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.
Ascites is the accumulation of excess fluid in the abodomen, which is a key complication of liver cirrhosis (“liver ascites”) and is also caused by certain late-stage cancers (“malignant ascites”). Ascites has a dramatic negative impact on patient quality of life including difficulties eating, moving, breathing and sleeping.
In its early stages, ascites can usually be treated with medication (diuretics) and/or a salt-restricted diet.
However, these treatments sometimes become ineffective or are no longer tolerated by the body. In such cases the ascites is described as being ‘refractory’ to medical therapy and it is removed by paracentesis or sometimes by the placement of a shunt called TIPS . If above treatments are ineffective, liver transplantation may be required.