Pericardium

Pericardium consists of human collagen. All of the tissues supplied by Coloplast and manufactured by RTI Biologics are selected in compliance with stringent specifications governing donor selection and serological testing in order to minimize the risk of transmitting infectious diseases.

There has been zero incidence of allograft-associated infection in more than 1.5 million implants sterilized through the Tutoplast process. (cf. 3)

Characteristics

Multi-directional fibers allow for the thin, conformable membrane to adapt to any shape; tissue thickness ranges between 0.3 mm - 0.5 mm

Tutoplast® Process

Pericardium Allograft tissue is sterilized through the Tutoplast Tissue Sterilization Process. This proprietary process thoroughly penetrates tissue, inactivates pathogens, removes bacteria, viruses, fungi and spores, all while preserving the  biomechanical/biochemical integrity and collagen structure of the tissue. (cf. 4)
 
The Tutoplast process is a chemical sterilization methodology developed more than 30 years ago to sterilize and preserve tissue for implantation.
During the Tutoplast process, osmotic, oxidative and alkaline treatments break down cell walls and inactivate or remove pathogens. Solvent dehydration results in tissue that is able to be stored at room temperature without damaging the collagen structure. Low dose gamma irradiation ensures sterility of the final packaged product. (cf. 3).
This tissue is not cross linked, nor is it freeze dried.

Tutoplast is validated to inactivate the following viruses:

Sinbis/Bovine Viral Diarrhea Virus (BVDV) Model

• Human Immunodeficiency Virus (HIV)
• Hepatitis C Virus (HCV)
• Human T-lymphotropic Virus (HTLV)

Pseudorabies Virus (PrV) Model

• Hepatitis B Virus (HBV)
• Herpes Virus Model (PrV)
• CMV

Human Poliovirus (Polio-1) Challenge

• Hepatitis A Virus (HAV)

Porcine Parvovirus (PPV) Challenge

• Parvovirus B19

Validated low dose gamma irradiation achieves terminal sterility of SAL 10-6.

References:

1. FAQs – RTIhttp://www.rtix.com/en_us/patients/faqs
2. Histology of Surgically Implanted Tutoplast®-Processed Dermis, 4883, David Greenspan
3. Tutoplast Tissue Sterilization Process, 5686 R1, RTI.
4. Patient Safety through Redundant Safeguards, 4455 R1, RTI.