Disclaimer

The alfapump® system is currently not approved in Canada for commercial use. DSR® therapy is still in development and is currently not approved in the United States or Canada. Any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. Sequana Medical makes no claims of safety or effectiveness of the DSR® therapy in the U.S. or Canada. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe, the United States or Canada.

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The alfapump® system

The alfapump system for the automatic and continual removal of ascites

The alfapump® system was developed with the goal to develop an automated system to eliminate the need for repeated invasive procedures. Put simply, no needles, no external tubes, no repeated needle punctures.
The alfapump® is a subcutaneously implanted battery-powered pump that ensures the controlled and continual removal of ascites according to a programmed schedule set by the physician.

Fully implantable pump system

The alfapump® is implanted under the skin using minimally invasive surgery. This simple procedure usually takes between 30 and 60 minutes.
Once the alfapump® has been implanted, it is programmed by the physician to ensure that the optimal amount of ascites is removed each day and the schedule can be designed to suit each patient’s individual daily routine.

Wirelessly charged through the skin

The only patient interaction is the need to recharge the battery each day with a wireless charger (the smart charger) through the skin for approximately 20 minutes (depending on the amount of fluid extracted each day).
While charging, data from the alfapump® are transferred to this charger, which can be downloaded and evaluated by your doctor during hospital visits.

Direct Link Technology

With DirectLink Technology built into the alfapump® system, patients and physicians are offered an unprecedented level of comfort and convenience.
Via this DirectLink Technology, the alfapump® performance data are continuously collected via the mobile phone network and transferred to secure servers for analysis – coverage that is 24 hours a day, 7 days a week.

Components

The extensive research and development that went into the alfapump® is reflected in the sophisticated
workings of the pump mechanics and controls. The alfapump® is programmed, charged and monitored wirelessly. While you are reading or watching television, simply hold place the smart charger (the intelligent charging device) over the alfapump® to charge it.

alfapump®

The alfapump® is an automatic and programmable pump implanted under the skin and pumps up to 4 litres of ascites per full battery charge. It also monitors pressure in the bladder and abdominal cavity via pressure sensors to ensure optimal fluid management and contains anti-clogging control algorithms to prevent blockage.

Smart Charger

The smart charger is a hand-held charging device that enables charging of the alfapump® through the skin. While charging, data from the alfapump® are transferred to the smart charger. When placed on the docking station, these data are transmitted wirelessly via the mobile phone network to secure servers for analysis, using our Directlink Technology.

Catheters

Standard implantable grade silicone catheters are utilized to collect ascites from the abdominal cavity and deliver it to the bladder. These catheters are implanted completely inside the body and are not visible from the outside.
A surgical kit is provided to facilitate the implantation procedure as well as to customise the catheters to the patients’ anatomy.

alfapump® programmer

Physicians use the notebook and integrated software to download data from the alfapump® and to change settings. Unique FlowControl software enables quick and easy adaptation of patient-specific pumping programs.

Clinical Specialist Notebook Generation
Clinical specialist notebook

Clinical Specialists use the notebook and integrated software to download data from the alfapump® and to adapt settings.
The unique FlowTech Software configures, analyses, maintains and troubleshoots both implanted and non-implanted alfapump® devices, as well as any Smart Chargers.