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.
The alfapump is not known to cause any other implanted device to fail. As a measure of precaution, we strongly recommend that you do not place your Smart Charger over any other implanted device while charging.
This diagnostic procedure is contraindicated due to possible movement of the alfapump, damage to the pump circuitry, tissue damage in the vicinity of the alfapump and/or catheter dislocation.
Please note that the above information do not replace the information given in the instruction for use. Please refer to the information for use received with your Smart Charger for further information or contact your physician.
Please note that the above information do not replace the information given in the instruction for use. Please refer to the information for use or contact your physician.