This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Woven EndoBridge (WEB) Aneurysm Embolization System
PMA Applicant: Sequent Medical, Inc.
Address: 11A Columbia Street, Aliso Viejo, CA 92656
Approval Date: December 31, 2018
Approval Letter: Approval Order
What is it? The Woven EndoBridge (WEB) Aneurysm Embolization System is a permanent nitinol (nickel titanium) self-expanding mesh ball implant for the treatment of wide-neck intracranial aneurysms located at or near branching areas of arteries in the brain. The device system consists of the implant, the delivery wire, and the controller that is used to detach the device from the delivery wire.
How does it work? The WEB Aneurysm Embolization System is introduced into the blood vessels typically near the groin region. The WEB implant is then detached from the delivery system and placed into the sac of the intracranial aneurysm. The WEB implant is designed to disrupt blood flow entering the aneurysm and help promote clotting (thrombosis).
When is it used? The WEB Aneurysm Embolization System is indicated for use in the following arteries located in the brain (middle cerebral artery (MCA) bifurcation, internal carotid artery (ICA) terminus, anterior communicating artery (AComm) complex, or basilar artery apex) for the 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.
What will it accomplish? The WEB Aneurysm Embolization System may reduce blood flow into the aneurysm.
In a clinical study of 150 subjects in which treatment with the device was attempted, 54.77% of subjects met the primary effectiveness endpoint and achieved a successful treatment (complete occlusion) of their intracranial aneurysm within 1-year post-procedure without re-treatment, recurrent subarachnoid hemorrhage, or clinically significant parent artery stenosis.
When should it not be used? The WEB Aneurysm Embolization System should not be used in patients with known:
- Active bacterial infection that may interfere with or negatively affect the implantation procedure.
- hypersensitivity to nickel.
Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data (SSED) and labeling are available online.