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.
We are a commercial stage medical device company developing the alfapump® platform for the treatment of fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective.
The alfapump®, is a fully implantable, programmable, wirelessly-charged, battery-powered system that is CE-marked for the treatment of refractory ascites due to liver cirrhosis and malignant ascites.
Over 900 alfapump® systems have been implanted. The alfapump® has been endorsed by key independent third parties in Europe and has received Breakthrough Device status from the US FDA.
We have leveraged our alfapump® technology experience and are developing alfapump DSR®, a novel and proprietary approach to the treatment of fluid overload in patients suffering from heart failure.
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