Avenu Medical has secured CE mark approval for its Ellipsys vascular access system to market in the European countries.
Ellipsys is a single catheter image-guided system designed to meet the requirements of vascular access for hemodialysis.
It has also completed patient enrollment in its FDA-authorized pivotal phase III IDE clinical trial, which is designed to show the safety and efficacy for the percutaneous creation of AV fistulas.
Avenu Medical president Mark Ritchart said: "This is a major milestone both for our company and for the patients and physicians within the End Stage Renal Disease (ESRD) communities.
"In the United States and around the world, there is a shortage of dedicated vascular access surgeons who can create AV fistulas.
"Our Ellipsys System has the potential to increase the number of clinicians performing vascular access procedures which may improve patient care by reducing time from request for fistula to usable access for dialysis."
The approval allows the firm to launch the technology at clinical centers of excellence across Europe.
The Ellipsys sysem, which is not yet approved in the US, is limited by federal law to investigational use. The company plans to file for FDA market authorization for Ellipsys later this year.