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.

Scientific evidence

Sequana Medical’s team is dedicated to ongoing clinical research.

We have invested significant resources in clinical studies in Europe to demonstrate the safety and efficacy of the alfapump® in liver refractory ascites patients. Key findings of these studies include:

  • an approximately 90% reduction in the mean number of LVPs per month for liver refractory patients treated with the alfapump versus patients treated with LVP standard of care;
  • a clinically significant improvement in patient quality of life for patients treated with the alfapump® versus patients treated with LVP standard of care;
  • liver refractory ascites patients treated with the alfapump® demonstrated a clear nutritional benefit versus patients treated with LVP standard of care over 30-day and 90-day periods.

The alfapump® was also effective in palliative patients with malignant ascites and demonstrated the potential to improve quality of life and clinical outcomes for late-stage cancer patients.

If you wish to carry out a clinical study involving the alfapump® system, please contact us

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