Disclaimer
The alfapump® system is currently not approved in Canada for commercial use. DSR® therapy is still in development and is currently not approved in the United States or Canada. Any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. Sequana Medical makes no claims of safety or effectiveness of the DSR® therapy in the U.S. or Canada. 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).
Abstract | Poster par Wong et al., AASLD, 2017
Poster by Wong et al., AASLD, 2018
Solbach et al., European Journal of Gasteroenterology & Hepatology, 2018
Stirnimann et al., Alimentary Pharmacology & Therapeutics, 2017 (data on the first 56 patients)
Editorial by Macdonald and Jalan, Alimentary Pharmacology & Therapeutics, 2017
Bureau et al., Journal of Hepatology, 2017
Stepanova et al., Quality of Life Research, 2018
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.
Presentation by Dr. Testani at Heart Failure 2019
Webcast by Sequana Medical management and Dr. Testani on 27 May 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®.
Storni et al., The American Journal of Gastroenterology, 2018
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®.
Stirnimann et al., Therapeutics Advances in Gastroenterology, 2017
