The alfapump® system is currently not 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. 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 United States or Canada.
Our alfapump® is one of the first medical devices designed to treat the build-up of fluid in the abdomen. It is a battery-powered pump that is implanted just under the skin for the controlled and continuous removal of fluid from the peritoneal cavity into the bladder where it is simply urinated away. The alfapump® system provides an automated system for the removal of fluid without the need for repeated needle punctures, needles or external tubes.
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 UK NICE interventional procedure guidance for the treatment of refractory ascites caused by cirrhosis.
In January 2019, the US FDA granted the alfapump® Breakthrough Device designation for the treatment of recurrent or refractory liver ascites. We submitted a Premarket Approval (PMA) application to the US FDA in December 2023 having reported positive primary and secondary endpoint data from the North American pivotal POSEIDON study of the alfapump® in recurrent or refractory ascites due to liver cirrhosis.
The alfapump® is implanted under the patient’s skin using minimally invasive surgery. It is a simple procedure taking approximately 60 minutes that can be performed under local anaesthesia with sedation.
In North America, we expect the procedure to be performed by interventional radiologists. Because the alfapump® is fully implanted, patients are able to retain normal mobility and activity. Once the alfapump® has been implanted, it is programmed wirelessly by the physician to ensure that the optimal amount of fluid is removed each day. The schedule can be designed to suit patients’ individual daily routine.
The only patient interaction is the need to recharge the battery each day with a wireless charger (the Smart Charger) through the skin for approximately 20 minutes (depending on the amount of fluid extracted each day). While charging, data from the alfapump® are transferred to the Smart Charger and transmitted wirelessly via the mobile phone network to secure servers using our proprietary DirectLink technology.
Using DirectLink technology, alfapump performance data are collected and transferred via the mobile phone network to secure servers for analysis – 24 hours a day, 7 days a week. Our data specialists receive pump performance information (e.g. volume pumped and pump charging) and report this information to clinicians enabling them to manage patients more effectively through closer monitoring and notification of changes in pump performance data.
We have invested significant resources in clinical studies in Europe and the US to demonstrate the safety and efficacy of the alfapump® patients with recurrent or refractory liver ascites.
The PMA application was submitted to the US FDA in December 2023 and was based on the successful execution of our pivotal POSEIDON study, a landmark study across 18 centers in the US and Canada with a total of 69 patients implanted with the alfapump®. The primary effectiveness endpoints at six months post-implantation in the Pivotal Cohort exceeded the predefined thresholds with statistical significance, and primary safety endpoint data was in line with expectations. Data at 12 months post-implantation continued to show a strong and durable clinical profile, virtually eliminating the need for therapeutic paracentesis and delivering a clinically meaningful improvement in patients’ quality of life.
Leading physicians talk about their experience with the alfapump®.