Altamonte Springs, FL, February 02, 2012 --(PR.com)-- Eden Spine (www.EdenSpine.com) announced today that it has received FDA 510(k) clearance for its new generation corpectomy device, the GIZA™.
The GIZA™ 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 GIZA™ 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 GIZA™ by the FDA is another milestone in the company’s life cycle. The GIZA™ 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 GIZA™ available clinically both in the United States and Internationally via a dedicated network of stocking distributors and strategic partners.”
About Eden Spine:
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 WELLDISC™ Total Disc Replacement; the PERFX-2™ Dynamic Stabilization System, the WELLEX™ Interspinous Technology, the GIZA™ VBR and the NUMIS™ Lumbar Plating System. Eden Spine currently possesses a range of FDA-cleared and CE Marked spine technologies in the US and internationally.
Eden Spine, LLC
377 Maitland Ave - Suite 1015
Altamonte Springs FL 32701
Eden Spine Europe SA
41 rue du 31 Decembre
Eden Spine, LLC
Contact via Email
Click here to read the full story: FDA Grants Eden Spine 510(K) Clearance for Its New Vertebral Body Replacement
Press Release Distributed by PR.com
Nasdaq quotes delayed at least 15 minutes, all others at least 20 minutes.
Markets are closed on certain holidays. Stock Market Holiday List
By accessing this page, you agree to the following
Press Release Service provided by PRConnect.
Stock quotes supplied by Six Financial
Postage Rates Bots go here