Titan Spine: FDA Clearance for Endoskeleton TL

It’s a slam dunk for Titan Spine, LLC, which has just received clearance from the FDA to commercially release its Endoskeleton TL system, a spinal fusion system that utilizes a lateral approach. As noted by the company, the Endoskeleton TL represents the first lateral fusion device to feature surface technology that is designed to participate in the fusion process by creating an osteogenic response to the implant’s topography.

According to the company, the Endoskeleton TL device utilizes Titan’s proprietary roughened titanium surface technology which has been shown to upregulate the production of osteogenic and angiogenic factors that are critical for bone growth and fusion. In addition, the design of the TL device incorporates large windows and large internal volumes to allow for significant bone graft packing, clear CT and MRI imaging, desired bone graft loading, and the ability to pack additional bone graft material within the device following implantation.

Kade Huntsman, M.D., an orthopedic spine surgeon with the Salt Lake Orthopaedic Clinic in Salt Lake City, Utah, performed the first surgeries utilizing the Endoskeleton TL on July 9, 2014. In the July 14, 2014 news release he said, “I was extremely pleased with the performance of the system. For the first time, I was able to insert additional bone graft material in to a lateral device post-implantation, and the radiopaque nature of the TL made it extremely easy to place the device in the desired location. I am excited to offer the TL, and the benefits of its surface technology and design features, to my patients requiring lateral interbody fusion.”

Andrew Shepherd, vice president of marketing for Titan, told OTW, “We are proud to be the first company to launch a lateral interbody device that features surface technology. The fact that we work closely with biomaterial academic thought leaders in the design of our surface technology highlights that our interbody devices, including the TL, are rooted in science. And while design features are extremely important, we know that our patients primarily benefit from the response that their cells have to the surface topography and associated surface energy of our implants. Encouraging and hastening the body’s own natural healing process will always be our focus as we continue the development of next-generation surface technologies. I am proud and confident to proclaim that Titan Spine is the leader in surface technology for spinal implant applications.”