The alfapump® system is currently not approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe, the United States or Canada.
This is a prospective, multi-centre, open-label, randomised, health-economic study in France to evaluate the cost utility of the alfapump® versus standard of care in 90 patients with liver refractory ascites, 60 patients not waiting for liver transplant and 30 patients as bridge to transplant, over 12 months. The goal of the study is to support French reimbursement. The study is funded by the French government and being conducted and sponsored by leading French clinicians (NCT03506893).
Retrospective, multi-centre, open-label study in Europe to assess the performance and safety of the alfapump® in 17 patients with malignant ascites (NCT03200106).
Prospective, multi-centre, open-label, single-arm study in North America to assess the safety and efficacy of the alfapump® in 30 patients with liver recurrent or refractory ascites not eligible for TIPS (NCT02400164).
First-in-human single dose DSR proof of concept study to assess safety, tolerability and impact of direct sodium removal therapy in 10 patients receiving peritoneal dialysis (PD). Results selected for late-breaking abstract session at Heart Failure 2019.
Single dose, single arm preclinical proof of concept study to assess impact of direct sodium removal therapy in 15 healthy pigs and 5 pigs with experimentally induced heart failure via tamponade.
Poster by Testani et al., HFSA, 2018
Case study of treatment of a patient with malignant ascites using the alfapump®.
Review of the available data about patient selection, efficacy and safety of the alfapump® and recommendations for the management of patients treated with the alfapump®.