Clinical trial results published in the online edition of the Journal of Neurointerventional Surgery showed positive clinical outcomes for an aneurysm embolization system (Web aneurysm embolization system; MicroVention, Aliso Viejo, CA) that bridges the aneurysm neck to disrupt blood flow and create a scaffold for a long-lasting effect.
The system met its primary safety and effectiveness endpoints in the WEB-IT trial (NCT02191618), a prospective, single-arm study of 150 participants. This device is indicated for use at the middle cerebral artery (MCA) bifurcation, internal carotid artery (ICA) terminus, anterior communicating artery complex, or basilar artery apex for the endovascular treatment of adults. The system can be used with saccular wide-neck bifurcation intracranial aneurysms with dome diameter from 3 mm to 10 mm, neck size 4 mm or greater, or a dome-to-neck ratio greater than 1 and less than 2.
The results of the study led to the Premarket Approval (PMA) of the system last year by the Food and Drug Association (FDA) for treatment of wide-neck bifurcation aneurysms in the brain.
“The results of the WEB-IT trial match the patient outcomes we’ve seen in the 6 other good clinical practice studies completed in Europe,” said David Fiorella, MD, PhD, professor of neurological surgery and radiology, director of neurointerventional radiology, Stony Brook University Cerebrovascular and Stroke Center. “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.”
Robert Shavelle, PhD, FAACPDM; Jordan Brooks, PhD, MPH; David Strauss, PhD, FASA; and Amytis Towfighi, MD
James Geyer, MD, and Jenna Cooper, CRNP
Mark B. Skeen, MD