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.

Refractory Ascites

Refractory ascites is ascites that cannot be mobilized by low sodium diet and diuretic treatment or recurs shortly after medical therapy.

Patients may accumulate as much as 10-15 litres of fluid within the abdomen every 15 days.

When large quantities of ascites accumulate in the abdominal cavity, the sheer volume of liquid puts pressure on the surrounding organs such as the bladder, stomach and even diaphragm. In addition to making it difficult to move around, common symptoms include fatigue, shortness of breath and some pain. Pressure on the stomach can lead to loss of appetite and heartburn, ultimately resulting in malnutrition, and constant shortness of breath can limit a patient’s capacity to perform even minor everyday tasks. Too much pressure inside the abdomen can lead to the development of hernias around the belly button or in the groin. Patients with ascites are also at high risk of other complications, such as severe internal infections and kidney problems.

With the alfapump®, we provide an automatic system to remove ascites from the body on a continual basis, thereby reducing or eliminating the occurrence of these unpleasant and harmful complications.