Pivotal Trial of Laminate's VasQ Device Begins in the United States
January 18, 2018—Laminate Medical Technologies announced the launch of its United States pivotal study for the company's VasQ implanted blood vessel external support device for patients requiring arteriovenous fistula (AVF) as vascular access for hemodialysis.
According to the company, the prospective, multicenter, single-arm, open-label study will be conducted at 133 sites. Investigators will enroll 129 male and female patients, aged 18 to 80 years, who require creation of new brachiocephalic fistula. During screening, investigators will assess additional eligibility criteria such as adequate blood vessel anatomy and absence of potentially precluding past and current medical conditions and comorbidities. The trial's primary effectiveness endpoint is the primary patency rate at 6 months after creation of the AVF. Patients will be followed for 2 years.
The first procedures in the trial were performed by Jason Burgess, MD, and Paul Orland, MD, at the Carolinas Medical Center-Mercy in Charlotte, North Carolina.
In the company's announcement, Dr. Burgess commented, "We are excited to be the first site that enrolled patients in the United States. The device was easy to implant, and I am happy with the surgical results. We are looking forward to evaluating the device's long-term effect."
Dr. Orland added, "The device was easy to handle and I was very happy with the postoperative results. This new technology is targeting the major problems of AVFs: maturation and long-term longevity of the fistula."
Laminate describes VasQ as an external scaffold placed over the fistula, creating a 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 commercially available in Europe and Israel, advised the company.