirrhosis and malignant ascites due to cancer. Clinical studies have demonstrated that the alfapump significantly reduces the need for large volume paracentesis (≥5 liters) and improves patients' quality of life.
Clinical Context and Unmet Need
Ascites, a common complication of liver cirrhosis, involves the accumulation of fluid in the abdomen. Patients may accumulate 10-15 liters of ascitic fluid every 15 days. Recurrent or refractory ascites severely impacts quality of life, causing pain, breathing difficulties, mobility issues, and gastrointestinal distress. Current treatment options have limitations, including significant side effects and short-term relief. The prevalence of refractory liver ascites is expected to increase due to the rise of Non-Alcoholic Steatohepatitis (NASH).
Management Perspective
Ian Crosbie, CEO of Sequana Medical, stated, "We are delighted with the IDE approval and optimised clinical trial design for POSEIDON and are grateful for the close collaboration with the FDA. As a result, and together with the Breakthrough Device Designation granted in January this year, we have brought forward our plans for U.S. launch of the alfapump to H1 2022".
Gijs Klarenbeek, CMO of Sequana Medical, added, "The FDA has provided us with invaluable advice on the design of the POSEIDON study. The final study design allows for a reduced number of study patients to be enrolled and a shorter follow-up time for primary endpoint analysis."
