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.

Relevant information

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®.

Note
The alfapump® must be used together with Sequana Medical’s Smart Charger and FlowControl software in order to control the alfapump® and provide optimal therapy for the patient. Please refer to the Smart Charger Instructions for Use and alfapump® Programmer Instructions for Use for their respective directions
Risks with Implanting the alfapump® System
Peritoneal cavity infections / Peritonitis

Surgical implantation of the alfapump® system should be postponed if there is an infection in the peritoneal cavity.

Medical Therapy Hazards
Magnetic Resonance Imaging (MRI)

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

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 therapy and high-frequency heat therapy

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.

Transcutaneous Electrical Nerve Stimulation (TENS)

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.

Defibrillation

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.

Radiation therapy

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

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

We would like to use cookies to better understand your use of this website. This enables us to improve your future experience on our website. Detailed information about the use of cookies on this website and how you can manage or withdraw your consent at any time can be found in our Privacy & Cookie Policy

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close