TEL AVIV, Israel--(BUSINESS WIRE)--Laminate Medical Technologies (Laminate) has announced the enrollment of their first forearm fistula patients in their US pivotal trial of the 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. The forearm fistula is the gold standard for vascular access creation but also has the highest risk of primary failure. The inclusion of the forearm fistula to the US pivotal trial of VasQ represents a significant potential advancement for dialysis patients to help improve their overall care.
The first surgical VasQ implantation for a forearm fistula patient was performed by Dr. Samir Shah at the Brigham and Women’s Hospital in Boston, who was quickly followed by Dr. Eric Peden of Houston Methodist and Dr. John Lucas of Greenwood Leflore Hospital. Dr. Lucas remarked, "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 VasQ US pivotal clinical trial is a prospective, multi-center, single-arm, open-label, 15-site study enrolling 129 male and female patients, 18 to 80 years old, who require creation of an arteriovenous fistula for hemodialysis. The original study protocol focused on upper arm fistulas, but now the study has expanded enrollment to include patients indicated to receive a forearm fistula. The primary effectiveness endpoint for this trial is the primary patency rate 6 months after creation of the arteriovenous fistula with VasQ implantation. Patients will be followed for a total of 2 years to additionally assess long-term durability.
“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”, said Laminate CEO Tammy Gilon.
Developed by Laminate, a privately-held company that has recently completed a $12M financing, VasQ is intended for patients suffering from kidney failure and in need of hemodialysis, which requires vascular access. Hemodialysis requires the creation of a vascular access to facilitate a sufficiently high transfer of blood volume from the patient to an external dialysis machine for filtration of waste and toxins, then back to the patient in a minimal amount of time. The most common and preferred method of vascular access is an arteriovenous fistula created by a direct surgical connection of an artery and a vein, ideally as distal as possible on the arm
Unfortunately, primary failure rates of arteriovenous fistulas have been reported as high as 60% as the vein tends to elicit a negative biomechanical response to the altered hemodynamics and excessive wall tension that constricts the vein and reduces blood flow in the weeks following surgery. As a result, the patient must have repeat procedures to save the fistula or, in cases where the fistula cannot be used, abandon it in favor of other, less preferred vascular access alternatives. This common failure mode affects the ability for the patient to receive dialysis through a fistula and creates a burden on the hospital's resources.
VasQ is an external support placed over the fistula at the creation site promoting a positive biomechanical response by optimizing hemodynamics and minimizing wall tension post-surgery, 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. Several studies in Europe and Israel have reported an overall low primary failure rate of VasQ fistulas relative to the standard of care. VasQ is a CE Marked device already benefiting patients in Europe and Israel with impressive results. VasQ is currently under investigational use in the US.
About Laminate Medical Technologies
Laminate Medical Technologies was founded in 2012 by Tammy Gilon and Dr. Eyal Orion, who began their work in the Rad-Biomed incubator. Laminate has developed VasQ, a blood vessel support device for patients receiving dialysis. VasQ is CE Marked and used in hospitals in Europe and Israel.