Laminate Medical Technologies (Laminate), a privately held start-up developing VasQ, an implanted blood vessel external support device for patients requiring arteriovenous fistula as vascular access for hemodialysis, declared the launch of its FDA pivotal study in the US.
The first surgeries were performed at the Carolinas Medical Center-Mercy, Charlotte, North Carolina by Dr. Jason Burgess and Dr. Paul Orland.
“We are eager to be the first site that enlisted patients in the US. The VasQ device was easy to implant and I am happy with the surgical outcomes. We are looking forward to evaluating the device’s long-term effect”, said Burgess.
“I was happy with the postoperative outcomes of VasQ device and it was easy to handle. This new technology is targeting on the major issues of AVFs: maturation and long-term longevity of the fistula”, said Orland.
The prospective, multicenter, single-arm, open- label, 13-site study will enlist 129 male and female patients, 18 to 80 years of age, who require the creation of a new brachiocephalic fistula.
During the screening, surgeons will evaluate additional eligibility criteria such as adequate blood vessel anatomy and absence of potentially precluding past and current medical conditions and comorbidities.
The effective primary endpoint for this trial will be the primary patency rate a half year after production of the arteriovenous fistula. Patients will be taken after for a total of 2 years.
Laminate CEO Tammy Gilon said, “The launch of this pivotal study for VasQ device marks a vital step forward in the US market and a promising milestone for patients with kidney failure. We were excited to see the high level of interest and support from our partner sites when we offered them to take part in the study”.
Developed by Laminate, VasQ is intended for patients suffering from kidney failure and needing dialysis, which requires vascular access.
The most common and preferred method for 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 evacuate the patient’s blood for filtration in the dialysis machine and afterward, return it.
This connection ensures a sufficiently high transfer of blood volume (veins don’t transfer sufficient volume, while arteries are too deep for repeated insertion of a needle).
Unfortunately, a venous blockage forms in the greater part of these cases. In response to increased pressure, the vein wall thickens, which in turn affects the blood flow during dialysis.
Therefore, the patient must have repeat interventions to save the fistula or, in cases where the fistula can’t be used, use other vascular access alternatives affecting the ability to get dialysis and creating a burden on the hospital’s assets.
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 permits proper blood flow during dialysis while reducing vein blockage created by thickening of the vein wall.
Studies indicate VasQ has significant success. VasQ is a CE Marked device currently being used in hospitals in Europe and in Israel, with impressive outcomes.