Enrollment Complete for VALUE, the Prospective EU VasQ(TM) External Support Post-Market Study
TEL AVIV, Israel, Dec. 11, 2019 /PRNewswire/ -- Laminate Medical Technologies (Laminate) has announced the completion enrollment of the VALUE study for the VasQ™ External Support. The post-market study enrolled 80 patients (50 upper arm and 30 forearm fistulas) for sites across Germany, France, Spain and the UK and will be followed for one year. The study is the first prospective study to assess the use of the device in the forearm. The forearm fistula carries a higher risk of primary failure relative to upper arm fistulas but is preferred by surgeons as it preserves more options for the patient's future access needs.
VasQ is intended to promote usability of both forearm and upper arm fistulas by providing an external support to optimize the hemodynamics and reinforce against the excessive mechanical stress experienced by the surgically created connection of the vein to the artery. The clinical benefits of VasQ has been demonstrated over the standard of care for upper arm fistulas in a randomized-controlled study recently published in the American Journal of Kidney Disease. For the VALUE study, an interim analysis of the first 63 patients enrolled was released this fall, which reported similarly beneficial clinical outcomes for both upper arm and forearm fistulas.
Dr. Gaspar Mestres of the Cardiovascular Institute Hospital Clinic, Barcelona, Spain stated, "VasQ has become an essential part of my clinical practice to give my patients' fistulas a greater chance for success. Increasing usability and minimizing reinterventions with VasQ provides tremendous benefit to my patients' health while on hemodialysis. I am excited to see the longer-term benefits of the device for both forearm and upper arm fistulas validated for clinics across Europe in VALUE."
"We are grateful to our principle investigators for their participation in VALUE," said Laminate CEO Tammy Gilon. "The expansion of our clinical evidence to support the benefits of VasQ in forearm patients is critical to our company goal of reducing fistula primary failure rates globally."
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.
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SOURCE Laminate Medical Technologies