The study was published in the American Journal of Kidney Disease and the results of the new study showed a significant improvement in fistulas with VasQ

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Image: Laminate’s randomized-controlled study was intended to evaluate the safety and efficacy of VasQ. Photo: Courtesy of valelopardo from Pixabay.

Laminate Medical Technologies, a privately-held start-up company, has announced the positive results of the first multi-center, randomised-controlled study of its VasQ External Support for VasQ External Support, for newly created arteriovenous fistulas in hemodialysis patients.

The arteriovenous fistulas are the standard of care for delivery of life-sustaining hemodialysis and also carry the highest rate of failure to develop into functional dialysis accesses.

The study was published in the American Journal of Kidney Disease and the results of the new study showed a significant improvement in fistulas with VasQ, compared to the standard of care.

Laminate CEO Tammy Gilon said: “The results of this randomized-controlled study are very encouraging and an important step to validating the benefits of external support for the application in dialysis patients worldwide. We are grateful to the investigators in our studies for leading the way in changing how fistulas are created.”

The study was carried out to evaluate the safety and efficacy of VasQ

The randomised-controlled study was intended to evaluate the safety and efficacy of VasQ in improving the Short and Mid-term outcomes of arteriovenous fistulas for hemodialysis versus the standard of care.

The study enrolled with 40 patients was conducted at Guy’s and St Thomas’ NHS Foundation Trust in London, Southmead Hospital in NHS North Bristol, St George’s University Hospitals Foundation Trust in London, and Sheba Medical Center in Ramat Gan, Israel.

In addition, the outcomes showed a significant progress in functional patency with increased intra-luminal vein diameters in the cannulation segment at 3-months post fistula creation. The leading cause of fistula failure, stenosis occurred in 15% of VasQ patients as opposed to 50% of control.

The end result of the study showed 100% of VasQ patients who required hemodialysis during the 6-month study period, as compared to 56% of patients in the control patients, and no safety issues were detected compared to the control.

Principal investigator Nikolaos Karydis said: “Rarely do you observe such a stark difference in outcomes between a new technology and the standard of care in dialysis access, a notoriously challenging patient population.

“The results suggest that VasQ has the potential to dramatically improve our global fistula outcomes for the betterment of our patients. If physician’s can consistently achieve functional patency as demonstrated in this study, we may avoid repeat interventions and prolonged exposure of patients to the high mortality risks of alternative therapies such as central venous catheters.”