The VasQ™ External Support Now FDA Cleared for Use in Creating Arteriovenous Fistulas
TEL AVIV, Israel, Sept. 27, 2023 /PRNewswire/ -- Laminate Medical Technologies (Laminate) has announced their flagship device, the VasQ External Vascular Support, has been cleared by the FDA for use to create arteriovenous fistulas (AVFs) for dialysis access.
- TEL AVIV, Israel, Sept. 27, 2023 /PRNewswire/ -- Laminate Medical Technologies (Laminate) has announced their flagship device, the VasQ External Vascular Support, has been cleared by the FDA for use to create arteriovenous fistulas (AVFs) for dialysis access.
- No serious adverse event associated with the device was reported over the 2-year study.
- Additional analysis comparing VasQ patients against claims data for traditional AVFs created by the same surgeons in the study reported statistically superior rates of functional success (confirmed use of the AVF for dialysis) and reduced need for additional procedures.
- VasQ is a nitinol-based device implanted around the artery and vein during the surgical creation of an arteriovenous fistula.