The experience you need for a DBM you can trust.
RTI demineralized bone matrix is sterilized through the Cancelle SP® DBM Sterilization Process, which is designed to preserve protein activity. DBM osteoinductive (OI) potential is verified by 100% lot testing after irradiation. In their final form, the DBM grafts serve as bone void fillers in many applications, including spine, trauma, joint reconstruction, extremities and dental surgeries.
How does the Cancelle SP DBM Sterilization Process work?
The Cancelle SP Process is a proprietary process that sterilizes DBM while simultaneously allowing it to maintain its OI potential.* Through a combination of oxidative treatments and acid or alcohol washes, pathogens are removed or inactivated and debris is removed. Cleansing rinses remove residual chemicals and for most DBM-based grafts**, the low temperature, low-dose gamma irradiation is applied terminally to achieve a sterility assurance level (SAL) of 10-6. The process preserves the utility and biocompatibility of the graft.
100% LOT TESTING FOR OSTEOINDUCTIVITY
Each lot of DBM processed through the Cancelle SP Process is tested for OI potential after irradiation using one of two methods.
In Vivo Testing
The American Society for Testing Materials (ASTM) has proposed a DBM quality control test based on the intramuscular implantation of DBM into athymic rats with a standardized semi-quantitative histology scoring based on the system devised by Edwards.***