Avenu Medical is a well-established medical device company dedicated to creating a paradigm shift in vascular access for hemodialysis patients. Our focus is to pursue unmet clinical needs by developing a minimally invasive, cost effective and efficient approach to vascular access.
Founded in 2010 and headquartered in Orange County, California, we have developed the Ellipsys® Vascular Access System, an innovative, image-guided, single catheter system used to percutaneously create an arteriovenous (AV) fistula for hemodialysis access.
Over the past three years, the Ellipsys System has been used in clinical trials outside the United States. In December 2014, we received approval from the Food and Drug Administration (FDA) to begin a pivotal Phase III clinical trial in the United States through an Investigational Device Exemption (IDE). Patient enrollment for the trial was completed in June 2016 and the company has submitted the results in a market application to the FDA for future commercialization.
The Ellipsys System has received European CE Mark approval for the creation of an arteriovenous fistula in patients with chronic kidney disease requiring hemodialysis.