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. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe.
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) intended to support approval of the alfapump® in recurrent or refractory liver ascites in the U.S. and Canada, has reported positive top-line results, enabling us to file a Pre-Market Approval (PMA) application with the FDA, planned for H2 2023.
For more information on the alfapump® system, please visit our dedicated website
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.
To support the approval of the alfapump® in North America, a pivotal POSEIDON study is being conducted. Data from 40 patients implanted with the alfapump® in the Pivotal Cohort met all primary effectiveness endpoints of the study with statistical significance at six months post-implantation and primary safety endpoint data were in line with expectations.
More information can be found in the press release and the Webcast by Sequana Medical on 25 October 2022
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
Leading physicians talk about their experience with the alfapump®.
