The alfapump® system is not currently 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. For more information regarding the POSEIDON clinical study see www.poseidonstudy.com.
The 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.
The DSR therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR therapy and ongoing investigations with the alfapump® system in Europe.
The alfapump® is a subcutaneously implanted battery-operated pump, which automatically and continually moves ascites from the abdominal cavity to the bladder, where it is excreted naturally from the body for more quality of life.
Many patients have been able to resume some of the light activities they enjoyed before suffering from ascites, such as swimming or taking a short walk.