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.
[2] Quality of life as defined by subjective physical health (assessed by SF-36 PCS) and ascites symptoms (assessed by Ascites Q)
[1] POSEIDON study results in SSED (PMA P230044, FDA approval letter on file) – 100% median reduction in number of therapeutic paracentesis per month in Pivotal Cohort
Estes et al. (2018)
Ginès et al. (2004) (déclarant que l’ascite réfractaire apparaît chez 5 à 10% des patients souffrant d’ascite)
Testani JM, Hanberg JS, Cheng S, et al. Rapid and Highly Accurate Prediction of Poor Loop Diuretic Natriuretic Response in Patients With Heart Failure. Circulation Heart failure. 2016;9(1):e002370. doi:10.1161/CIRCHEARTFAILURE.115.002370
Kilgore et al. (2017); Ambrosy et al. (2014)
Kilgore et al. (2017)
Costanzo et al. (2007)
Benjamin et al. (2013)
Ayantunde et al. (2006)
World Health Organization International Agency for Research on Cancer 2018 (website) (estimated number of new breast and ovarian cases in 2018 (crude rate))
European Association for the Study of the Liver. EASL clinical practice guideliones on the management of ascites, spontane bacterial peritonitis, and hepatorenal syndrome in cirrhosis. Journel of Hepatology. 2010 vol. 53. 397-417. p. 402
Runyon et al. (2009)
GlobalData NASH Epidemiology Forecast to 2026
U.S. Centers for Disease Control and Prevention, Health, United States 2016, Chartbook on Long-term trends in Health, Table 20 (web site)
United States
Stay on sequanamedical.com
Europe
Go to alfapump.com