MicroVention (Terumo) has received FDA premarket approval (PMA) for the WEB aneurysm embolisation system for the treatment of intracranial wide neck bifurcation aneurysms. A press release states that the WEB system is the first and only PMA-approved device in the new category of intrasaccular flow disruptors for aneurysm embolisation, adding that the system was developed by Sequent Medical and Sequent was acquired by Terumo in 2016.
The WEB system is a single-device treatment solution for wide neck bifurcation aneurysms. When placed inside the aneurysm sac, the WEB device’s proprietary microbraid technology is designed to bridge the aneurysm neck, disrupting blood flow and to create a scaffold for long-lasting treatment.
The press release reports that the WEB-IT (WEB intrasaccular therapy) trial demonstrated that the WEB system is effective in attaining positive long-term clinical results in a safe, single-device procedure for wide neck bifurcation aneurysms. The WEB aneurysm embolisation system has been CE marked since 2010 and has been safely used in more than 6,000 cases and multiple clinical studies throughout the world.
Adam Arthur (Semmes Murphey Neurologic & Spine Institute, University of Tennessee, Knoxville, USA), a principal Investigator of the WEB-IT trial, comments: “The WEB system provides a valuable alternative for the treatment of bifurcation aneurysms. 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 embolisation coils and assist devices.”
Richard Cappetta, president and CEO of MicroVention, states: “We are proud to offer our latest innovation to the neuroendovascular market in the USA with the introduction of the WEB System, achieving the most rigorous standard of FDA approval through the PMA process. At MicroVention, we work side-by-side with physicians to consistently deliver innovative technologies to advance patient care”.