April 16, 2019
Final Results Published From Pivotal Trial of MicroVention's WEB System
April 17, 2019—The final 12-month results of the pivotal trial for the Woven EndoBridge (WEB) system (MicroVention, Inc.) were published by Adam S. Arthur, MD, et al online ahead of print in Journal of NeuroInterventional Surgery (JNIS).
The 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.
In January 2019, MicroVention, a United States–based subsidiary of Terumo, announced FDA premarket approval for the WEB aneurysm embolization system for the treatment of intracranial wide-neck bifurcation aneurysms. The WEB system is an intrasaccular flow disruptor for aneurysm embolization. The device was developed by Sequent Medical, Inc., which was acquired by Terumo in 2016.
As summarized in JNIS, the WEB-IT study was composed of 150 patients with wide-neck bifurcation aneurysms who were enrolled at 21 centers in the United States and six international centers. A core laboratory reviewed angiograms from the index procedure and at 6-month and 1-year follow-up visits. A clinical events adjudicator reviewed and adjudicated all adverse events. A data monitoring committee provided oversight during the trial to ensure patient safety.
From the 148 patients who received the WEB implant, the investigators reported the following:
- One (0.7%) primary safety event—a delayed ipsilateral parenchymal hemorrhage on postoperative day 22—occurred during the study
- No primary safety events occurred at 30 days through 1 year
- Twelve-month angiographic follow-up showed that 77/143 (53.8%) patients had complete aneurysm occlusion
- Adequate occlusion was achieved in 121/143 (84.6%) patients at 12-month follow-up
By meeting the prespecified safety and effectiveness endpoints for the aneurysms studied in the WEB-IT trial, the results 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, concluded the investigators in JNIS.