Laminate’s VasQ Nabs De Novo Nod to Create AVFs for Dialysis Access

Laminate Medical Technologies’ flagship VasQ external vascular support device has obtained U.S. Food and Drug Administration (FDA) clearance to create arteriovenous fistulas (AVFs) for dialysis access.
 
VasQ is a nitinol-based device implanted around the artery and vein when surgically creating an AVF. The device was designed for structural reinforcement of mobilized vessels now free from native supporting tissue, and guiding a more stable arterial flow profile as it transitions into the vein.
 
The FDA designated VasQ as a breakthrough device and cleared it based on a De Novo review of the company’s 144-patient U.S. clinical study. The study, recently published in the Journal of Vascular Access, showed that VasQ patients in the pivotal study met the primary endpoint of improved primary patency—freedom from intervention and adequate flow for hemodialysis—at six months.
 
Ellen Dillavou, division chief of vascular surgery at WakeMed Hospital Systems, told the press, “I, along with other U.S. study investigators who have used the device, are excited that we can now offer VasQ to our fistula patients. We believe this will give our patients a better chance to receive a functioning fistula with fewer additional procedures and will allow earlier removal of central venous catheters before they lead to serious infections.”
 
Additional analysis comparing VasQ patients against claims data for traditional AVFs created by the same surgeons in the study reported “statistically superior” rates of functional success (confirmed use of the AVF for dialysis) and lowered need for further procedures. The result was central venous catheters—the primary source of hospitalization due to infection in dialysis patients—could be removed in 80% of patients within the first year, compared to 62% of unsupported fistulas.
 
“We are excited to finally bring VasQ to the U.S. dialysis patient population,” added Laminate CEO Tammy Gilon. “We could not be more appreciative of our U.S. principal investigators as well as the global community of dialysis access physicians that saw the potential in VasQ and produced the wealth of data supporting the devices safety and effectiveness.”
 

Watch a demonstration video of VasQ below!