Avenu Medical’s Ellipsys Vascular Access System Approved in Europe
June 9, 2016—Avenu Medical, Inc. announced last week that it has received European CE Mark approval for the commercial sale of its single-catheter, image-guided Ellipsys vascular access system for hemodialysis.
The company also completed patient enrollment for the pivotal phase 3 clinical trial of the device in the United States. The US Food and Drug Administration (FDA) approved an investigational device exemption to study the Ellipsys. The multicenter study is designed to demonstrate the safety and efficacy for the percutaneous creation of arteriovenous fistulas. Avenu intends to file for FDA market authorization later this year. Currently, the Ellipsys vascular access system is an investigational device and is limited by federal law to investigational use and is not for sale in the United States, advised Avenu Medical.
Commenting in the announcement on treatment with the Ellipsys device, Jeffrey E. Hull, MD, stated, “The procedure is simple and elegant. All the patients’ care from fistula creation through maturation is delivered in the office-based vascular center. Using the Ellipsys vascular access system is very similar to common procedures such as obtaining venous and arterial access with ultrasound. This new, minimally invasive procedure requires similar skills. Most physicians involved in vascular access have these skills and will learn to use the Ellipsys system quickly.” Dr. Hull is Director of the Richmond Vascular Center in Richmond, Virginia.