Laminate Medical Technologies has recruited first forearm fistula patients in its US pivotal trial designed to assess the VasQ device.
VasQ is an implanted blood vessel external support developed to improve maturation and decrease the high primary failure rate of surgically created fistulas for hemodialysis.
Holding CE mark approval, VasQ device is intended for patients suffering from kidney failure and is currently used in hospitals in Europe and Israel.
According to the company, the forearm fistula is the gold standard for vascular access creation but also has the highest risk of primary failure.
The addition of the forearm fistula to the US pivotal trial of VasQ will help improve overall care for dialysis patients.
Boston-based Brigham and Women’s Hospital’s by Dr. Samir Shah implanted the first surgical VasQ for a forearm fistula patient. It was followed by Dr Eric Peden of Houston Methodist and Dr John Lucas of Greenwood Leflore Hospital.
Dr Lucas said: “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.”
The prospective, multi-centre, single-arm, open-label and 15-site study will enrol 129 male and female patients aged between 18 and 80 years old, who require the creation of an arteri arteriovenous fistula for hemodialysis.
Laminate’s study has expanded enrollment to include patients indicated to receive a forearm fistula, while the original study protocol focused on upper arm fistulas.
The primary patency rate six months after the creation of the arteriovenous fistula with VasQ implantation is the primary effectiveness endpoint for this trial.
Laminate CEO Tammy Gilon said: “Following a very successful expansion in Europe to treat forearm fistula patients with VasQ, and excellent clinical outcomes that were presented in international conferences, the inclusion of forearm fistula patients in the pivotal study marks an important step toward VasQ market clearance in the US and a promising milestone for patients with kidney failure.”