MicroVention’s WEB 17 Aneurysm Embolization System Evaluated in European CLEVER Study

July 23, 2024—MicroVention, Inc., a neurovascular company and wholly owned subsidiary of Terumo Corporation, announced the publication of the results of the CLEVER trial.

The multicenter, prospective study was composed of 163 patients enrolled at 17 centers in Europe. The investigators evaluated the safety and effectiveness of the company’s Woven EndoBridge (WEB) 17 system in ruptured and unruptured aneurysms. The device is MicroVention’s newest and smallest WEB aneurysm embolization system.

According to the company, the CLEVER study concluded that WEB 17 is as safe and effective as previous WEB generations with a low complication rate and no rebleeds at 30 days and 1 year of follow up. The press release noted that the adequate occlusion rate was 86.5% for ruptured aneurysms (73.1% complete occlusion) and 82.4% for unruptured aneurysms (57.1% complete occlusion) at 1 year.

The findings from the CLEVER study were published by Professor Laurent Spelle, MD, et al online in Journal of NeuroInterventional Surgery.

“One-year angiographic results of CLEVER show excellent complete occlusion rates at one year in the population of wide neck bifurcation aneurysms treated with WEB 17,” commented Prof. Spelle in the company’s press release. Prof. Spelle is Chairman at NEURI Brain Vascular Center, Bicêtre Hospital, APHP, Paris-Saclay University in Paris, France.

MicroVention stated that the WEB embolization system’s intrasaccular technology offers a single-device solution for wide neck bifurcation aneurysms. The system minimizes the need for a dual-antiplatelet regimen required for intraluminal therapies.

In January 2019, MicroVention announced the initial FDA premarket approval for the first WEB aneurysm embolization system.

The company noted it is marking the fifth anniversary of the introduction of the WEB system by showcasing the device along with its entire line of products at the Society of NeuroInterventional Surgery’s 21st annual meeting held July 22-26 in in Colorado Springs, Colorado.

“WEB has changed my practice and set a new standard for safety in the treatment of cerebral aneurysms,” stated Adam Arthur, MD, in the press release. Dr. Arthur is James T. Robertson Professor and Chair at The University of Tennessee Health Science Center in Memphis, Tennessee. He served as principal investigator for the WEB-IT trial, which was the United States investigational device exemption study to support premarket approval of the WEB in the United States.