Disclaimer
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.
In den USA und Kanada befindet sich der alfapump® derzeit noch in der klinischen Erprobung. Daher sind Aussagen zur Sicherheit und Wirksamkeit in diesen Gebieten nicht anwendbar.
Die DSR-Therapie befindet sich noch in der Entwicklung, und es sollte beachtet werden, dass Aussagen zur Sicherheit und Wirksamkeit aus laufenden vorklinischen und klinischen Untersuchungen stammen, die noch nicht abgeschlossen sind.
Es besteht kein Zusammenhang zwischen der DSR-Therapie und laufenden Untersuchungen mit dem alfapump®-System in Europa, den USA und Kanada.
The alfapump® is still under clinical investigation in the US and Canada and therefore any statements regarding safety and efficacy do not apply in these territories.
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.
There is no link between the DSR therapy and ongoing investigations with the alfapump® system in Europe, the US and Canada.