Laminate Medical has received breakthrough device designation from the US Food and Drug Administration (FDA) for its VasQ External Support for the creation of arteriovenous fistulas (AVF) in hemodialysis patients.

The designation was granted by the FDA based on the clinical data collected for VasQ, which demonstrates its improvement over the standard of care for creating functional AVF for hemodialysis treatment.

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.

To enable effective treatment for hemodialysis patients, physicians usually prefer AVF because of their long-term benefits.

However, AVF is said to have the lowest probability of actually becoming usable for hemodialysis in the short term.

It has reported success rates as low as 40% at one year, the company noted.

AVF created with the VasQ External support have consistently registered success rates as high as 86% or higher by six months in several clinical studies.

Laminate Medical Clinical and Regulatory Affairs vice-president Orit Yarden said: “This is a significant milestone for VasQ that will enable a faster and smoother regulatory process for the US market, as well as support the necessary reimbursement for the use of the device in clinical practice to benefit patients.”

VasQ is currently in a US IDE pivotal clinical study that is expected to have completed follow-up for its primary endpoints by August. It will be evaluated by the FDA through the de Novo Pathway.

The single-arm study prospectively enrolled its entire 144 male and female patient cohort from 15 sites across the US earlier in February.

The FDA will consider the results from the study and other clinical evidence collected from use of the device for the regulatory approval of the VasQ External Support.