WEB™ Embolization System Indications, Safety, and Warnings
See Instructions for Use for a complete list of warnings, precautions, and contraindications
Indications for Use
U.S.A.
The WEB™ Aneurysm Embolization System is indicated for use at the middle cerebral artery (MCA) bifurcation, internal carotid artery (ICA) terminus, anterior communicating artery (AComm) complex, or basilar artery apex for the endovascular treatment of adult patients with saccular, wide neck bifurcation intracranial aneurysms with dome diameter from 3 mm to 10 mm and either neck size 4 mm or greater or the dome-to-neck ratio is greater than 1 and less than 2.
The WEB™ Aneurysm Embolization System is contraindicated for patients with known bacterial infection that may interfere with or negatively affect the implantation procedure and patients with known hypersensitivity to nickel. For complete indications, contraindications, potential complications, warnings, precautions, and instructions, see instructions for use (IFU provided in the device).
Caution: Federal law restricts this device to sale by or on the order of a physician
Rx Only: Federal (USA) law restricts this device to sale by or on the order of a physician.
For Healthcare Professionals - WEB Embolization Device Update
Outside U.S.A. (OUS)
The WEB™ Aneurysm Embolization System is intended for the endovascular embolization of ruptured and unruptured intracranial aneurysms and other neurovascular abnormalities such as arteriovenous fistulae (AVF).
The WEB™ Aneurysm Embolization System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation.
The device should only be used by physicians who have undergone training in all aspects of the WEB™ Aneurysm Embolization System procedures as prescribed by Terumo Neuro.
Brazil & Canada
The WEB™ Aneurysm Embolization System is intended for the endovascular embolization of ruptured and unruptured intracranial aneurysms.
It is recommended for saccular intracranial aneurysms located at the basilar artery apex, posterior communicating artery, middle cerebral artery bifurcation, termination of the internal carotid artery, anterior communicating artery in a body/neck ratio ≥ 1 and intracranial wide-neck aneurysm with a neck size ≥ 4 mm or body/neck ratio < 2.
The device should only be used by physicians who have undergone training in all aspects of the WEB™ Aneurysm Embolization System procedures as prescribed by manufacturer.
Asian Markets: The products may not be approved in all regions. The orders will be taken only in the regions where the product is approved by local regulatory authorities, as required.
