Revolutionary Advancement: VasQ™ External Support Gains FDA Clearance to Transform Arteriovenous Fistula Creation

Laminate Medical Technologies is making waves in the world of medical innovation with its VasQ External Vascular Support. This groundbreaking device has just received the coveted FDA clearance, and it’s set to redefine how arteriovenous fistulas (AVFs) are created for dialysis access.

Designated as a Breakthrough Technology by the FDA, VasQ’s journey to clearance was marked by a rigorous De Novo review, taking into account the remarkable 144-patient VasQ U.S. Pivotal Study. What’s more, its track record of safety and effectiveness in international studies added weight to its credentials.

The Journal of Vascular Access recently showcased the success story of VasQ, with patients from the VasQ U.S. Pivotal Study achieving the primary endpoint: improved primary patency at 6 months. Astonishingly, not a single serious adverse event related to the device was reported during the two-year study.

But that’s not all. When VasQ patients were compared against traditional AVFs created by the same surgeons, the results were nothing short of revolutionary. Statistically superior rates of functional success, along with a reduced need for additional procedures, were the highlights.

This translates to a game-changing 80% of patients having central venous catheters (CVC) removed within the first year, a remarkable leap compared to the 62% reported for unsupported fistulas by the National Institute of Health’s United States Renal Data System. It’s not just a device; it’s a lifeline for dialysis patients.

In a momentous announcement, Ellen Dillavou, the Division Chief of Vascular Surgery at WakeMed Hospital Systems, shared her excitement about the FDA clearance for VasQ. She, along with other esteemed U.S. study investigators, is thrilled to offer VasQ to fistula patients, believing it holds the key to a brighter future.

With VasQ, patients stand a better chance of receiving a functioning fistula while minimizing the need for additional procedures. The icing on the cake? It allows for the early removal of central venous catheters, potentially preventing serious infections.

So, what makes VasQ so extraordinary? It’s a nitinol-based device that works its magic during the surgical creation of an arteriovenous fistula. Picture it as the ultimate support system for arteries and veins, reinforcing them as they embark on their journey without their native supporting tissue.

But that’s not all; VasQ also acts as a guide, ensuring a stable arterial flow profile as it transitions into the vein. The science behind VasQ is nothing short of remarkable, backed by MRI-based imaging and computational fluid dynamic models that validate its mechanistic benefits.

Tammy Gilon, the visionary CEO of Laminate, couldn’t be more thrilled. She expressed her excitement about bringing VasQ to the U.S. dialysis patient population, expressing deep appreciation for U.S. principal investigators and the global community of dialysis access physicians. Their unwavering support and the wealth of data they’ve generated have been instrumental in VasQ’s journey to transform lives.

About Laminate Medical Technologies

In the realm of healthcare innovation, there exists a visionary duo: Tammy Gilon and Dr. Eyal Orion, the founders of Laminate Medical Technologies. Their mission, sparked in 2012, is nothing short of revolutionary—to enhance the lives of dialysis patients grappling with arteriovenous fistulas (AVFs).

At the heart of their endeavor is VasQ™ External Support, Laminate’s flagship product. This groundbreaking device has emerged as a beacon of hope, successfully combating the alarming rate of fistula failures and the need for repeat procedures that have burdened hemodialysis patients for far too long.

But Laminate’s journey doesn’t end here. They are driven by an unwavering commitment to innovation, with additional devices currently in development. These upcoming solutions are poised to tackle the challenges faced by AVF patients head-on, offering a brighter future and improved quality of life. Laminate Medical Technologies isn’t just changing the game; they’re rewriting the narrative of dialysis care, one breakthrough at a time.

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