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® system is intended for single patient use only and for a period of up to 2 years in patients with refractory ascites due to liver cirrhosis or malignant ascites with a life expectancy of 6 months or less. Patients must be 18 years or older and may not be pregnant.
Clinicians and surgeons must be trained by Sequana Medical staff on how to implant and program the alfapump® as well as on how to train the patient to use the Smart Charger.
The patient must be able to read the Smart Charger Instructions for Use and must be trained by a clinician on how the Smart Charger is used to charge their alfapump®.
Surgical implantation of the alfapump® system should be postponed if there is an infection in the peritoneal cavity.
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.
Hyperbaric oxygen therapy is contraindicated because the environmental conditions entailed in this therapy are out of the defined range of use for the alfapump® system.
Supersonic and high-frequency heat therapies should not be used on patients with the alfapump® system due to possible heating effects of the implanted alfapump®. If the therapy must be performed, it should not be applied in the immediate vicinity of the alfapump system or the surrounding areas. The alfapump system should be continuously monitored during the treatment and system function must be checked after the therapy.
TENS therapy should not be used on patients with the alfapump® system. If the therapy must be used, the TENS electrodes should be placed as close as possible to each other to reduce the spread of electricity, and as far away as possible from the alfapump®. After stimulation, alfapump® system function must be checked.
The circuitry of the alfapump® is protected against the energies normally induced by defibrillation. Nevertheless, complete protection is not possible. The implanted alfapump® can be damaged by defibrillation. Circumstances permitting the energy setting should not be higher than necessary for defibrillation and the distance between the paddles and the alfapump® should be at least 10 cm. After defibrillation, alfapump® system function must be checked.
The electronic circuit elements of the alfapump® can be damaged by radiation therapy. The alfapump® should be shielded during the therapy. Following the radiation treatment, the alfapump® system function must be checked.
Electrocautery should not be performed within 15 cm of an implanted alfapump® because it could damage the pump circuitry. For trans-urethral electro-resection of the prostate, it is recommended to place the neutral electrode on the buttocks or upper thigh, but not in the thoracic area. The alfapump® system function must be checked and monitored after the procedure.
Before applying any of the aforementioned procedures please contact Sequana Medical’s customer service or your local sales representative.
Pacemakers, implantable defibrillators and other active implants are not contraindicated but must be verified for proper functioning after implantation of the alfapump® system.
Please refer to intended use provided with the alfapump® system. If you wish to receive a copy, please contact your Sequana Medical representative or contact us at info@sequanamedical.com
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.
