Laminate Medical Technologies Announces FDA Clearance for VasQ™ External Support

Thursday, September 28, 2023

Laminate Medical Technologies has received FDA clearance for its VasQ External Vascular Support device, intended for creating arteriovenous fistulas (AVFs) to facilitate dialysis access.

VasQ is a nitinol-based device surgically implanted around the artery and vein to create an arteriovenous fistula. Its primary design objectives are to offer structural reinforcement to the mobilised vessels, which are separated from their native supporting tissue, and to guide a smoother arterial flow profile as blood transitions into the vein. 

The device's effectiveness is substantiated by MRI-based imaging and computational fluid dynamic models, which provide strong evidence for its proposed mechanistic benefits. These benefits have consistently translated into positive clinical outcomes across multiple studies.

With the utilisation of VasQ, patients stand a much better chance of obtaining a fully functioning fistula, requiring fewer additional medical procedures. Furthermore, this approach allows for the early removal of central venous catheters, mitigating the risk of serious infections. Patients who participated in the VasQ U.S. pivotal study successfully met the primary endpoint of achieving improved primary patency at the critical 6-month mark.