ANTONY, France–(BUSINESS WIRE)–SpineVision announced today that it has received FDA clearance and CE mark for its next-generation titanium 3D laser-printed HEXANIUM TLIF (Transforaminal Lumbar Interbody Fusion) cage for back surgery. SpineVision will introduce its new product to spine surgeons at “EuroSpine 2018” (Booth #24C) in Barcelona, Spain (Sept. 19-21), and “NASS 2018” (Booth #1311) in Los Angeles (Sept. 26-29).
Spine fusion surgery is often necessary to stop the motion of a painful segment in the spine by fusing two vertebrae with a TLIF cage. Conditions that may be treated with a spine fusion include tumors, spinal stenosis, herniated discs, and degenerative disc disease. The HEXANIUM TLIF cage combines a roughened titanium surface designed for fast osseointegration along with a honeycomb-like structure that features large windows for maximizing bone in-growth and on-growth from endplate to endplate.
“While TLIF back surgery is successful at relieving patients’ pain in about 60 to 70 percent of cases, there is room for improvement,” said Arnaud Brisard, CEO of SpineVision. “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.”
“Hexanium TLIF is an advance for spine fusion surgery,” said Neurosurgeon Gary P. Colon, M.D., NCH Healthcare System, Naples, Fla. (Click here for an interview with Dr. 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.”
The titanium 3D laser-printed HEXANIUM TLIF features a rough surface designed for strong primary integration; along with maximized porosity designed for optimal bone in-growth and on-growth from endplate to endplate:
Spine fusions are unique among all surgical procedures because they are the only type of surgery in which the goal is to hold two bones apart while encouraging them to grow back together. The bones being held apart and fused together are the two vertebrae at the affected level. A “cage” is placed in the interbody space and packed with bone graft to help stimulate bone growth. It restores the height of the spine and stabilizes the vertebrae as they fuse together.
In a successful fusion, the bone grows around and through the cage over time, making it the only place in the body where a material is implanted and active in the reparative process. In other words, the cage and the material it is made out of play an active role in the growth of the bone that forms the fusion. Titanium cages with a nanotechnology surface favor factors that are associated with an anti-inflammatory response and the formation of bone. (source: www.spine-health.com) SpineVision, headquartered near Paris, is a global spine company with a successful track record of commercializing innovative products addressing all spine pathologies.
The Company has direct sales operations in Europe (Italy, France, Belgium, Germany, UK, Ireland), the United States and Canada. Additionally, SpineVision’s products are distributed in Latin America (Brazil, Peru, Chile, Mexico and Columbia), Europe (Switzerland, Greece and Bulgaria), and the MEA (Israel, Egypt and UAE).