PR Web08.31.18
The U.S. Food and Drug Administration has granted Eden Spine 510(k) clearance for its vertebral body replacement implant, SPHYNX.
SPHYNX is the ideal complement to Eden Spine proprietary, expandable titanium vertebral body replacement implant with rotatable endplates, the GIZA which provides multiple angulation options by simple endplates rotation. The GIZA is intended to replace and fuse a collapsed, damaged, or unstable vertebral body due to a tumor or a fracture.
Made of titanium, the low-profile SPHYNX is to be implanted via the antero-lateral approach for the treatment of thoraco-lumbar instabilities. Indications include spinal fractures, vertebral tumors, secondary instabilities of the thoracic and thoraco-lumbar spine, and any other indication requiring an anterior stabilization low profile.
“The SPHYNX is the latest innovation coming from our R&D department in Geneva, Switzerland,” said Ben Mokhtar, president of Eden Spine Europe SA. “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, minimized the thickness of the implant in an effort to respect the surrounding tissues, and maximized the range of precurved plates, to provide optimal adaptation to patient’s anatomy.”
The SPHYNX was granted CE Mark approval in 2016.
Eden Spine is a privately held, technology driven spinal organization based in Switzerland since 2005. The company distributes a range of spinal technologies in the United States and abroad. Eden Spine patented portfolio is composed of a mix of fusion and non-fusion technologies.
SPHYNX is the ideal complement to Eden Spine proprietary, expandable titanium vertebral body replacement implant with rotatable endplates, the GIZA which provides multiple angulation options by simple endplates rotation. The GIZA is intended to replace and fuse a collapsed, damaged, or unstable vertebral body due to a tumor or a fracture.
Made of titanium, the low-profile SPHYNX is to be implanted via the antero-lateral approach for the treatment of thoraco-lumbar instabilities. Indications include spinal fractures, vertebral tumors, secondary instabilities of the thoracic and thoraco-lumbar spine, and any other indication requiring an anterior stabilization low profile.
“The SPHYNX is the latest innovation coming from our R&D department in Geneva, Switzerland,” said Ben Mokhtar, president of Eden Spine Europe SA. “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, minimized the thickness of the implant in an effort to respect the surrounding tissues, and maximized the range of precurved plates, to provide optimal adaptation to patient’s anatomy.”
The SPHYNX was granted CE Mark approval in 2016.
Eden Spine is a privately held, technology driven spinal organization based in Switzerland since 2005. The company distributes a range of spinal technologies in the United States and abroad. Eden Spine patented portfolio is composed of a mix of fusion and non-fusion technologies.