Sequana Medical NV, a leader in treating diuretic-resistant fluid overload in liver disease, malignant ascites, and heart failure, has announced the completion of alfapump implantations in the POSEIDON study. This North American pivotal study supports the regulatory approval of the alfapump system for treating recurrent or refractory ascites due to liver cirrhosis.
- Study Details: Of the 71 patients enrolled, 40 have been implanted with the alfapump in the Pivotal Cohort, with data reporting planned for Q4 2022. An additional 29 patients from the Roll-In Cohort were also implanted, contributing to the overall safety analysis.
- Preliminary Results: A preliminary interim analysis showed a mean survival probability of 70% at 12 months post-implantation for the Roll-In Cohort, significantly higher than the 50% survival rate reported in published literature for refractory ascites patients.
- Leadership Commentary: Ian Crosbie, CEO of Sequana Medical, highlighted the importance of this milestone amidst ongoing COVID-related hospital resource uncertainties. Dr. Gijs Klarenbeek, Senior Medical Adviser, expressed optimism about the alfapump's potential as a treatment option, citing improved quality of life and reduced therapeutic paracentesis rates in patients.
The POSEIDON study's progress and preliminary findings underscore the alfapump system's potential to offer a new treatment avenue for patients with recurrent or refractory ascites due to liver cirrhosis, marking a significant step forward in addressing this high-risk patient population's needs.