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.
Sequana Medical has leveraged its alfapump® experience and is developing alfapump® DSR, a fully implanted system for DSR therapy in patients with volume overload due to heart failure.
alfapump® DSR combines three proven elements:
The sodium-free infusate is administered to the peritoneal cavity via the surgically implanted port, which allows for flexible dosing to remove the desired amount of sodium. The DSR infusate remains there for a pre-determined period of time before the DSR infusate and the extracted sodium is pumped to the bladder and eliminated through urination.
A repeated dose alfapump® DSR study, combining DSR therapy with our proven alfapump® platform, began in H2 2019.
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