FDA Approves IDE for Clinical Study of Laminate Medical Technologies' VasQ Device
August 1, 2017—Laminate Medical Technologies, an Israel-based company, announced that it has received investigational device exemption approval from the US Food and Drug Administration (FDA) to evaluate the safety and efficacy of the company's VasQ device in clinical trials in the United States, with the goal of obtaining FDA marketing approval.
VasQ is an implanted blood vessel external support device for patients requiring arteriovenous fistula as vascular access for hemodialysis.
The prospective, multicenter, single-arm, open-label, 13-site study will enroll 129 male and female patients (aged 18 to 80 years), who require creation of a new brachiocephalic fistula.
During screening, physicians will assess additional eligibility criteria such as adequate blood vessel anatomy and the absence of comorbidities that may potentially preclude treatment. The primary effectiveness endpoint for this trial will be the primary patency rate at 6 months after creation of the arteriovenous fistula. Patients will be followed for a total of 2 years.
VasQ is intended for vascular access for patients with kidney failure in need of dialysis. VasQ is an external scaffold placed over the fistula, creating an optimal geometric configuration with the artery and reducing the tension in the vein. This allows proper blood flow during dialysis while reducing vein blockage created by thickening of the vein wall. The VasQ device has received CE Mark approval and is available in Europe and Israel. FDA–approved clinical trials are now planned, advised the company.