Laminate’s VasQ External Support Device for AV Fistula Creation Evaluated in Comparative Study in the United States

June 21, 2022—Laminate Medical Technologies announced that results from the United States VasQ External Support Comparative Study were presented for the first time globally at the Vascular Access Societies of the Americas (VASA) 2022 Vascular Access for Hemodialysis held June 9-11 in Charleston, South Carolina.

The study is evaluating the company’s VasQ external support for the creation of arteriovenous fistulas (AVFs) in hemodialysis patients. The VasQ device is currently under review by the FDA for market clearance and is not available for sale in the United States. VasQ was granted Breakthrough Device designation from the FDA in June 2020.

According to the company, the study was a propensity-score matched comparison of the VasQ United States Pivotal Study single-arm prospective data with untreated contemporary Medicare patients who underwent AVF creation for hemodialysis by the same study surgeons. The study results demonstrated a significant improvement in primary patency and fistula usability with less reintervention burden within the first 6 months post creation, noted Laminate.

C. Keith Ozaki, MD, the local principal investigator for the phase 3 pivotal study, commented in the company’s press release, “The results of this carefully performed analysis clearly link higher patency, lower reintervention rates, and increased hemodialysis access usability with the VasQ device. These data support similar results from multiple European studies on VasQ’s ability to reduce intervention burden on hemodialysis patients.” Dr. Ozaki is a vascular surgeon and Executive Vice-Chair of the Department of Surgery at Brigham and Women’s Hospital in Boston, Massachusetts.

Laminate Medical Technologies noted that the data presented at VASA builds on previous VasQ United States Pivotal Study data, including findings that showed the VasQ met the primary effectiveness performance goal, which Ellen Dillavou presented, MD, at the 2021 VEITHsymposium held November 16-20 in Orlando, Florida. Dr. Dillavou is Chief of Surgery at WakeMed in Raleigh, North Carolina.

Additionally, at the 2022 Charing Cross International Symposium held April 26-28 in London, United Kingdom, John Lucas III, MD, revealed high secondary patency rates at 2-years as compared to published contemporary United States meta-analyses. Dr. Lucas is a vascular surgeon at Greenwood Leflore Hospital in Greenwood, Mississippi.

Dr. Dillavou commented in the company’s press release, “The mounting volume of evidence for VasQ continues to support the adoption of this technology as standard practice for access creation in order to give our patients the best chance for successful dialysis with a fistula and expediting removal of central venous catheters.”