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.

Malignant ascites

Malignant ascites is ascites which is caused by certain types of advanced cancer, including ovarian, breast, pancreatic, lung, liver, colon/rectum and lymphoma cancer, due to fluid build-up in the peritoneal cavity from a number of causes including draining of the lymph system.

The use of diuretics and a salt-restricted diet is rarely effective in the treatment of malignant ascites. The use of chemotherapy drugs delivered directly into the abdominal cavity may stop the accumulation of ascites, but this relief is temporary and the ascites inevitably reappears. Patients may require repeat paracentesis for symptomatic relief.

While life expectancy for many cancer patients with malignant ascites is short (less than 3 months), ovarian and breast cancer patients often have longer life expectancies.