“We can also load strontium, magnesium and zinc into the same matrix and control how much is eluted,” Johns said. hip and knee segments where infection prevention is more prevalent. DiFusion’s CleanFuse material, an antimicrobial PEEK, has CE Mark approval, and the company plans to first launch it in the U.S. The company’s patented process lends itself to development of bony ingrowth, antimicrobial and tissue regeneration polymers. In 1H18, the company plans to seek a strategic partner for ZFUSE. No other company can make that claim, says Johns.ĭiFusion Technologies, founded in 2010, describes itself as an advanced biomaterials manufacturer and not a device company. They expect to submit the data to FDA in January 2018 as part of a 510(k) submission that, once cleared, would give the company an osteoconductive and a biological fixation claim for their material. As the company’s President and CEO Derrick Johns says, they’ve merged the best qualities of titanium and PEEK to create ZFUSE.ĭiFusion Technologies recently invested $500,000 in a sheep study. Both expect to launch products in 2018.ĭiFusion Technologies added zeolite molecules to Solvay’s Zeniva ZA-500 PEEK to change the material to a negatively-charged substance that cultivates osteoconduction while preserving the polymer’s visualization, modulus and strength benefits. At NASS, we sat down with representatives from two companies, DiFusion Technologies and MiRus, that are taking different approaches to materials.
It could be a decade or more before new materials are proven through patient outcomes and surgeon adoption. Our conversations with surgeons and device companies lead us to restate that the materials space will spur innovation in spine. In short, this trend has been spurred by the desire for a material with greater strength and bone-ingrowth capabilities. Most device companies have responded to surgeon voices by launching cages made of titanium-coated PEEK, complete titanium, additively-manufactured titanium and even porous PEEK.
In response to spine surgeons’ shift away from traditional PEEK cages, materials were (again) one of the main themes discussed at the North American Spine Society Annual Meeting.
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