Laminate Medical Technologies has announced their flagship device, the VasQ external vascular support, has been cleared by the Food and Drug Administration (FDA) for use to create arteriovenous fistulas (AVFs) for dialysis access. The device, designated by the FDA as a breakthrough technology, was cleared based on a de novo review of the 144 patient VasQ U.S. pivotal study, as well as a track record of safety and effectiveness of use in multiple studies from outside the U.S.
As recently published in the Journal of Vascular Surgery, VasQ patients in the VasQ study met the primary endpoint of improved primary patency (freedom from intervention plus adequate flow for hemodialysis) at six months. No serious adverse event associated with the device was reported over the two year study.
Additional analysis comparing VasQ patients against claims data for traditional AVFs created by the same surgeons in the study, reported statistically superior rates of functional success (confirmed use of the AVF for dialysis), and reduced need for additional procedures. The result was central venous catheters (CVC), the primary source of hospitalization due to infection in dialysis patients, were able to be removed in 80% of the patients within the first year as compared to 62% of unsupported fistulas as reported by the National Institute of Health’s United States Renal Data System.
Ellen Dillavou, MD, division chief of vascular surgery at WakeMed Hospital Systems in Raleigh, North Carolina, stated, “I, along with other study investigators who have used the device, are excited that we can now offer VasQ to our fistula patients. We believe this will give our patients a better chance to receive a functioning fistula with fewer additional procedures and will allow earlier removal of central venous catheters before they lead to serious infections.”
VasQ is a nitinol-based device implanted around the artery and vein during the surgical creation of an arteriovenous fistula. The device was designed to provide structural reinforcement of the mobilized vessels now freed from its native supporting tissue as well as guides a more stable arterial flow profile as it transitions into the vein. Magnetic resonance imaging as well as computational fluid dynamic models have supported the proposed mechanistic benefits of the VasQ design that have led to consistent beneficial clinical outcomes in multiple studies.