Laminate Medical’s VasQ External Support for AVF Creation Cleared by FDA

September 27, 2023—Laminate Medical Technologies announced that the company’s flagship device, the VasQ external vascular support, has received FDA clearance for the creation of arteriovenous fistulas (AVFs) for dialysis access. The device received the FDA’s Breakthrough Device designation in 2020.

Laminate stated that VasQ is a nitinol-based device implanted around the artery and vein during the surgical creation of an AVF. The device was designed to provide structural reinforcement of the mobilized vessels now freed from native supporting tissue as well as to guide a more stable arterial flow profile as it transitions into the vein.

According to the company, the VasQ device was cleared based on a de novo review of the 144-patient VasQ United States pivotal study, as well as findings of safety and efficacy in studies outside the United States.

In the pivotal study, patients treated with the VasQ device met the primary endpoint of improved primary patency (freedom from intervention plus adequate flow for hemodialysis) at 6-months. No device-related serious adverse events were reported during the 2-year study.

In July 2023, the pivotal study findings were published online by Ellen Dillavou, MD, et al in Journal of Vascular Surgery.

Dr. Dillavou commented in Laminate’s press release, “I, along with other United States 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.” Dr. Dillavou is Division Chief of Vascular Surgery at WakeMed Hospital Systems in Raleigh, North Carolina.

The company advised that additional analysis comparing VasQ patients against claims data for traditional AVFs created by the same surgeons in the study demonstrated statistically superior rates of functional success (confirmed use of the AVF for dialysis) and reduced need for additional procedures. The results showed that central venous catheters, which are the primary source of hospitalization because of 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.

Additionally, the company noted that magnetic resonance imaging and 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, including findings published in April 2022 by biomedical engineer Michela Bozzetto et al online in Journal of Vascular Access.

In June 2022, the company announced that results from the United States VasQ External Support Comparative Study were presented for the first time globally at VASA 2022, the Vascular Access Societies of the Americas’ Vascular Access for Hemodialysis conference in Charleston, South Carolina.