MicroVention has announced the publication of the WEB-IT pivotal trial results in the online edition of the Journal of NeuroInterventional Surgery.
The WEB aneurysm embolisation system met its primary safety and effectiveness endpoints in this prospective, single-arm study of 150 patients conducted at 21 US and six international centres. The results of the study led to the premarket approval of the WEB system late last year by the US Food and Drug Administration (US FDA) in the USA for treatment of wide neck bifurcation aneurysms in the brain.
“The WEB-IT pivotal trial shows that the WEB system is an effective and extremely safe treatment for a subset of aneurysms that are challenging to treat with standard embolization coils and assist devices. None of the aneurysms treated with the WEB system in the trial had follow-up bleeding events,” stated Adam Arthur, director of Cerebrovascular & Endovascular Neurosurgery at Semmes Murphey Neurologic & Spine Institute, associate professor of Neurosurgery at University of Tennessee, and a principal investigator of the WEB-IT trial.
The WEB system provides a clinically-proven, single device treatment option that advances the treatment of up to 35% of all brain aneurysms. The system’s proprietary microbraid technology bridges the aneurysm neck to disrupt blood flow and creates a scaffold for a long-lasting effect. The WEB system has been CE marked since 2010 with more than 6,000 cases performed throughout the world.
“The results of the WEB-IT trial match the patient outcomes we have seen in the six other good clinical practice studies completed in Europe. I have seen the positive impact of this device in my clinical practice since it became available. The WEB provides a very safe and minimally invasive treatment option for many patients who might have otherwise required open surgical clipping of their aneurysm.” said David Fiorella, professor of Neurological Surgery and Radiology, Director of Neurointerventional Radiology, Stony Brook University Cerebrovascular and Stroke Center and a principal investigator of the WEB-IT trial.