ArtVentive’s Endoluminal Occlusion System Receives FDA Clearance

ArtVentive Medical Group has received US FDA 510(k) clearance for its new EOS-X Endoluminal Occlusion System. The ArtVentive Endoluminal Occlusion System – EOS-X – is indicated for arterial and venous embolization in the peripheral vasculature. EOS-X delivers immediate, precise, and permanent occlusion in vessels from 2-16 mm in diameter.

"We are excited to receive this pre-marketing clearance for EOS-X, which represents a significant milestone for our company and major advancement for millions of patients." said Bill Olson, Chief Executive Officer at ArtVentive. "EOS-X brings almost double the size range, lower crossing profile, and enhanced retrievability to the proven EOS family platform, and of course continues to deliver the instant, precise, and permanent occlusion that EOS is known for around the world."

ArtVentive President & CTO Leon Rudakov commented, "ArtVentive was founded out of clinical need for better embolization technology, and with a plan to build a platform of devices for embolization, interventional oncology, structural heart disease, and more. Over the past several years, EOS has been used in patients globally with excellent results. EOS-X represents a leap forward in capabilities and economic value, and builds on the foundation of our previous clinical experience."