Titan Spine is a surface technology company focused on titanium interbody fusion implants, and is experiencing successful results.
Titan Spine received FDA clearance for its next generation nanoLOCK Surface Technology in November 2014, making it the first FDA clearance for a spinal implant to include nanotechnology. This is just the latest in a long line of surface technology the company offers.
The nanoLOCK surface increases the amount of nano-scaled textures as compared to its current surface to up-regulate a statistically significant greater amount of osteogenic and angiogenic growth factors critical for bone growth and fusion.1 The surface is formed by a reductive process of the titanium, which eliminates the potential for delamination and particulate debris that can occur with devices with a PEEK-titanium interface.
"What we have learned is that there are very specific implant surface topographies, especially at the nano level, that generate the osteogenic and angiogenic responses necessary to drive bone growth required for a robust fusion," says Paul Slosar, MD, Chief Medical Officer for Titan Spine. Dr. Slosar reported on a study conducted by Barbara Boyan, PhD, Dean of the School of Engineering at Virginia Commonwealth University, comparing Titan Spine's titanium implants with PEEK implants and found the titanium implants can stimulate stem cells to behave differently by promoting bone formation instead of creating inflammation and fibrosis.
"Through this research, we are able to better understand how implant surface properties influence specific inflammatory micro-environment factors," said Dr. Boyan. "We found that the titanium alloy surface with a complex micron scale and submicron scale roughness promotes a cellular response that favors bone formation. Conversely, PEEK created an inflammation response that will more likely lead to fibrous tissue formation."
Kyle Colle, DO, has been practicing spine surgery for several years and was once an avid PEEK product user. He tried titanium implants a few years ago, however, and has never looked back.
"I utilized PEEK for many years and experienced a lot of subsidence and non-unions," says Dr. Colle. "You are depending on your autograft and other kickers, including bone morphogenetic protein, to promote fusion. But you never get a solid fusion onto PEEK no matter what you stuff it with. The whole interface between bone and PEEK never actually fuses."
As a result, Dr. Colle looked for other options. He first tried titanium interbody devices a few years ago and found it to be more "bone friendly."
"The Titan titanium devices have several benefits for the patient, including very little subsidence, the disc space is open and keeps the vertebral body from collapsing," says Dr. Colle. "Using the titanium spacers also reduced the posterior neck pain."
He has seen his patients improve with the titanium impacts and anecdotally achieve better outcomes than with PEEK implants. Since beginning to use titanium, he hasn't seen a pseudoarthrosis case.
"I've done revisions from other surgeons where I took out PEEK interbody spacers and found there were no fusions around the implants and then revised them with Titan titanium spacers," he says. "I've only seen one case where the titanium spacer backed out, and that's in two years of using them."
Titanium is quickly becoming the material of choice among spine surgeons, according to Dr. Colle.
"There is continued research and study of the interface between titanium and bone," says Dr. Colle. "I think it's going to become more widely accepted. The Europeans now can't get enough titanium and they don't want PEEK anymore. Titan's research shows titanium interbody spacers are osteogenic to promote stem cells to behave in a way that promotes bone growth."
There have been some companies updating their PEEK now with titanium spray. "They want to improve the PEEK with titanium, but I would say just to use implants like Titan's that are entirely titanium," says Dr. Colle. "If the titanium is what works, and engineering has made the product better, then surgeons should stick to that."
Titan Spine is currently conducting research to demonstrate the potential for particulate debris production associated with titanium-sprayed PEEK implants during implantation. The company is also performing studies to counter the long-held belief that the modulus of elasticity of PEEK allows it to resist subsidence more effectively than titanium interbody fusion devices. The research will soon be published and presented at spine society meetings.
Titan Spine is so confident in their interbody devices that they announced a warranty last year for a one-time, free replacement of any eligible Titan spine interbody fusion device if revision surgery is required for a non-union within five years of the warranty period. "Ultimately, the warranty demonstrates the significant confidence we have in our products and science validating our surface technology," says Titan Spine CEO Peter Ullrich, MD.
1Data on file at Titan Spine.