July 26, 2019
First Forearm Fistula Patients Enrolled in Pivotal Trial of Laminate's VasQ Device
July 24, 2019—Laminate Medical Technologies announced the enrollment of their first forearm fistula patients in the United States pivotal trial of the company’s VasQ device. VasQ is an implanted blood vessel external support intended to promote maturation and reduce the high primary failure rate of surgically created fistulas for hemodialysis.
According to the company, the VasQ United States pivotal clinical trial is a prospective, multicenter, single-arm, open-label, 15-site study enrolling 129 male and female patients from 18 to 80 years old who require the creation of an arteriovenous fistula for hemodialysis. The original study protocol focused on upper arm fistulas, but the study has now expanded enrollment to include patients who are indicated to receive a forearm fistula.
The primary effectiveness endpoint for this trial is the primary patency rate 6 months after the creation of the arteriovenous fistula with VasQ implantation. Patients will be followed for a total of 2 years to additionally assess long-term durability.
The first surgical VasQ implantation for a forearm fistula patient was performed by Samir Shah, MD, at the Brigham and Women’s Hospital in Boston, Massachusetts. Additional early procedures were performed by Eric Peden, MD, of Houston Methodist in Houston, Texas, and John Lucas, MD, of Greenwood Leflore Hospital in Greenwood, Mississippi.
In the company’s announcement, Dr. Lucas stated, “There is a pressing worldwide need for technologies to improve fistula outcomes, and the early results with the VasQ device based on European data have been promising. I am excited about the potential of this device to assist the maturation of the fistulas that I create for my patients. VasQ was easy to place and the immediate outcomes were excellent.”
Laminate’s VasQ is intended for patients with kidney failure and in need of hemodialysis, which requires vascular access. The device is an external support placed over the fistula at the creation site, promoting a positive biomechanic response by optimizing hemodynamics and minimizing wall tension postsurgery, which leads to vein dilation instead of constriction. This reduces the risk of primary failure and allows the fistula to achieve sufficient blood flow during dialysis.
The company noted that studies in Europe and Israel have reported an overall low primary failure rate of VasQ fistulas relative to the standard of care. VasQ has European CE Mark approval. In the United States, it is available for investigational use.