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 utilizing our proprietary alfapump® and DSR (Direct Sodium Removal) technologies to develop innovative treatments for fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective.
The alfapump® is a unique, fully implanted, wireless device that automatically pumps fluid from the abdominal cavity into the bladder, where it is naturally eliminated through urination.
In the U.S., the alfapump® has received Breakthrough Device status from the FDA and the pivotal POSEIDON study is ongoing. In Europe, the alfapump® has received CE mark and over 850 devices have been implanted to date.
Direct Sodium Removal or DSR is managing sodium and fluid overload through use of a sodium-free infusate administered into the abdominal cavity.
Clinical studies in diuretic-resistent heart failure patients demonstrated that DSR therapy is able to manage the fluid balance, restore diuretic response and improve cardio-renal function.
Ascites has a dramatic impact on the quality of life of patients. Patients suffering from ascites are immobile and very restricted in their daily activities, and often report feelings of isolation and depression.
When we interviewed patients that had the alfapump® implanted, they all reported a substantial improvement in their daily life.
Through our ongoing development work and close collaboration with clinicians, we continue to grow the body of evidence for our alfapump® and DSR technologies, as shown by the multiple peer-reviewed journal publications.
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