FDA approval granted for Eden Spine’s Sphynx

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Sphynx
Sphynx antero-lateral thoraco-lumbar plating system (Eden Spine)

Eden Spine’s Sphynx plating system has been granted FDA clearance, the company has announced.

Sphynx was designed to complement the company’s Giza titanium vertebral body replacement with rotatable endplates, introduced in 2012. The Giza is intended to replace and fuse a collapsed, damaged, or unstable vertebral body due to a tumour or a fracture and provides multiple angulation options by rotating the endplates.

Made of titanium, the low-profile Sphynx is designed to be implanted via the antero-lateral approach for the treatment of thoraco-lumbar instabilities. Indications include spinal fractures, vertebral tumours, secondary instabilities of the thoracic and thoraco-lumbar spine, and any other indication requiring an anterior stabilisation low profile.

“The Sphynx is the latest innovation coming from our research and development department in Geneva, Switzerland,” says Ben Mokhtar, president of Eden Spine Europe, in a prepared statement. “Our goal was to develop a technology that was simple to use, intuitive, and worked with the anatomy. To achieve that goal, we have developed a cutting-edge integrated locking system, minimised the thickness of the implant in an effort to respect the surrounding tissues, and maximised the range of pre-curved plates, to provide optimal adaptation to patient’s anatomy.”

The Sphynx was granted CE Mark approval in 2016.

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