Disclaimer
The alfapump® system is currently not approved in Canada for commercial use. DSR® therapy is still in development and is currently not approved in the United States or Canada. Any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. Sequana Medical makes no claims of safety or effectiveness of the DSR® therapy in the U.S. or Canada. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe, the United States or Canada.
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.
The alfapump® has received CE mark in Europe. In the US, the alfapump® has received Breakthrough Device status from the FDA in December 2019. Over 1000 devices have been implanted to date.
In December 2024 alfapump® received U.S. FDA Approval and is the first U.S. approved active implantable medical device for the treatment of recurrent or refractory ascites due to liver cirrhosis.
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.
