June 21, 2022 10:33 AM EDT (EZ Newswire)
CHARLESTON, SC -- The U.S. VasQ™ External Support Comparative Study results were presented this month for the first time globally at the VASA 2022. The study was a propensity-score matched comparison of the VasQ U.S. Pivotal Study single-arm prospective data with untreated contemporary Medicare patients who underwent arterio-venous fistula creation for hemodialysis by the same study surgeons. The study results demonstrated a significant improvement in primary patency and fistula usability with less re-intervention burden within the first 6 months post-creation.
Dr. C. Keith Ozaki, vascular surgeon and Executive Vice Chair of the Department of Surgery at Brigham and Women's Hospital of Boston, MA, and the local principal investigator for the phase 3 Pivotal study, stated, "The results of this carefully performed analysis clearly link higher patency, lower reintervention rates, and increased hemodialysis access usability with the VasQ device. This data supports similar results from multiple European studies on VasQ's ability to reduce intervention burden on hemodialysis patients."
The data release at VASA builds on previous VasQ U.S. Pivotal Study data releases, first by Dr. Ellen Dillavou, Chief of Surgery at WakeMed, NC, who reported at VEITH 2021 that VasQ met the primary effectiveness performance goal, and second, by Dr. John Lucas III, Vascular Surgeon at Greenwood Leflore Hospital, MS, who reported at Charing CX 2022, London UK, high secondary patency rates at 2-years as compared to published contemporary U.S. meta-analyses.
Dr. Dillavou added, "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."
VasQ is currently under review by the FDA for market clearance and is not available for sale in the U.S. at the time of this publication.