Sequana Medical Announces Positive Outcomes from North American Pivotal Alfapump Study (POSEIDON)
Data presented at EASL Congress 2023
The alfapump demonstrated effectiveness in controlling ascites, virtually eliminating the need for needle paracentesis. The safety profile was in line with expectations, with six primary safety events reported. Patients experienced a clinically meaningful and statistically significant improvement in quality of life, and a one-year survival rate of 70% was observed, which compares favorably to existing literature.
Professor Florence Wong, Principal Investigator for the POSEIDON study, highlighted the alfapump's impact on reducing the need for large volume paracentesis and improving patients' quality of life. Ian Crosbie, CEO of Sequana Medical, emphasized the device's potential as a breakthrough treatment for recurrent or refractory liver ascites patients, noting the growing prevalence of NASH as a key driver of liver cirrhosis.
Key findings from the POSEIDON study include:
- 100% median per-patient reduction in therapeutic paracentesis (TP) post-implantation compared to pre-implantation.
- 77% of patients achieved at least a 50% reduction in the number of TP.
- Six primary safety events were reported, with three explants due to wound or skin erosion and three due to patient-reported discomfort.
- Major Adverse Events (MAE) and serious infections post-implantation were comparable to pre-implantation levels.
- Acute Kidney Injuries (AKI) were mostly stage 1, with stable renal function observed over long-term follow-up.
- Significant improvements in quality of life were reported, with both the physical component score of SF36 and the Ascites Q score showing statistically significant improvements.
Survival outcomes indicated a positive trend, with a Kaplan-Meier estimate of 70% survival probability at one year post-implantation, surpassing the literature-reported survival rate for refractory ascites patients.
The POSEIDON study's findings underscore the alfapump's potential as an effective treatment for recurrent or refractory ascites due to liver cirrhosis, offering hope for improved patient outcomes and quality of life. The data will be submitted for publication in a peer-reviewed journal in 2023, further contributing to the body of evidence supporting the alfapump's clinical benefits.