![]() ![]() I was beginning to believe that this was not possible,” said Badylak. “We have evaluated the immune response to biomaterials for more than 20 years and the ZFUZE is the first load bearing biomaterial we have seen that elicits a pro-reparative macrophage phenotype rather than a pro-inflammatory phenotype. One of the leaders in the field of immune response of biomaterials, Stephen Badylak, DVM, MD, PhD, Deputy Director of the McGowan Institute for Regenerative Medicine, conducted a third-party study on ZFUZE. The immune system plays a vital role in tissue healing, but only recently has the medical device industry understood the importance of the immune response in the design and development of implantable medical materials and devices. ![]() DiFusion will launch Xiphos ZFUZE in the spinal market in Q4 2019 and has plans to launch an ACL repair screw in early 2020 in the sports medicine market. Neither material was engineered specifically for orthopedic surgical procedures. Both titanium and PEEK were borrowed from the aerospace industry because of their strength and surface characteristics alone. Together, these materials make up the $2.1 billion in sales of spinal fusion interbody devices. “What sets this device apart is the biomaterial, ZFUZE, which is unlike any other orthopedic implant material on the market today.”Ĭurrently, the spinal fusion market is dominated by implants made of titanium and PEEK (poly-ether-ether-ketone) polymer. “The Xiphos implant utilizes a time-tested design already successfully implanted in human spinal surgeries,” said Sriram Sankar, VP of Research, DiFusion. IL1-Beta and IL6 are cytokine markers for prolonged inflammation and associated with fibrous tissue formation. Multiple studies have shown the ZFUZE material elicits pro-reparative M2 macrophage response and significant reductions in Interleukin 1-Beta and Interleukin 6. Xiphos-ZF is the first spinal implant developed from a new biomaterial called ZFUZE. today announced the FDA 510K clearance for the Xiphos-ZF Spinal interbody device. AUSTIN, Texas–(BUSINESS WIRE)–DiFusion, Inc. ![]()
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