Results from the trial were published in the online edition of the Journal of NeuroInterventional Surgery, the Aliso Viejo, Calif.-based company said.
The trial enrolled a total of 150 patients across 21 U.S. centers and six international centers, MicroVention said. The company touted that the trial met both its primary safety and effectiveness endpoint.
Data from the trial was used to support FDA premarket approval fo the system, which the company won earlier this year.
The WEB system is designed to provide a single device treatment option for the treatment of up to 35% of all brain aneurysms. The system features microbraid technology to bridge the aneurysm neck and disrupt blood flow while creating a scaffold for a long-lasting effect.
“The WEB-IT pivotal trial shows that the WEB System is an effective and extremely safe treatment for a subset of aneurysms that are challenging to treat with standard embolization coils and assist devices. None of the aneurysms treated with the WEB System in the trial had follow-up bleeding events,” principal investigator Dr. Adam Arthur of the Semmes Murphey Neurologic & Spine Institute said in a prepared statement.
“The results of the WEB-IT trial match the patient outcomes we’ve seen in the six other good clinical practice studies completed in Europe. I have seen the positive impact of this device in my clinical practice since it became available. The WEB provides a very safe and minimally invasive treatment option for many patients who might have otherwise required open surgical clipping of their aneurysm,” principal investigator Dr. David Fiorella of the Stony Brook University Cerebrovascular and Stroke Center said in a press release.
The Web device won CE Mark approval in the European Union in 2010. Terumo acquired the rights to the Web device when it paid $280 million for Sequent in July 2016.2010 with more than 6,000 cases performed throughout the world.
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