Avenu Medical has received CE mark approval for the commercial sale of its Ellipsys vascular access system—a single catheter image-guided system.
Ellipsys is the first medical device to be approved for study under an Investigational Device Exemption (IDE) by the US Food and Drug Administration (FDA) for minimally invasive creation of arteriovenous fistulas.
News of Avenu receiving the CE mark also comes on the heels of the company reaching full patient enrolment in its FDA-authorised pivotal phase III IDE clinical trial. This multicentre study is designed to demonstrate the safety and efficacy for the percutaneous creation of arteriovenous fistulas.
“The procedure is simple and elegant. All the patients’ care from fistula creation through maturation is delivered in the office-based vascular centre,” says Jeffrey E Hull, director of the Richmond Vascular Center in Richmond, USA. “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.”