Description of the Wright Medical Wright Medical Pro-Dense Injectable
Predictable Bone Regeneration
Stronger New Bone*
Faster, Denser Bone Regeneration*
Remodel to Normal Bone*
*All claims based on a critically sized canine proximal humerus defect model. It is unknown how results from the canine model compare with clinical results in humans. Data on file at Wright.
PRO-DENSE™ Graft is a synthetic biomaterial. Combining calcium sulfate with calcium phosphate, has result?ed in a composite graft that is delivering where other materials may fall short.
PRO-DENSE™ Graft has a triphasic resorption profile that provides an ideal environment? for the direct deposition of bone resulting in a slow-resorbing matrix that supports healing across the defect.?†
†Growth factor binding based on in vitro data of BMP-2 and VEGF. Data on file.?
Faster than Autograft*
The accelerated rate of healing of the PRO-DENSE™ graft treated defects compared to those treated with autograft is principally evident by the higher density bone (i.e., 170% average increase in area fraction of new bone compared to autograft at 13 weeks) and superior average mechanical properties at 13 weeks.
Denser than Autograft*
Histomorphometry reveals that the amount of newly regenerated bone of the PRO-DENSE™ injectable graft treated defects at 13 weeks demonstrated a statistically significant 170% average increase in new bone formation versus defects treated with autograft. PRO-DENSE™ injectable graft new bone area fraction is on average 170% denser than autograft at 13 weeks.
Stronger than Autograft*
The newly regenerated bone in the PRO-DENSE™ injectable graft treated defects exhibited a 645% average increase in compressive strength at 13 weeks versus defects treated with autograft.
Approximately 40MPa initial compressive strength (at 2 hours, wet conditions)* Reliable/consistent resorption 50% slower than pure calcium sulfate
*All claims are based on a critically sized canine proximal humerus defect model. It is unknown how results from the canine model compare with clinical results in humans.
Primary osteoconductive filler
Resorbs first primarily through simple dissolution to allow early vascular infiltration
25% CaPO4 (brushite and granular TCP)
Secondary porous scaffold that is resorbed after primary filler
TCP granules are resorbed in the third and final phase
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