FDAnews Device Daily Bulletin

Reverse Medical Gets CE Mark for Barrel Device for Intracranial Aneurysms

Dec. 24, 2013

European device regulators have granted Reverse Medical CE Mark approval for its Barrel vascular reconstruction device for the treatment of intracranial aneurysms. The Calif.-based devicemaker plans to make the device commercially available in Europe by mid-2014.

Reverse Medical’s Barrel technology reduces the neck size of wide-neck bifurcation aneurysms, making traditional coil embolization easier, and is designed to move easily through difficult anatomy, the company says. The device also has good visibility, is resheathable requires no radial orientation maneuvers in order to be accurately inserted, the devicemaker adds.

In October, Reverse Medical earned a CE mark and FDA 510(k) clearance for its ReVerse neurovascular microcatheter. — Lena Freund