New Aneurysm Treatment Device Receives Premarket Approval

 

The Food and Drug Administration (FDA) granted premarket approval (PMA) to an intrasaccular flow disruptor (Web aneurysm embolization system; Microvention, Aliso Viejo, CA) which is a single-device treatment for wide-neck bifurcation aneurysms that account for up to 35% of all aneurysms. This is the first intrasaccular flow disruptor approved for aneurysm embolization.

"The WEB System provides a valuable alternative for the treatment of bifurcation aneurysms,” said Adam Arthur, MD, Director of Cerebrovascular & Endovascular Neurosurgery at Semmes Murphey Neurologic & Spine Institute and Associate Professor of Neurosurgery at the University of Tennessee. “In the WEB-IT pivotal trial, the WEB System demonstrated 84.6% adequate occlusion and an extraordinary safety profile for a subset of aneurysms that are challenging to treat with standard embolization coils and assist devices." 

When placed inside the aneurysm sac, the intrasaccular flow disruptor bridges the aneurysm neck to disrupt blood flow and create a scaffold for long-lasting treatment. The device is indicated for endovascular treatment of adult patients at the middle cerebral artery bifurcation, internal carotid artery terminus, anterior communicating artery complex, or basilar artery apex.    

The WEB-IT trial (NCT02191618) demonstrated that this intrasaccular flow disruptor is effective in attaining positive long-term clinical results in a safe, single-device procedure. The system has been safely used in more than 6,000 cases and multiple clinical studies worldwide.

 

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