Endologix has received an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to initiate a multi-centre study for assessing the safety and effectiveness of its Nellix endoVascular aneurysm sealing system for the endovascular repair of infrarenal abdominal aortic aneurysms.

EVAS FORWARD-IDE will enroll 180 patients at up to 30 sites in the US, Canada and Europe. This study is one of a number of studies that makes up the broader EVAS FORWARD clinical programme aimed at establishing clinical and economic evidence for EVAS using Nellix.

"We believe that Nellix has the potential to improve outcomes for patients and simplify AAA procedures for physicians."

Endologix has designed the Nellix EVAS system, a new generation of abdominal aortic aneurysm therapy, to seal the entire aneurysm with a biocompatible polymer.

According to the company, Nellix is an innovative new endovascular aneurysm sealing system designed to simplify endovascular procedures, treat a broader range of patients, and provide enhanced clinical outcomes.

Endologix chairman and CEO John McDermott said: "We believe Nellix has the potential to improve outcomes for patients and simplify AAA procedures for physicians. Based on the anticipated enrolment timeline and one-year follow up period, Nellix could potentially be available to physicians and patients in the US in the second half of 2016."

In January, the company obtained CE Mark approval for the Nellix system for the treatment of patients with abdominal aortic aneurysms. This approval includes a few enhancements intended to further optimise the device compared with the previous version, which obtained CE Mark in October 2012.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The company is in the process of commercially launching the product in Europe.