The GIZA, a New Vertebral Body Replacement from Eden Spine is 510(K) Cleared

Altamonte Springs, Florida – Eden  Spine  ( announced  today  that  its new generation corpectomy device, the GIZA™, is 510(k) cleared.

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 clearance of the GIZA™ by  the  FDA  is another milestone in the company’s life cycle. The GIZA™ is patented, trademarked, and CE Marked. 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    CE  Marked  spine technologies internationally.

Contact Information:

Guillaume Viallaneix, CEO

Tel: 407 900 9986

US Headquarters: Eden Spine, LLC377 Maitland Ave – Suite 1015 – Altamonte Springs FL 32701 – USA

International: Eden Spine Europe SA 41 rue du 31 Decembre – Geneva 1207 – Switzerland