Product Overview

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

Applications where PRO-DENSE® graft has been used:

  1. Osseous Defects
  2. Core Decompression procedures

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 and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

The PRO-DENSE® paste cured in situprovides 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® is provided sterile for single use only.

Contraindications

The PRO-DENSE® Bone Graft Substitute injectable paste is contraindicated where the device is intended as structural support in load-bearing bone and in articulating surfaces. Conditions representing relative contraindications include:

  • Severe vascular or neurological disease
  • Uncontrolled diabetes
  • Severe degenerative bone disease
  • Closed bone void/gap filler
  • Pregnancy
  • Uncooperative patients who will not or cannot follow postoperative instructions, including individuals who abuse drugs and/or alcohol
  • Hypercalcemia
  • Renal compromised patients
  • Patients with a history of or active Pott’s disease

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

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

product_overview_1 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)


Data on file*

STRONGER THAN NORMAL BONE*: At 13 weeks; Urban, et al… CORR, June 2007.
* 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.