The study will evaluate the technology to enhance the maturation of arteriovenous fistulas in haemodialysis patients. Credit: Tyler Olson / Shutterstock.com.

Alucent Biomedical has announced plans to commence a clinical trial of its AlucentNVS technology in the US.

The decision comes after the US Food and Drug Administration (FDA) granted an investigational device exemption (IDE) for the study.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

The study will evaluate this technology to promote the maturation of arteriovenous fistulas (AVF) in haemodialysis patients.

AlucentNVS integrates an intravascular device with a photochemical process for connecting structural proteins in a blood vessel wall to control vascular remodelling.

The intervention is intended to promote the patency of the vessel’s lumen and create sustained improvements in blood flow.

See Also:

The technology helps retain the vascular wall’s natural functionality and flexibility.

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.

Furthermore, the company will leverage its AlucentNVS technology in the surgical AVF creation procedure to enhance the success rate of AV fistula maturation.

Alucent Biomedical CEO Dr Myles Greenberg said: “This second IDE approval by the FDA will allow us to advance our goal to offer physicians and patients a more successful approach to initiating haemodialysis through an AVF in patients with kidney failure, a life-saving procedure where failure rates are still unacceptably high.

“We believe our technology has the potential to transform the current standard of care for patients requiring dialysis.”

The latest development comes after the company received its initial FDA IDE approval in August of this year.

The Activate AVF feasibility trial has already started and is currently enrolling subjects at locations in Poland and Australia.