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Product Overview

Applications where PRO-DENSE® graft has been used:

  1. Metaphyseal Fractures, such as:
    • Tibial plateau
    • Proximal humerus
    • Distal Radius
    • Calcaneus
  2. Benign Bone Cysts, such as:
    • Aneurysmal
    • Unicameral
    • Enchondroma
  3. Core Decompression procedures
  4. Osteotomies
Indications:
PRO-DENSE® resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis) to cure in situ. These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that can be resorbed and replaced with bone during the healing process.

The PRO-DENSE® paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

PRO-DENSE® paste is provided sterile for single use only.

PRO-DENSE® Injectable Regenerative Graft is a revolution in synthetic biomaterial development. Combining the bone forming capabilities of calcium sulfate with calcium phosphate has resulted in a truly unique composite graft that is delivering where other materials may fall short.

Immediate intra-operative strength
Approximately 40MPa initial compressive strength
(at 2 hours, wet conditions)*
Reliable/consistent resorption

50% slower than pure calcium sulfate
Composite makeup:*

75% CaSO4
 

  • Primary osteoconductive filler
  • Resorbs first primarily through simple dissolution to allow early vascular infiltration
  • Excellent clinical history

25% CaPO4
(brushite and granular TCP)

  • Osteoclastic resorption
  • Secondary porous scaffold that is resorbed after primary filler
  • TCP granules are resorbed in the third and final phase

6-week PRO-DENSE® Graft Specimen

New blood vessels (arrows); note prominent osteoblastic rimming intimately associated with residual calcium sulfate and calcium phosphate (black) and TCP (grey).

(Canine proximal humerus, 9x15mm defect, basic fuchsine and toluidine blue, original mag 300x)

"The PRO-DENSE® material may very well represent the next new class of biomaterials for bone regeneration in contained metaphyseal defects."
Thomas M. Turner, DVM
Rush University Medical Center

* Data on file

 

 
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