Advantages of the Gammalink® Process in Bone Growth Stimulants
The following unique advantages are obtained by the patented radiation crosslinked demineralised bone matrix (DBM*) in collagen, and used in commercial clinical practice in South Africa since July 2004:
- The crosslinked DBM* shows a marked enhancement in osteogenic potential, providing a safe and easy-to-use demineralised allograft and xenograft as compared to non-crosslinked demineralised bone.
- The new bone growth resulting from the use of crosslinked DBM* shows an almost 300% increase in strength compared to that of non-crosslinked demineralised bone.
- A further advantage of the crosslinking of the DBM substrate is its increased mechanical strength and its relative insolubility, ensuring it does not wash away upon implantation, factors which have previously limited the use of DBM in surgical settings.
- The formation of the putty or gel reconstituted from the dry crosslinked DBM* takes place much faster than the non-crosslinked equivalent – a property that is advantageous during implantation. The faster solidifying gels are also better retained at the implantation site, an important factor therapeutically under conditions of bleeding. This allows for the benefits of the full dose of DBM to be delivered to the surgical site.
- The crosslinked dry DBM* is stored under inert nitrogen gas, eliminating oxidative degradation. This obviates the need to transport and store the product under refrigerated conditions, resulting in a shelf-life of at least five years. The product is reconstituted in fresh form in theatre directly before use.
- The novel delivery system has been developed specifically for this product and is superior to similar delivery systems presently available. The premixed lyophilised components are integrated in a single pack for ease of use and sterility is maintained throughout with no increased risk of contamination during reconstitution of the product.
- The proprietary processing system allows for the osteoinductive mixture and water for re-hydration to be subjected to a terminal gamma radiation sterilisation process with the associated very high degree of sterility assurance and safety guaranteed to the patient
- Clinical experience in South Africa has indicated that the product in its final packaged form is easy to use, and is both safe and clinically effective.