Sequana Medical announces first patient enrolled in North American alfapump® pivotal study (POSEIDON)
• Study aims to support the approval of the alfapump in U.S. and Canada
• Results anticipated by mid-2021
• U.S. launch of the alfapump planned for H1 2022
Ghent, Belgium: 25 September 2019 – Sequana Medical NV (Euronext Brussels: SEQUA), innovators in the management of fluid overload in liver disease, malignant ascites and heart failure, today announces that the first patient has been enrolled in the North American pivotal study (POSEIDON) of the alfapump for the treatment of recurrent and refractory ascites due to liver cirrhosis. The POSEIDON study intends to support marketing approval and reimbursement of the alfapump in the U.S. and Canada.
The POSEIDON study is a single-arm, open-label study and is expected to include up to 50 patients to be implanted with the alfapump in approximately 15 centres across the U.S. and Canada for primary endpoint analysis. The primary effectiveness outcome of the study will include the proportion of patients with a 50% reduction in overall average frequency of paracentesis per month post-implantation versus pre-implantation. This endpoint will be evaluated at nine months after enrolment. Patients will be followed for up to two years after implantation for analysis of secondary outcome measurements.
More info on Sequana’s website