The concept of the alfapump® dates back to 2000 when a physician was searching for a better way to manage his ascites patients.
The first prototypes were built in 2005 and the founders demonstrated the technical feasibility of the approach. The first patients were implanted with a device in 2008 and in 2011 we received the CE-mark for removal of refractory ascites due to liver cirrhosis following completion of the PIONEER clinical study. The alfapump® was commercially launched at the EASL meeting in 2012 and in the same year the CE-mark was received for removal of malignant ascites.
Since then we have continued to invest in the clinical, technical and commercial development of the alfapump®. This includes the completion of the MOSAIC IDE feasibility study in North America in patients with recurrent and refractory liver ascites and the publication of the results of the European randomised controlled trial and the initial results of the Post-Marketing Surveillance Registry in patients with refractory liver ascites.
Following these studies, 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 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.
In 2017, we established DSR (Direct Sodium Removal), a new breakthrough therapy in development for the treatment of volume overload in patients suffering from heart failure, in collaboration with Dr. Jeffrey Testani, Associate Professor at Yale University. Pre-clinical and clinical proof-of-concept of DSR was achieved and results of the first in human study were selected for the late-breaking presentation at the Heart Failure 2019 Congress.
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