Reverse Medical said it won CE Mark approval in the European Union for its Barrel vascular reconstruction device.
The Barrel device is designed to be used with occlusive devices when treating intracranial aneurysms, according to a press release.
“The Barrel VRD represents our ongoing commitment as a neuro-endovascular technology innovation company. We plan to expand our clinical experience with the Barrel technology, and begin commercialization in Europe through a network of expert distributors by mid 2014. The Barrel design is simple and elegant, essentially reducing the neck size of wide-neck bifurcation aneurysms, enabling traditional coil embolization, a craft already mastered by the neuro interventionalist,” president & CEO Jeffrey Valko said in prepared remarks.
In October, Reverse Medical won both CE Mark approval and 510(k) clearance from the FDA for its ReVerse neurovascular microcatheter device.