12.31.13
In late December, Reverse Medical Corp. received CE Mark approval for European commercialization of its Barrel vascular reconstruction device (VRD) and reported 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, M.D., Ph.D., director of the Department of Interventional Neuroradiology at Fondation Rothschild Hospital in Paris, France.
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."
In October, that company received CE mark approval and 510(k) clearance from the U.S. Food and Drug Administration for its ReVerse neurovascular microcatheter device.
Reverse Medical is a privately held medical device company based in Irvine, Calif., focused on expanding the endovascular management of acute stroke, neuro and peripheral vascular disease.
"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, M.D., Ph.D., director of the Department of Interventional Neuroradiology at Fondation Rothschild Hospital in Paris, France.
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."
In October, that company received CE mark approval and 510(k) clearance from the U.S. Food and Drug Administration for its ReVerse neurovascular microcatheter device.
Reverse Medical is a privately held medical device company based in Irvine, Calif., focused on expanding the endovascular management of acute stroke, neuro and peripheral vascular disease.