A Laminate Medical Technologies press release reports that the US VasQ external support comparative study results were presented this month for the first time globally at the 2022 Vascular Access for Hemodialysis Symposium (VASA; 9–11 June, Charleston, USA).
The study was a propensity-score matched comparison of the VasQ US pivotal study single-arm prospective data with untreated contemporary Medicare patients who underwent arteriovenous fistula creation for haemodialysis by the same study surgeons. According to a company press release, the study results demonstrated a significant improvement in primary patency and fistula usability with less reintervention burden within the first six months post-creation.
C Keith Ozaki (Brigham and Women’s Hospital, Boston, USA), 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 haemodialysis access usability with the VasQ device. These data support similar results from multiple European studies on VasQ’s ability to reduce intervention burden on haemodialysis patients.”
The data release at VASA builds on previous VasQ US pivotal study data releases, first by Ellen Dillavou (WakeMed, Raleigh, USA), who reported at the VEITHsymposium 2021 (16–20 November, Orlando, USA) that VasQ met the primary effectiveness performance goal, and second by John Lucas III (Greenwood Leflore Hospital, Greenwood, USA), who reported at the Charing Cross (CX) Symposium 2022 (26–28 April, London, UK) high secondary patency rates at two years as compared to published contemporary US meta-analyses.
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.”
Laminate Medical Technologies advises that VasQ is currently under review by the US Food and Drug Administration (FDA) for market clearance and is not available for sale in the USA at the time of this announcement.