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SpineVision wins FDA nod, CE Mark for titanium TLIF cage

September 20, 2018 By Danielle Kirsh

spinevision-logoSpineVision recently announced that it has received FDA clearance and CE Mark approval for its titanium 3D laser-printed Hexanium TLIF cage for back surgery.

Spine fusion surgery is used to stop the motion of a painful segment in the spine by fusing two of the vertebrae with a TLIF cage. The procedure is used to treat conditions like tumors, spinal stenosis, herniated discus and degenerative disc disease.

“Hexanium TLIF is an advance for spine fusion surgery,” said neurosurgeon Dr. Gary Colon. “I am able now to deploy the TLIF cage exactly where my intent is when I start the approach. And that’s been a big move forward compared to prior products that I used.”

SpiveVision’s Hexanium TLIF cage uses a roughened titanium surface that is designed for fast osseointegration along with a honeycomb-like structure. It features large windows for maximizing bone in-growth and on-growth from each endplate.

“While TLIF back surgery is successful at relieving patients’ pain in about 60 to 70% of cases, there is room for improvement,” Arnaud Brisard, CEO of SpineVision, said in a press release. “In particular, our Hexanium TLIF cage is designed to reduce the risk of subsidence in disc height in the post-operative period. Hexanium represents a continuation of our substantial achievements in developing cutting-edge products for all spine pathologies. Hexanium TLIF is the first of a complete range of 3D-printed implants SpineVision will be introducing.”

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