TranZgraft® exceeds expectations in safety for better performance in sports medicine surgery.

TranZgraft® is processed in an aseptic state-of the-art manufacturing environment with a proprietary gamma irradiation system that affords a Sterility Assurance Level (SAL) of 10-6 while preserving the native properties of the tissue.

THE GOLD STANDARD FOR STERILIZATION

Gamma irradiation is the trusted gold standard for sterilization.

  • Terminal sterilization performed at ultra-low temperatures and at low doses not exceeding 25 kGy, which better preserves the tissue structure
  • SAL of 10-6 translates to a 1,000-fold lower probability of contamination compared to an SAL of 10-3
  • Sterilization process validated by Method VDmax15 to ANSI/AAMI/ISO 11137 including periodic dose auditing
  • Inactivates a broad range of viruses, providing a greater degree of security1

OPTIMAL PROCESSING

Processing designed to protect tissue properties.

  • Only physiologic solutions like saline are used—not harsh chemicals (e.g. acetone, sodium hydroxide, or hydrogen peroxide) like some processors—for better preservation of the tissue structure
  • Stringent controls include strict bioburden limits and environmental monitoring
  • Carefully controlled gamma irradiation maintains biomechanical performance, including tensile strength and failure stiffness1-3

ALLOGRAFT SAFETY

  • Exceeds FDA, AATB, and State Regulatory requirements for testing and donor screening
  • In addition to standard transmissible disease testing including NAT, over 350 medical and social criteria are reviewed for every donor
  • Licensed medical director reviews and determines final medical release on all donor tissue

PRODUCT ORDERING INFORMATION:

TranZgraft includes a complete line of sports grafts, including of tendons and ligaments, in a wide range of sizes to meet the unique needs of your patients.  Please contact Aziyo for additional product details.

CUSTOMER SERVICE AND ORDERING:
orders@aziyo.com     800-922-3100

REFERENCES

  1. Moore MA. Cell Tissue Bank. 2012; 13:401-407.
  2. Greaves LL, American J Sports Med. 2008; 36:1358-1366.
  3. Samsell BJ, Moore MA. Cell Tissue Bank. 2012; 13:217–223.

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