Terumo’s US subsidiary MicroVention has secured premarket approval (PMA) from the US Food and Drug Administration (FDA) for its Web aneurysm embolization system to treat intracranial wide neck bifurcation aneurysms.
The Web system is claimed to be first and only PMA approved device under the new category of intrasaccular flow disruptors for aneurysm embolization.
Sequent Medical, which was acquired by Terumo in 2016, developed the Web aneurysm embolization system.
The new system is a single-device treatment solution for wide neck bifurcation aneurysms, which is said to account for up to 35% of all aneurysms.
MicroVention president and CEO Richard Cappetta said: “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.
“At MicroVention, we work side-by-side with physicians to consistently deliver innovative technologies to advance patient care.”
Web device has been developed for use at the middle cerebral artery (MCA) bifurcation, internal carotid artery (ICA) terminus, anterior communicating artery (AComm) complex or basilar artery apex for the endovascular treatment of adult patients with saccular, wide neck, bifurcation intracranial aneurysms with dome diameter from 3mm to 10 mm and either neck size 4mm or greater or the dome-to-neck ratio is greater than one and less than two.
The Web device’s microbraid technology links the aneurysm neck and disrupting blood flow inside the aneurysm sac, and creates a scaffold for durable treatment.
MicroVention’s Web intrasaccular therapy trial (WEB-IT) showed the device’s efficacy and proved its ability in a single-device procedure for wide neck bifurcation aneurysms.
In 2010, the company secured CE mark approval for Web aneurysm embolization system, and has been used in over 6,000 cases and multiple clinical studies across the world.
Web-IT trial principal investigator Dr David Fiorella said: “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.”