August 22, 2019
Study Supports Laminate's VasQ External Support Device for Newly Created Arteriovenous Fistulas in Hemodialysis Patients
August 23, 2019—Laminate Medical Technologies announced that the first multicenter, randomized controlled study of the company's VasQ external support device for newly created arteriovenous fistulas (AVFs) in hemodialysis patients was published online ahead of print by Nikolaos Karydis, MD, et al in American Journal of Kidney Diseases.
The Israel-based company noted that AVFs are the standard of care for delivering life-sustaining hemodialysis but also carry the highest rate of failure to develop into functional dialysis accesses. The results of the study demonstrate a significant improvement in fistulas becoming functional with VasQ as compared with the standard of care (AVF placement without the device). VasQ has received CE Mark approval and is used in hospitals in Europe and Israel, advised Laminate.
According to the company, the randomized controlled study was designed to evaluate the safety and efficacy of VasQ in improving the short-term and midterm outcomes of AVFs with VasQ for hemodialysis versus the standard of care.
The study enrolled 40 patients who were randomized 1:1 and followed for 6 months. The study was conducted at Sheba Medical Center in Ramat Gan, Israel, and at three hospitals in the United Kingdom: Guy’s and St Thomas’ NHS Foundation Trust in London; Southmead Hospital—NHS in North Bristol; and St. George’s University Hospitals Foundation Trust in London.
The company reported that the outcomes demonstrated significant improvement in functional patency with increased intraluminal vein diameters in the cannulation segment (a key factor to enable good fistula function) at 3 months after fistula creation. Conversely, stenosis (the leading cause of fistula failure) occurred in 15% of VasQ patients versus 50% of control (P = .04).
The end result was 100% of VasQ patients who required hemodialysis during the 6-month study period received the treatment via their fistula as compared with 56% of patients in the control group (P = .01). No safety issues were detected when comparing patients implanted with VasQ as compared with the control.
Dr. Karydis, who is Principal Investigator of the study, commented in the announcement, "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."
Additionally, Dr. Karydis, who is with the Department of Nephrology and Transplantation at Guy's and St. Thomas' NHS Foundation Trust, stated, "If physicians 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."