FDA Approves Expansion of Patient Enrolment in Sequana Medical's POSEIDON Study for Alfapump Treatment
Sequana Medical NV, a leader in treating diuretic-resistant fluid overload in liver disease, malignant ascites, and heart failure, announced FDA approval to increase patient enrolment in the POSEIDON study to 70 patients, up from the initial target. This adjustment addresses the higher-than-expected attrition rate between study enrolment and alfapump implantation, aiming to ensure 50 patients receive the alfapump.
Key Details:
- Current Enrolment: 59 patients have been enrolled in the Pivotal Cohort.
- Expected Completion: Patient enrolment is anticipated to conclude by the end of the year, with primary endpoint results expected in Q4 2022.
- Study Design: POSEIDON is a single-arm, open-label, within-subject cross-over study conducted across approximately 20 centres in the U.S. and Canada. It includes a Pivotal Cohort for primary endpoint analysis and a Roll-In Cohort to ensure centres are experienced with alfapump implantation.
Interim Results: The second interim analysis of the POSEIDON study, reported in July 2021, showed positive outcomes, including a significant reduction in the frequency of therapeutic paracentesis and improvements in patients' quality of life.
About the Alfapump: The alfapump is a fully implanted, wireless device that automatically removes excess fluid from the abdominal cavity, offering a novel treatment for patients with recurrent or refractory ascites due to liver cirrhosis. It has been granted breakthrough device designation by the FDA.
Future Steps: Sequana Medical is diligently working towards completing the POSEIDON study, with the aim of submitting a marketing application for the alfapump in the U.S. and Canada by mid-2023. The company remains committed to advancing treatment options for patients suffering from fluid overload conditions.