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.
We have received CE Mark approval for the alfapump®, for the treatment of liver refractory ascites and malignant ascites, and have built a strong body of evidence demonstrating the safety, efficacy and quality of life benefits in over 800 implants and multiple clinical studies.
We are also developing the alfapump DSR®, a convenient and fully implanted system for direct sodium removal (DSR®), our proprietary therapy for the management of volume overload due to heart failure.
The alfapump® is a fully-implantable, wirelessly-charged, CE-marked system that automatically and continuously pumps ascites from the abdominal cavity into the bladder, where the body eliminates the ascites naturally. The alfapump® system’s DirectLink Technology allows physicians to receive pump performance information and more effectively manage their patients.
The alfapump® has been endorsed by key independent authorities in Europe and has received Breakthrough Device status from the U.S. FDA.
Direct Sodium Removal (DSR®) is our proprietary therapy for the management of volume overload in patients suffering from heart failure. This breakthrough approach involves removing sodium from the body using diffusion via the peritoneal cavity with the use of a sodium-free solution. Once the sodium has been removed, the body eliminates excess fluid via urination and osmotic ultrafiltration, resulting in a sustained fluid reduction. We have leveraged our alfapump® technology experience and are developing the alfapump DSR®, a convenient and fully implanted system for DSR® therapy.
Ascites has a dramatic impact on the quality of life of those affected patients. Patients suffering from ascites report feelings of isolation and depression related to their immobility and limitations in their daily activities.
When we interviewed patients that had the alfapump® implanted, they all reported a significant 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® platform, as shown by the multiple peer-reviewed journal publications.
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