Nurami Medical wins FDA clearance for dural repair graft for neurosurgery

[Image from the Nurami Medical website]Nurami Medical announced that it received FDA 510(k) clearance for its electrospun, nanofiber-based ArtiFascia dura substitute.

The Haifa, Israel-based company plans to begin U.S. sales for the resorbable dural repair graft soon.

ArtiFascia assists in the process of replacing the dura mater — which protects the brain and cerebrospinal fluid (CSF) — in neurosurgery. It combines two layers of electrospun nanofibers that form biomimetic scaffolds and a non-porous barrier layer.

The dual-function structure promotes dural tissue regeneration and rapid healing through the scaffold. Meanwhile, the barrier layer addresses CSF leakage from suture holes and bacterial penetration.

Nurami said it designed ArtiFascia with a thickness similar to the native dura for effortless suturing, accelerating surgeon workflow and lowering costs. The strong, pliable, fully absorbable, synthetic implant also offers ease in handling and cu…

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