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CE mark approval, initial clinical use

Manufacturing Group | December 30, 2013

Reverse Medical’s BARREL vascular reconstruction device for the treatment of intracranial bifurcation aneurysms gets the nod.

Reverse Medical Corp. officials announced the CE Mark approval for European commercialization of their BARREL Vascular Reconstruction Device (VRD) and the first European clinical case. The BARREL Vascular Reconstruction Device is intended for use with occlusive devices in the treatment of intracranial aneurysms.

“Our first experience with the BARREL VRD in a wide-neck bifurcation intracranial aneurysm was impressive. The device tracked easily through tortuous anatomy, had excellent angiographic visibility, was easily and completely re-sheathable, and deployed very nicely. The device required no radial orientation maneuvers for accurate placement, providing a single device alternative to surgery, or to technically challenging 'X-Y' stenting for these complex bifurcation aneurysms,” stated Michel Piotin, MD, PhD, Director, Department of Interventional Neuroradiology, Fondation Rothschild Hospital, Paris, France. Rafael Blanc, MD added, “I expect the BARREL to become an important tool in our practice.”

Reverse Medical President and CEO Jeffrey Valko commented, “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.”

Source: Reverse Medical Corp.

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