Laminate Medical Technologies today announced it has won FDA breakthrough device designation for its VasQ external support for patients in need of an arteriovenous fistula (AVF) for hemodialysis.
Tel Aviv, Israel–based Laminate’s VasQ device is a nitinol external support placed around the artery and vein at the creation site. It is designed to optimize the transition of arterial flow to the vein while it reinforces the vessel wall against an increase in mechanical stress.
The company completed enrollment of a U.S. investigational device exemption pivotal trial in February. A total of 144 current and pre-dialysis patients referred for fistula creation were included in the study for either a brachiocephalic or radiocephalic fistulas with VasQ. Follow-up for the study’s primary endpoints are expected by August 2020 and will be evaluated by the FDA through the de novo pathway, according to Laminate Medical. The patients will be followed for two years.