FDA Grants Eden Spine 510(K) Clearance for its New Vertebral Body Replacement.

FDA Grants Eden Spine 510(K) Clearance for its New Vertebral Body Replacement.

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Altamonte Springs, Florida – Eden Spine (www.EdenSpine.com) announced today that it has received FDA 510(k) clearance for its new generation corpectomy device, the GIZATM.

The GIZATM is an expandable titanium VBR, with rotatable endplates, that provide multiple angulation options by simple endplates rotation. It is intended to replace and fuse a collapsed, damaged, or unstable vertebral body due to a tumor or a fracture.

Its beauty is its simplicity” said Mourad Ben Mokhtar, head of Eden Spine’s R&D efforts. He added “What we did with the GIZATM is to create an intuitive spinal system designed to help the surgeon easily implant the device, swiftly adapting its height and its angulation to the patient’s characteristics, hence maximizing the chances of a positive clinical outcome.”

For Guillaume Viallaneix, Eden Spine’s CEO, “The approval of the GIZATM by the FDA is another milestone in the company’s life cycle. The GIZATM is patented, trademarked, CE Marked, and FDA approved. It enhances the company’s technological footprint and ideally positions Eden Spine for long-term growth. A key 2012 objective is to have the GIZATMavailable clinically both in the United States and Internationally via a dedicated network of stocking distributors and strategic partners.”

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Eden Spine LLC is a privately held, technology driven, spinal organization. The Eden Spine Group is headquartered in Florida, with a wholly owned subsidiary in Geneva, Switzerland. It is currently developing and distributing a range of new generation spinal technologies. Eden Spine is present in the United States, Europe, the Middle East and Latin America. The company portfolio is currently composed of 5 proprietary technologies; the WELLDISCTM Total Disc Replacement; the PERFX-2TMDynamic Stabilization System, the WELLEXTM Interspinous Technology, the GIZATM VBR and the NUMISTM Lumbar Plating System. Eden Spine currently possesses a range of FDA-cleared and CE Marked spine technologies in the US and internationally.

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