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.
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.