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Recombinant Human Platelet Derived Growth Factor-BB

DEVICE DESCRIPTION:

GEM 21S ® is a completely synthetic grafting system for bone and periodontal regeneration composed of a purified recombinant growth factor and a synthetic calcium phosphate matrix.

GEM 21S ® is composed of two sterile components:

β3-TCP [Ca3 (PO4)] synthetic beta-tricalcium phosphate; and rhPDGFBB recombinant human platelet-derived growth factor-BB.

Synthetic beta-tricalcium phosphate (β3-TCP) [Ca3 (PO4)] is a highly porous, resorbable osteoconductive scaffold or matrix that provides a framework for bone ingrowth, aids in preventing the collapse of the soft tissues and promotes stabilization of the blood clot. Pore diameters of the scaffold are specifically designed for bone ingrowth and range from 1 to 500 um. The particle size ranges from 0.25 to 1.0 mm and highly purified, recombinant human platelet-derived growth factor-BB (rhPDGF-BB). PDGF is a native protein constituent of blood platelets. It is a tissue growth factor that is released at sites of injury during blood clotting. Extensive in vitro and animal studies have demonstrated its potent mitogenic (proliferative) and chemotactic (directed cell migration) effects on bone and periodontal ligament derived cells. Animal studies have shown PDGF to promote the regeneration of periodontal tissues including bone, cementum, and periodontal ligament (PDL). The contents of the cup of β3-TCP is supplied sterile by gamma irradiation. Sterile rhPDGFBB is aseptically processed and filled into the syringe in which it is supplied.

INDICATIONS:

GEM 21S ® is indicated to treat the following periodontally related defects:

  • Intrabony periodontal defects;
  • Furcation periodontal defects;
  • Gingival recession associated with periodontal defects.
  • Extraction sockets 
  • Jaw bone atrophy

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