Eden Spine’s Giza Receives Clearance (Walter Eisner @ OTW)
Eden Spine LLC has received FDA 510(k) clearance for its new corpectomy device called the Giza.
The company announcement on February 2, states the device is an expandable titanium VBR (vertebral body replacement), with rotatable endplates that provide multiple angulation options by simple endplates rotation.
According to the company, the device is indicated for vertebral body tumors and anterior column fractures and work with the patient’s anatomy in a modular fashion. Each implant comes fully assembled, and offers multiple angulation options by quick and simple endplates rotation. Adjustment of the implant height is securely achieved in situ with a simple and reliable locking mechanism that maintains it in distraction and avoids compression. The device also features an open architecture to allow for bone growth.
“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.”
The device, according to company CEO Guillaume Viallaneix, is patented, trademarked, CE Marked, and now, FDA cleared. The Giza “enhances the company’s technological footprint and ideally positions Eden Spine for long-term growth,” added Viallaneix. The company’s objective is to have the Giza available clinically both in the U.S. and internally via a dedicated network of stocking distributors and strategic partners.
The company is privately held and headquartered in Florida, with a wholly owned subsidiary in Geneva, Switzerland. Its portfolio is composed of five proprietary technologies: the Wwlldisc Total Disc Replacement; the Perfx-2 Dynamic Stabilization System, the Wellex Interspinous Technology, the Giza VBR and the Numis Lumbar Plating System.