A Randomized MRI-Based Study Reveals VasQ External Support Promotes More Stable Hemodynamics than Standard AVFs

Dr. Andrea Remuzzi and his research team at The University of Bergamo have recently published a randomized-controlled MRI-based computational fluid dynamic study in the Journal of Vascular Access that revealed the impact of VasQ™ External Support on fistula morphology and flow.

VasQ External Support, a Laminate Medical Technologies device is implanted around the connection between the vein and artery during the creation of an arteriovenous fistula (AVF) for hemodialysis patients with the intent to provide structural reinforcement and promote a more stable flow profile.

The MRI study confirmed the device retained a more optimal geometric configuration over the 1-year study period, which promoted a more stable hemodynamic profile. Control patients on the other hand, experienced significant morphological changes, such as atrial “tenting” and angular degradation, that resulted in either an aneurysmal or stenotic AVF with a less stable flow profile.

Dr. Remuzzi stated that, “Morphology is an important surgical consideration to create favorable hemodynamics for fistula maturation and long-term success. Our initial results demonstrated that implanting the VasQ External Support during creation surgery can retain the desired fistula morphology over the long-term that otherwise maybe negatively altered as the tissue undergoes remodeling.”

Several clinical studies conducted in Europe and the U.S. have described an increase in the rate of fistula maturation to become usable for hemodialysis.1-4 However, Dr. Remuzzi’s study was the first of its kind to demonstrate the potential structural and hemodynamic effect of VasQ that may explain the consistent beneficial clinical outcomes that have been reported to date.

Tammy Gilon, Co-founder and CEO of Laminate, commented, “Seeing the vision my co-founder, Eyal Orion, and I had for the device when we first designed it ten years ago come to fruition in patients is a major milestone for Laminate. We appreciate the scientific rigor and expertise Dr. Remuzzi and his team provided in elucidating how VasQ works to create more usable fistulas.”

To date, Laminate has CE mark and has submitted for market clearance in the U.S. to the FDA.

The full publication is now available for open access at Journal of Vascular Access.

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