Laminate Medical Technologies has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to start clinical study of the VasQ device.
The prospective, multi-center, single-arm, open-label, 13-site study will enroll 129 male and female patients, 18 to 80 years old, who require creation of new brachiocephalic fistula.
During screening, surgeons will assess additional eligibility criteria such as adequate blood vessel anatomy and absence of potentially precluding past and current medical conditions and comorbidities.
The primary effectiveness endpoint for this trial will be the primary patency rate 6 months after creation of the arteriovenous fistula. Patients will be followed for a total of 2 years.
“IDE approval for this pivotal study marks an important step forward for VasQ in the American market and a promising milestone for patients with kidney failure,” said Laminate CEO Tammy Gilon.
“The current technique for creating an arteriovenous fistula is over 50 years old, but is still associated with high failure rates over time, requiring dialysis patients to undergo multiple surgical or endovascular procedures to keep their fistula functioning. This is a very traumatic process for people already coping with kidney failure. We hope that this step forward will advance VasQ toward changing that process in the United States, as it already has done in Europe.”
Developed by Laminate, VasQ is intended for patients suffering from kidney failure and in need of dialysis, which requires vascular access. The most common and preferred method of vascular access is an arteriovenous fistula, created by surgically suturing a blood vessel connection between an artery and a vein, usually in the region of the wrist or the elbow.
Two intravenous needles are inserted through the vein to remove the patient's blood for filtration in the dialysis machine, and then return it. This connection ensures a sufficiently high transfer of blood volume (veins do not transfer sufficient volume, while arteries are too deep for repeated insertion of a needle).
Unfortunately, a venous blockage forms in more than half of these cases. In response to increased pressure, the vein wall thickens, which in turn affects the blood flow during dialysis. As a result, the patient must have repeat interventions to save the fistula or, in cases where the fistula cannot be used, use other vascular access alternatives affecting the ability to receive dialysis and creating a burden on the hospital's resources.
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.
Studies show VasQ has significant success. VasQ is a CE Marked device already in use in hospitals in Europe and in Israel, with impressive results.