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.
Ascites has a dramatic impact on the quality of life of affected patients. Patients suffering from ascites report feelings of isolation and depression because of their immobility and limitations in their daily activities. It also entails a huge burden for their family members because of the frequent hospital visits for paracentesis and the feeling of being housebound and constant worrying when not around.
Patients with liver refractory ascites that had the alfapump implanted experienced a significant improvement in their daily life as demonstrated in the various clinical studies and through extensive commercial experience. When Sequana Medical interviewed patients that had been implanted with the alfapump, they all indicated how it changed their lives in a positive way, by feeling better and being mobile and self-caring again.
Patients reported that they were eating, breathing and sleeping better; able to cook for their family again, go on vacation without worrying about getting back in time for the paracentesis; feeling strong enough to do anything they wanted to do. Also their family members experienced a big change and were able to enjoy life together again.
67 year old patient tells us how his life changed after an alfapump® implantation.
Wife of an alfapump® patient talks about changes on her live.
21-year-old patient reports on recovered quality of life with the alfapump® system.
70-year-old patient talks about his recovered independence with the alfapump® system.
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