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.

Liver ascites

Ascites is most commonly associated with advanced liver disease, and is due to the replacement of healthy liver tissue with fibrous or scar tissue, called cirrhosis, which may cause fluid to leak from the liver and accumulate in the abdominal cavity.

Alcohol and viral hepatitis B and C are common causes of cirrhosis, although there are many other causes including non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatis (NASH). NASH is a “silent disease”, which means it is difficult to diagnose until the disease is significantly developed and therefore intervention at an early stage to prevent the fibrosis and scarring is clinically challenging. The incidence of liver disease and liver cirrhosis is increasing driven by unhealthy lifestyles, obesity and ageing populations.

Liver ascites forms as the result of a sequence of events which are usually asymptomatic. Following the development of scar tissue within the liver, portal hypertension is likely occur. As portal hypertension develops, various biological factors will tend to over come the apparition of portal hypertension with the release locally of vasodilators. A chain of cascades will follow affecting the splanchnic blood flow and arterial pressures, which will results activation of different other mechanisms and resulting in sodium and water retention.

Approximately 50% of cirrhotic patients develop ascites within 10 years of the diagnosis of cirrhosis