Friday, November 22, 2019
Breaking Medical Device Industry News

VasQ™ External Support Demonstrates Significant Improvement in Fistula Usability in the Newly Published Multi-Center Randomized-Controlled Study

Friday, November 22, 2019

Laminate Medical Technologies (Laminate) has announced that the American Journal of Kidney Disease has published the first multi-center, randomized-controlled study of the VasQ™ External Support for newly created arteriovenous fistulas in hemodialysis patients. Arteriovenous fistulas are the standard of care for delivery of life-sustaining hemodialysis but also carry the highest rate of failure to develop into functional dialysis accesses. The results of the newly published study demonstrate a significant improvement in fistulas becoming functional with VasQ as compared to the standard of care.

The randomized-controlled study was designed 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 40 patients randomized 1:1 and followed for 6 months. The study was conducted at Guy’s and St Thomas’ NHS Foundation Trust (London, UK); Southmead Hospital – NHS (North Bristol, UK); St. George’s University Hospitals Foundation Trust (London, UK) ; and Sheba Medical Center (Ramat Gan, Israel).

The outcomes demonstrated significant improvement in functional patency with increased intra-luminal vein diameters in the cannulation segment (a key factor to enable good fistula function) at 3-months post fistula creation. Conversely, stenosis (the leading cause of fistula failure) occurred in 15% of VasQ patients as opposed to 50% of control (P = .04). The end result was 100% of VasQ patients who required hemodialysis during the 6-month study period received it via their fistula as compared to 56% of patients in the control patients (P = .01). No safety issues were detected when comparing patients implanted with VasQ as compared to the control.

Principal investigator Dr. Nikolaos Karydis of Guy’s and St Thomas’ 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.”

Laminate CEO Tammy Gilon stated, “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.”

 

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