Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention said today that it won pre-market approval from the FDA for the Web brain aneurysm device it acquired when it bought Sequent Medical back in 2016.
Aliso Viejo, Calif.-based MicroVention said the PMA for the Web embolic coil covers the treatment of intracranial wide neck bifurcation aneurysms.
“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,” MicroVention president & CEO Richard Cappetta said in prepared remarks. “At MicroVention, we work side-by-side with physicians to consistently deliver innovative technologies to advance patient care.”
“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,” added Dr. Adam Arthur, of Tennessee’s Semmes Murphey Neurologic & Spine Institute, who was a principal investigator for the study.
“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 Dr. David Fiorella, another principal investigator at New York’s Stony Brook University Cerebrovascular & Stroke Center.
The Web device won CE Mark approval in the European Union in 2010. Terumo paid $280 million for Sequent in July 2016.
