1-channel infusion pump ALFAPUMP®

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.