ZFUZE is FDA approved in the USA.
Stephen Badylak, DVM, PhD, MD discusses the osteoimmunology of the breakthrough new surgical polymer ZFUZE.
ZFUZE™: Osseoconductive, no foreign body response which signals fibrous encapsulation.
Recent studies have now shown that an inert polymer is less favorable to basic titanium implants in that there is “fibrous encapsulation” of the PEEK implants because it is an inert material and the body sees it as foreign material (Rene Olivares-Navarrete et.al; SPINE 40, 6, 399-404). Surgeons have foregone the visualization and modulus of elasticity benefits of plain PEEK for a “negatively charged” surface of titanium.
Patient X-Ray: 72 Weeks
Patient X-Ray: 10 Weeks
Negatively charged, hydrophilic ceramic Zeolite as shown under SEM.
ZFUZE combines the best features of both the modulus of PEEK and healing of titanium. We are expecting it to basically be PEEK that fuses, because there’s only one thing wrong with PEEK – it doesn’t fuse – so we fix that.
*ACL screw not yet approved for use in USA.
CleanFuze is an antimicrobial polymer which elutes pure silver cations in a measured and dosed manner over several weeks post-operative. CleanFuze has achieved a six-log reduction 99.9999% versus MRSA in a Clinical Rabbit Study conducted at Clemson University. CleanFuze received a CE Mark in 2013 and is not yet cleared for use in the USA.
In the body, various metallic ions act as cofactors of enzymes and stimulate a chain of reactions associated with cell signaling pathways for tissue regeneration. Metallic Ions as Therapeutic Agents has become a focused area of research within Regenerative Medicine, the issue to date has been “controlling the release of these MITA’s in concentration and time of release”. ZFUZE is the ideal polymer to accurately “post-load” various combinations of MITA’s for bone growth, antimicrobial, and tissue engineering applications. Adding these MITA’s to the pro-healing M2 macrophage modulating ZFUZE platform puts DiFusion at the cutting edge of therapeutic polymer research.
ZFUZE is a patented PEEK Composite Polymer which is made by compounding various forms of negatively charged Zeolites into the PEEK polymer. This fundamentally changes the surface chemistry from inert as in PEEK to negatively charged as in titanium while preserving the visualization, modulus and strength benefits of PEEK.
Robin Young from Orthopedics This Month presents Sriram Sankar, MS Joe Crudden Ph.D., and Derrick Johns CEO of DiFusion with the Innovator of the Year Award at the North American Society Meeting in Los Angeles.
Deputy Director of the McGowan Institute for Regenerative Medicine at the University of Pittsburgh
Assistant Professor of Orthopedic Surgery & Fellowship Director at Indiana Spine Group, PC
The Singer Institute at Alleghany Medical
Professor of Orthopedics Yale Medical School
Chief of Spine, University of California Irvine