Device typeBare-metal intracranial vascular stent: A non-bioabsorbable tubular device typically intended to be implanted into the base or parent artery of an intracranial aneurysm (e.g., wide-neck aneurysm situated at the base of a bifurcation) to facilitate the delivery of embolics to fill the aneurysm, facilitate clotting within the aneurysm by slowing blood flow into it, and/or to provide support for a neurovascular embolization coil placed inside the aneurysm. It is made of uncoated metal [e.g., nickel-titanium alloy (Nitinol)]; it does not include a polymer tube (i.e., not a stent-graft). Disposable devices associated with implantation (e.g., balloon catheter) may be packaged with the stent.
FDA categoryIntracranial aneurysm flow diverter
Device ID07613327582604
Catalog numberFDSE32514
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional
Length14.0 Millimeter
Lumen/Inner Diameter3.25 Millimeter