Sequana Medical AG (Sequana Medical), a commercial stage medical device company and an innovator in the management of liver disease, today announced that Prof. Florence Wong, University of Toronto, presented the findings of the MOSAIC study data at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) Annual Meeting (The Liver Meeting®), held in Washington, DC.
This North American prospective, open label, single arm, multi-centre study comprised 30 cirrhotic patients with recurrent large ascites, and not eligible for TIPS. Lead investigators of the study, Professor Florence Wong from University of Toronto, Toronto, ON, Canada and Professor Patrick Kamath from Mayo Clinic College of Medicine and Science, Rochester, MN concluded: “alfapump implantation resulted in a clinically significant improvement in mean quality of life, as measured by CLDQ and AscitesQ (two validated questionnaires), and elimination of LVP requirement in 70% of patients at 3 months. Study patients had greater than expected overall survival compared with prior publications. Reinterventions, explants and adverse events related to AKI and infection remain as concerns. Further studies should include revised catheter design and procedural and post-procedure care algorithms.”
Ian Crosbie, Chief Executive Officer of Sequana Medical added, “We are very pleased to see that in the MOSAIC study the alfapump® delivers clear benefits to this important patient group in terms of quality of life improvement and dramatic reduction in the burden of large volume paracenteses. In addition, the increased survival of these patients compared to what is expected in a population of patients with refractory ascites is very exciting. The growth of NAFLD and NASH makes the need for an innovative and effective treatment option for refractory ascites all the more important. Through our ongoing development work and close collaboration with clinicians, we continue to further improve the performance of the alfapump®, resulting in lower rates of adverse events, and even greater reductions in paracentesis frequency in our more recent patient implants.”