alfapump® for the management of fluid overload

Sequana Medical’s alfapump is a fully-implanted, programmable, wireless, CE-marked device that automatically and continuously pumps fluid from the peritoneal cavity into the bladder, where the body eliminates it naturally through urination. Sequana Medical is using the alfapump platform to bring new treatment options to patients with recurrent or refractory liver ascites and patients with fluid overload due to heart failure.
In Europe, the alfapump is CE-marked for the management of refractory ascites due to liver cirrhosis and malignant ascites. In the U.S., the alfapump has been granted breakthrough device designation by the FDA for recurrent and refractory liver ascites and a pivotal study is underway to support a future marketing application in the U.S. and Canada. Over 800 alfapump systems have been implanted to date and the potential of the alfapump to address the unmet medical need in patients with recurrent or refractory ascites has been demonstrated in multiple clinical studies showing a significant reduction in the need for large volume paracentesis and a significant improvement in patients’ quality of life.
Building on its proven alfapump platform, Sequana Medical is developing the alfapump DSR, a breakthrough, proprietary approach to fluid overload due to heart failure. Clinical studies are ongoing and a clinical proof-of-concept has been achieved.