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J Neurointerv Surg. 2019 Sep;11(9):924-930. doi: 10.1136/neurintsurg-2019-014815. Epub 2019 Apr 16.

The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study.

Author information

1
Semmes-Murphey Neurologic and Spine Institute, Memphis, Tennessee, USA.
2
Neurosurgery, University of Tennessee Health Science Center, Memphis, Tennessee, USA.
3
Neurovascular and Neuroradiology Research Unit, Nuffield Department of Surgical Sciences, Oxford University, Oxford, Oxfordshire, UK.
4
Neurosurgery, Johns Hopkins University, Baltimore, Maryland, USA.
5
Private Koru Hospital, Ankara, Turkey, Ankara, Turkey.
6
National Institute of Clinical Neurosciences, Budapest, Budapest, Hungary.
7
Neuroradiology, Marmara Universitesi Egitim ve Arastirma Hastanesi, Istanbul, Turkey.
8
Neurosurgery, Brigham and Women's Hospital, Boston, Massachusetts, USA.
9
Interventional Neuroradiology, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA.
10
Neurology/Neurosurgery, University of Tennessee Health Science Center, Memphis, Tennessee, USA.
11
Radiology, Koru Hospital, Ankara, Turkey.
12
Private Office, Saruhan Cekirge, Ankara, Turkey.
13
Neuroradiology, John Radcliffe Hospital, Oxford, Oxfordshire, UK.
14
Stony Brook University Hospital, Stony Brook, New York, USA.

Abstract

INTRODUCTION:

The Woven EndoBridge Intrasaccular Therapy (WEB-IT) Study is a pivotal, prospective, single-arm, investigational device exemption study designed to evaluate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms.

METHODS:

One-hundred and fifty patients with wide-neck bifurcation aneurysms were enrolled at 21 US and six international centers. Angiograms from the index procedure, and 6-month and 1-year follow-up visits were all reviewed by a core laboratory. All adverse events were reviewed and adjudicated by a clinical events adjudicator. A data monitoring committee provided oversight during the trial to ensure subject safety.

RESULTS:

One-hundred and forty-eight patients received the WEB implant. One (0.7%) primary safety event occurred during the study-a delayed ipsilateral parenchymal hemorrhage-on postoperative day 22. No primary safety events occurred after 30 days through 1 year. At the 12-month angiographic follow-up, 77/143 patients (53.8%) had complete aneurysm occlusion. Adequate occlusion was achieved in 121/143 (84.6%) subjects.

CONCLUSIONS:

The prespecified safety and effectiveness endpoints for the aneurysms studied in the WEB-IT trial were met. The results of this trial suggest that the WEB device provides an option for patients with wide-neck bifurcation aneurysms that is as effective as currently available therapies and markedly safer.

TRIAL REGISTRATION NUMBER:

NCT02191618.

KEYWORDS:

aneurysm; blood flow; coil; device; magnetic resonance angiography

Conflict of interest statement

Competing interests: The principal investigators for the WEB-IT trial received institutional salary support for study-related activities. Investigators in the WEB-IT trial also received payment for proctoring cases within the context of the trial. ASA is a consultant for Balt, Johnson and Johnson, Leica, Medtronic, Microvention, Penumbra, Scientia, Siemens, and Stryker; receives research support from Microvention, Penumbra, and Siemens; and is a shareholder in Bendit, Cerebrotech, Endostream, Magneto, Marblehead, Neurogami, Serenity, Synchron, Triad Medical and Vascular Simulations outside the submitted work. AM is a consultant for Microvention/Sequent, Stryker Neurovascular, and Cerus outside the submitted work. ALC is a consultant for Medtronic, Microvention, and Stryker Neurovascular outside the submitted work. IS is a consultant for Medtronic and Sequent/Microvention outside the published work. IS is a consultant for Sequent/Microvention, Stryker, Medtronic, and Cerenovus outside the submitted work. DH is a consultant for Covidien/Medtronic and Microvention outside the submitted work and has received research support from Siemens. JEDA is a consultant for Medtronic, Penumbra, and Sequent outside the submitted work. LE is a consultant for Codman Neurovascular, Medtronic, MicroVention, Penumbra, Sequent, and Stryker outside the submitted work. SC is a consultant for Medtronic and Sequent/MicroVention outside the submitted work and is a stockholder in ELUM and NDI. JVB provided core laboratory services to Sequent through Oxford University during the conduct of this study and now acts as a consultant for MicroVention and Oxford Endovascular; he is a stockholder of Oxford Endovascular outside the submitted work. DF is a consultant for Balt, Marblehead, Medtronic, Stryker, Microvention, Stryker, Penumbra, and Cerenovus; receives research support from Cerenovus, Medtronic, Stryker, Siemens, Microvention, and Penumbra, and royalties from Codman; and is a stockholder for Marblehead, Neurogami, and Vascular Simulations outside the submitted work.

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