Titan Spine, LLC is moving across the globe, spreading its technology and know-how. The company has just received separate registration approval from both the Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) to commercially market its full line of Endoskeleton interbody fusion devices.
Titan Spine on the Move in Australia, New Zealand, UK, Spain

And there is definitely a market for these products. According to an article in The New Zealand Herald (“Big increase in risky back opps, ” Martin Johnston, January 4, 2014), the number of patients who received state-funded spinal fusions has doubled from 2001-2011. And in Australia, privately performed spinal fusion procedures increased by 167% from 1997-2006 (ANZ Journal of Surgery, “Trends of spinal fusion surgery in Australia: 1997 to 2006, ” Harris, I.A. and Dao, A.T., November 2009).
Company president Kevin Gemas said in the June 25, 2014 news release, “The recent marketing authorization approvals in Australia and New Zealand are a significant milestone for Titan Spine as they effectively expand the availability of our Endoskeleton interbody fusion devices to four broad global markets, including the United States and the European Union. Entry into our two most recent markets underscores the increasing global adoption of our titanium implants that feature a unique surface technology designed to participate in the fusion process by upregulating the body’s own bone growth factors. We look forward to developing relationships with spine surgeons in these two countries, with the ultimate goal of providing patients with an option for faster and more robust fusion.”
The company has also announced that it has expanded use of its Endoskeleton line of interbody devices to the United Kingdom, where low back pain affects about one-third of adults (according to the National Institute for Health and Clinical Excellence. John Sutcliffe, M.D., founder of the London Spine Clinic, was the first to utilize Titan Spine’s innovative interbody fusion technology in the United Kingdom. The Endoskeleton line is also now available to patients in Spain.
“I am pleased to initiate use of Titan Spine’s Endoskeleton TAS interbody device and its specialized surface treatment, ” commented Dr. Sutcliffe in the June 19, 2014 news release. “It is my belief that surface technology is the next significant innovation for spinal fusions due to the ability to affect a cellular response that promotes a more favorable osteogenic environment as compared to PEEK polymer implants.”
Gemas added, “The growing demand and use of Titan products demonstrates the expanding recognition that our engineered surface technology can be used to promote an enhanced environment for bone growth and ultimately fusion. We look forward to continued adoption and building on this momentum to bring Endoskeleton devices to more physicians and patients throughout the European Union and beyond.”

Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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