BraidE Embolization Assist Device

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 categoryTemporary Embolization Assist Device, Peripheral

Device ID07290015107372

AvailabilityPrescription

Single useYes

SterileYes

MRI safetyLabeling does not contain MRI Safety Information