Breakthrough Device Supports AVF in Hemodialysis Patients

A novel support mesh addresses the high rate of primary arteriovenous fistulas (AVF) failures and repeat procedures experienced by hemodialysis patients.

The Laminate Medical (Tel Aviv, Israel) VasQ External Support is a nickel titanium (nitinol) device designed to maintain the optimal configuration of the AVF anastomosis during remodeling, and promote outward wall thickening downstream during the critical weeks of maturation post-surgery and for eventual use during hemodialysis. Implanted during the AVF creation surgery, the VasQ results in a more laminar flow transition, a structurally reinforced juxta-anastomotic segment, venous tapering for smooth transition flow to the dilated fistula, and an arterial arch that guides blood flow towards the vein.

While AVFs are the preferred option for hemodialysis patients to enable effective treatment due to their long-term benefits, they have the lowest probability of actually becoming usable for hemodialysis in the short-term, with success rates as low as 40% at one-year. However, studies show that AVFs created in conjunction with VasQ External Support placement have consistently reported success rates as high as 86% or better by six months. The VasQ External Support has received breakthrough device by the US Food and Drug Administration (FDA; Silver Spring, MD, USA).

“Following a very successful expansion in Europe to treat forearm fistula patients with VasQ, and excellent clinical outcomes that were presented in international conferences, the inclusion of forearm fistula patients in the pivotal study marks an important step toward VasQ market clearance in the USA and a promising milestone for patients with kidney failure”, said Tammy Gilon, CEO of Laminate Medical.

“VasQ promises to be a new standard of care for fistula creation to give my hemodialysis patients the greatest probability of success,” said vascular surgeon Ellen Dillavou, MD of Duke University (Durham, NC, USA). “The device has performed as expected in my study patients so far, and I look forward to continue to utilize it once commercially available in the USA.”
An AVF is the most recommended access for kidney disease patients undergoing dialysis, created by connecting a patient's vein and artery to form a long-lasting site through which blood can be removed and returned. After the creation of an AVF, blood flow increases immediately, reaching 700–1,000 mL/min within one month. Both the artery and the vein dilate and elongate in response to the greater blood flow and shear stress, but the vein dilates more. When the vein is large enough to allow cannulation, the fistula is defined as mature.

Related Links:
Laminate Medical
US Food and Drug Administration