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# MicroVention PMA OK’d for Neck Aneurysm Device
- URL: https://www.fdaweb.com/microvention-pma-okd-for-neck-aneurysm-device/
- Published: 2019-01-07T12:00:00.000Z
- Updated: 2026-09-15T00:52:43.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143093

FDA has approved a MicroVention (a Terumo subsidiary) PMA for the WEB Aneurysm Embolization System for treating intracranial wide neck bifurcation aneurysms. The company says the device is the only PMA-approved device in the new category of intrasaccular flow disruptors for aneurysm embolization. PMA approval is based on data from the WEB-IT pivotal trial where the device demonstrated 84.6% adequate occlusion. The WEB System was developed by Sequent Medical, which Terumo acquired in 2016.  
  
The WEB System is a single-device treatment solution for wide neck bifurcation aneurysms, which may account for up to 35% of all aneurysms, according to the company. When placed inside the aneurysm sac, its proprietary microbraid technology is intended to bridge the aneurysm neck, disrupting blood flow, and creates a scaffold for long-lasting treatment, it explains.