FDA Premarket Approval (PMA) for the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms was announced today by MicroVention, Inc. The WEB System is the first and only PMA approved device in the new category of intrasaccular flow disruptors for aneurysm embolization. (The WEB System was developed by Sequent Medical, Inc. and Sequent was acquired by Terumo in 2016).
The WEB System is a unique, single-device treatment solution for wide neck bifurcation aneurysms, which may account for up to 35% of all aneurysms. When placed inside the aneurysm sac, the WEB device’s proprietary microbraid technology bridges the aneurysm neck, disrupting blood flow, and creates a scaffold for long-lasting treatment.
“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 embolization coils and assist devices,” noted Adam Arthur, MD, 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 pivotal WEB Intrasaccular Therapy Trial (WEB-IT) 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 Embolization 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.
“We are proud to offer our latest innovation to the neuroendovascular market in the United States with the introduction of the WEB System, achieving the most rigorous standard of FDA approval through the PMA process,” said Richard Cappetta, President and Chief Executive Officer of MicroVention. “At MicroVention, we work side-by-side with physicians to consistently deliver innovative technologies to advance patient care.”
“In the pivotal trial, patients benefited from the WEB System through a safe and effective treatment with excellent clinical outcomes, fast procedure times and limited radiation exposure. The WEB System is a first-to-market, innovative and highly studied intrasaccular solution that advances the treatment of wide neck bifurcation aneurysms,” said David Fiorella, MD, PhD, 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.