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.
RETROSPECTIVE MALIGNANT ASCITES STUDY
Retrospective, multi-centre, open-label study in Europe to assess the performance and safety of the alfapump in 17 patients with malignant ascites (NCT03200106).
MOSAIC IDE FEASIBILITY STUDY
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).
HANNOVER STUDY
Retrospective, single-centre study at Hannover Medical School to investigate the alfapump as an alternative for LVP in 21 patients with liver refractory ascites with a contraindication for TIPS or liver transplant.
Solbach et al., European Journal of Gasteroenterology & Hepatology, 2018
PMSR
Prospective, multi-centre, open-label, observational study in Europe designed to follow 100 patients with liver refractory ascites with a contra-indication to TIPS and therefore treated with an alfapump for up to 24 months (NCT01532427).
Stirnimann et al., Liver International, 2022 (data from 106 patients)
Stirnimann et al., Alimentary Pharmacology & Therapeutics, 2017 (data from first 56 patients)
Editorial by Macdonald and Jalan, Alimentary Pharmacology & Therapeutics, 2017
RCT
Prospective, multi-centre, open-label, randomised and controlled study in Europe of the alfapump versus LVP standard of care in 58 patients with liver refractory ascites (NCT01528410).
Bureau et al., Journal of Hepatology, 2017
Stepanova et al., Quality of Life Research, 2018
PIONEER STUDY
Prospective, multi-centre, open-label, uncontrolled study in Europe to assess the safety and performance of the alfapump in 40 patients with liver refractory ascites and diuretic resistance (NCT01030185).
DSR PROOF OF CONCEPT STUDY
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.
