The Immune Response Question
Inert materials like titanium and PEEK implants can be viewed as a foreign body by the patient’s immune system and, when that happens, clinicians have noticed “fibrous encapsulation” around the implant. Would ZFUZE have the same outcome?
The researchers performed a comprehensive histology and immunochemistry battery on both ZFUZE and PEEK alone.
Result (see table below) minimal response to ZFUZE, but prolonged inflammatory immune response at 26 weeks for “plain PEEK.”
|
ZFUZE vs. PEEK in a 12, 26-week Sheep Model |
|
|
PEEK at 12 WEEKS: “For the first 12 weeks, the plain PEEK shows relatively little bone formation around the graft early and more bone but no real bridging late, as well as development of a fibrous layer around the implant. This what we see clinically as well. There is also a lot of erosion of the endplates around the graft, suggesting excess motion.” |
 |
 |
|
|
ZFUZE at 12 WEEKS: “In the ZFUZE slides we saw clear bone formation early and bridging late. We did not see fibrous layer development around the implant.” |
 |
 |
|
|
PEEK at 26 WEEKS: “While there was more bone on the PEEK side at 26 weeks, there is still no bridging and erosion has increased.” “PEEK at 26 weeks, both histologically and on CT, looks like what we see clinically – an attempt to fuse but doesn’t quite get there.” |
 |
 |
|
|
ZFUZE at 26 WEEKS: “By contrast, the ZFUZE looks solid, including through the middle and right up to essentially all surfaces. The peek 26, both on histo and CT, looks like what we see clinically- an attempt to fuse, but doesn’t get there.” Commentary by Paul Kraemer M.D., study investigator and co-author. |
 |
 |
|
DiFusion’s Leadership Team
DiFusion started when Joe Crudden, Ph.D.., former senior R&D executive at AW Chesterton, WR Grace, Hampshire Chemical and Dow Chemical called Derrick Johns and asked in his thick Irish brogue “would you have use for this zeolite molecule in spine?”
Derrick asked, “Can we put it in polymers and ‘tune It’ for elution?” Dr. Crudden said, “It’s like an FM radio man, you can tune it to whatever station you want.”
And ZFUZE was born.
