Avenu Medical Receives CE Approval for the Vascular Access System

 

Avenu Medical, Inc. announced today that it has received CE Mark approval for the commercial sale of its Ellipsys® Vascular Access System, an innovative, single catheter image-guided system designed to meet the 21st century needs of vascular access for hemodialysis. With this authorization, Avenu can now launch the technology at clinical centers of excellence throughout Europe.

A groundbreaking innovation for dialysis patients and clinicians, Avenu’s Ellipsys is the first medical device to be approved for study under an Investigational Device Exemption (IDE) by the FDA for minimally invasive creation of arteriovenous (AV) fistulas. The current gold standard of surgical fistula creation was established in 1966 and has not been significantly advanced since its inception 50 years ago.

News of Avenu receiving the CE Mark also comes on the heels of the company reaching full patient enrollment in its FDA-authorized pivotal phase III IDE clinical trial. This multi-center study is designed to demonstrate the safety and efficacy for the percutaneous creation of AV fistulas. The Company intends to file for FDA market authorization later this year.

Dialysis patients require consistent, effective, reproducible, and permanent vascular access. Meanwhile, surgical AV fistulas fail 40-60% of the time, often take several months to achieve usability and require multiple interventions to maintain functionality. In addition, patients often wait five months or longer to get a functioning surgical AV fistula. These factors result in the patients’ extended exposure to central venous catheters, which can lead to increased risks for infection and mortality. Avenu’s Ellipsys System introduces a modern alternative. Thanks to this new technology, clinicians now have a less invasive alternative to the creation of AV fistulas.

More details can be found from Avenu Medical website.