The alfapump® system

Important Regulatory Disclaimers

The alfapump® system is a fully implantable pump system that collects ascites as it forms and moves it into the bladder, where it is passed naturally from the body through normal urination. The implantation procedure can be performed under local or general anaesthesia in less than one hour.

Once implanted, patient interaction with the alfapump® system is minimal. The patient simply charges the alfapump® wirelessly through the skin by holding a hand-held charging device over the alfapump®. While charging, data from the alfapump® is transferred to this charger. This data can be accessed by the physician during follow-up visits and settings can be changed as appropriate.

The alfapump® has received CE Mark approval for liver refractory ascites and malignant ascites. Since April 2018, the alfapump® has been included in the EASL clinical practice guidelines for the management of patients with decompensated cirrhosis. The alfapump® has not yet received regulatory approval in the U.S. and in Canada.

 

For more information on the alfapump® system, please visit our dedicated website

A breakthrough system for the automatic and continual removal of ascites

The alfapump® system was developed with the goal 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 doctor. The only patient interaction is the need to recharge the battery each day with a wireless charger through the skin for approximately 20 minutes (depending on the amount of fluid extracted each day).

Just one short operation is needed to implant the alfapump® system under the skin.
Once the alfapump® has been implanted it is programmed by the patient’s doctor 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. The alfapump® has a special mechanism which that ensures ascites is only moved into the bladder if there is space and it will turn itself off if there is no ascites in the abdominal cavity, ensuring optimal fluid management with no inconvenience for the patient.

We have invested significant resources in clinical studies in Europe to demonstrate the safety and efficacy of the alfapump® in liver refractory ascites patients. Key findings of these studies include:

  • an approximately 90% reduction in the mean number of LVPs per month for liver refractory patients treated with the alfapump® versus patients treated with LVP standard of care
  • a clinically significant improvement in patient quality of life for patients treated with the alfapump® versus patients treated with LVP standard of care
  • liver refractory ascites patients treated with the alfapump® demonstrated a clear nutritional benefit versus patients treated with LVP standard of care over 30-day and 90-day periods

The alfapump® was also effective in palliative patients with malignant ascites and demonstrated the potential to improve quality of life and clinical outcomes for late-stage cancer patients.

DirectLink Technology - 24/7 coverage

With DirectLink Technology built into the alfapump® system, patients and physicians are offered an unprecedented level of comfort and convenience as 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.

 

For more information on the alfapump® system, please visit our dedicated website

Physician interviews

Leading physicians talk about their experience with the alfapump®.

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