Postmarket American Experience With Woven EndoBridge Device: Adjudicated Multicenter Case Series

BACKGROUND: The Woven EndoBridge (WEB) device was granted premarket approval in the United States following results of the Woven EndoBridge Intrasaccular Therapy (WEB-IT) study. WEB-IT reported excellent adequate angiographic occlusion of treated aneurysms with a high safety profile. These results were achieved, however, in the context of a prospective study with strict inclusion criteria and rigorous training support. OBJECTIVE: To review early as-practiced clinical experience with the WEB device in the United States. METHODS: Retrospective review across 6 institutions identified 91 patients undergoing 92 treatment sessions for WEB device placement in treatment of 91 intracranial aneurysms. Details regarding demographics, aneurysm characteristics, treatment considerations, clinical outcomes, and aneurysm occlusion were obtained and analyzed in a multicenter database. Angiograms from the index procedure and follow-up studies were reviewed by a blinded and independent adjudicator. RESULTS: The middle cerebral, anterior communicating, and basilar artery complexes were the commonly treated locations. Eight patients presented with ruptured aneurysms. A mean of 1.2 devices were introduced per case. Technical failure without deployment of a WEB device occurred in 2% (2/92) of sessions. Complete aneurysm occlusion for patients with imaging follow-up was 49% (mean follow-up of 8 mo). Four aneurysms were retreated. 90% of patients had modified Rankin Scale <= 2 at last clinical follow-up with no mortalities. CONCLUSION: Immediate postmarket experience with the WEB device, newly introduced at American centers, confirms safe procedural use, but long-term efficacy remains unclear. Early challenges include accurate sizing and device selection.

Automated summary

Review of early clinical experience with the WEB device in the United States showed safe procedural use with challenges including accurate sizing and device selection. The study identified commonly treated locations for the device and reported a 49% complete aneurysm occlusion rate during imaging follow-up. Long-term efficacy remains uncertain while immediate postmarket experience confirms safety.