February 4, 2020
Enrollment Completed in Pivotal Trial of Laminate’s VasQ Device
February 4, 2020—Laminate Medical Technologies announced that the United States' pivotal trial of their VasQ external support device has completed enrollment. The prospective, multicenter, single-arm study enrolled 144 patients in need of an arteriovenous fistula (AVF) for hemodialysis at 17 sites across the United States.
Patients requiring both brachiocephalic and radiocephalic AVFs were included, and patients will be followed for 2 years with the primary endpoint of primary patency analyzed at 6 months.
VasQ is a nitinol external support device designed to address hemodynamic and mechanical factors associated with AVF failure. It is placed around the artery and vein at the creation site, optimizing the transition of arterial flow to the vein and reinforcing the vessel wall against mechanical stress.
In 2019, a randomized controlled trial in the United Kingdom and Israel published by Nikolaos Karydis, MD, et al in American Journal of Kidney Diseases evaluated the device’s safety and efficacy and demonstrated significant improvement in fistulas becoming functional with VasQ compared with the standard of care. The company noted that the clinical benefits of VasQ experienced in Europe are expected to be validated in the United States within the fully enrolled pivotal study.
Ellen Dillavou, MD, who is with Duke University in Durham, North Carolina, commented, “VasQ promises to be a new standard of care for fistula creation to give my hemodialysis patients the greatest probability of success. The device has performed as expected in my study patients so far, and I look forward to continuing to utilize it once commercially available in the United States.”
VasQ is CE Marked in Europe and Israel and not currently available in the United States.