Sequana Medical NV, a leader in treating fluid overload in liver disease, heart failure, and cancer, has revealed compelling data from its North American pivotal POSEIDON study on the alfapump® system. The study demonstrates a significant improvement in the quality of life for patients suffering from recurrent or refractory ascites due to liver cirrhosis, compared to baseline measurements. This improvement was not observed in a contemporaneously enrolled cohort from the NACSELD3 study, which focused on refractory ascites patients.
Key Findings:
- Quality of Life Improvement: Patients in the alfapump cohort experienced significant enhancements in quality of life, particularly in ascites symptoms and physical functions, as evaluated by Ascites-Q and SF-36 (Physical Component Score) at six months post-implantation.
- Safety Outcomes: The safety profile of the alfapump was found to be comparable to standard care, with no statistically significant differences in mortality, hospitalizations, or liver transplants between the alfapump and NACSELD3 cohorts.
- Patient Preference: A matched cohort analysis indicated a strong preference among US patients for the alfapump over standard paracentesis procedures.
Dr. Bajaj, Professor of Medicine at Virginia Commonwealth University, emphasized the potential of the alfapump to address the unmet needs of patients with cirrhosis and recurrent or refractory ascites. Dr. Gijs Klarenbeek, Chief Medical Officer at Sequana Medical, highlighted the consistent evidence supporting the alfapump's impact on improving patients' quality of life.
The alfapump system, which automatically and continuously removes ascites from the abdomen into the bladder for natural elimination, represents a significant advancement over the current standard treatment of therapeutic paracentesis. With the US market approval anticipated before the end of Q1 2025 and a commercial launch planned for H2 2025, the alfapump could offer a modern and impactful care option for patients severely affected by this condition.
This groundbreaking data will be presented at the EASL Congress 2024, Europe's largest event in the field, taking place in Milan, Italy, marking a pivotal moment in the treatment of fluid overload in liver disease.
