Sam Brusco, Associate Editor08.22.23
Israeli startup Nurami Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance or its ArtiFascia dura substitute, an electrospun nanofiber-based product, for use as a resorbable Dural repair graft.
For neurosurgeries needing Dura Mater replacement, ArtiFascia combines two layers of electrospun nanofibers, which form biomimetic scaffolds and a non-porous barrier layer. The scaffolds were engineered to promote dural tissue regeneration and quick healing, and the barrier layer addresses cerebrospinal fluid (CSF) leakage from suture holes and bacteria.
ArtiFascia has similar thickness to native dura, according to Nurami. It can be easily sutured to boost workflow and lower costs. The company said the implant is strong, pliable, fully absorbable, synthetic, and easy to handle and cut.
The FDA nod was supported by an 85-patient clinical trial that demonstrated “excellent performance” against the primary endpoints of CSF leakage prevention and other safety and surgeon preferences measures.
"This is an important milestone in Nurami's efforts to modernize soft tissue repair," Hannoch Marksheid, Nurami's co-CEO told the press. "ArtiFascia is a novel alternative for Dura repair, addressing dangerous CSF leaks and infections at the surgical site, while promoting Dura regeneration."
Prof. Andrew Kaye, neurosurgeon at the Hadassah Hebrew University Hospital Jerusalem, and former Professor and Director of neurosurgery at The Royal Melbourne Hospital, added, "There is a need for a thin, pliable Dural substitute that can be sutured in place, does not leak through the suture holes and that will integrate into the surrounding Dura." With regard to ArtiFascia, "Nurami's ArtiFascia Dura Substitute has exactly these features and showed impressive results in a clinical study. The presence of electropun nanofibers in the implant has the potential to be a game changer in optimizing Dural regeneration after neurosurgery."
For neurosurgeries needing Dura Mater replacement, ArtiFascia combines two layers of electrospun nanofibers, which form biomimetic scaffolds and a non-porous barrier layer. The scaffolds were engineered to promote dural tissue regeneration and quick healing, and the barrier layer addresses cerebrospinal fluid (CSF) leakage from suture holes and bacteria.
ArtiFascia has similar thickness to native dura, according to Nurami. It can be easily sutured to boost workflow and lower costs. The company said the implant is strong, pliable, fully absorbable, synthetic, and easy to handle and cut.
The FDA nod was supported by an 85-patient clinical trial that demonstrated “excellent performance” against the primary endpoints of CSF leakage prevention and other safety and surgeon preferences measures.
"This is an important milestone in Nurami's efforts to modernize soft tissue repair," Hannoch Marksheid, Nurami's co-CEO told the press. "ArtiFascia is a novel alternative for Dura repair, addressing dangerous CSF leaks and infections at the surgical site, while promoting Dura regeneration."
Prof. Andrew Kaye, neurosurgeon at the Hadassah Hebrew University Hospital Jerusalem, and former Professor and Director of neurosurgery at The Royal Melbourne Hospital, added, "There is a need for a thin, pliable Dural substitute that can be sutured in place, does not leak through the suture holes and that will integrate into the surrounding Dura." With regard to ArtiFascia, "Nurami's ArtiFascia Dura Substitute has exactly these features and showed impressive results in a clinical study. The presence of electropun nanofibers in the implant has the potential to be a game changer in optimizing Dural regeneration after neurosurgery."