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

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 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 refractory liver ascites and malignant ascites. The alfapump® has been endorsed by key independent third parties in Europe and has been included in the EASL (European Association for the Study of the Liver) clinical practice guidelines for decompensated cirrhosis, the German treatment guidelines (DGVS) for complications of liver cirrhosis and the U.K. NICE interventional procedure guidance for the treatment of refractory ascites caused by cirrhosis.
In January 2019, the U.S. FDA granted the alfapump® Breakthrough Device designation for the treatment of recurrent or refractory liver ascites. A North American pivotal study (POSEIDON) is ongoing to support approval of the alfapump® in recurrent or refractory liver ascites in the U.S. and 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 to demonstrate the safety and efficacy of the alfapump® in patients with recurrent or refractory liver ascites and malignant ascites.

To support the approval of the alfapump® in North America, a pivotal POSEIDON study is ongoing. Interim results from 26 patients from the Roll-In Cohort demonstrated positive outcomes against all primary endpoints:

  • Over 90% reduction in mean frequency of therapeutic paracentesis versus baseline
  • All patients having at least 50% reduction in mean frequency of therapeutic paracentesis per month versus baseline
  • Clinically important improvement in quality of life maintained up to 12 months post-implantation
  • Safety profile in line with expectations – three patients experienced a composite primary safety event

More information can be found in the press release and the Webcast by Sequana Medical on 1 July 2021

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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