Peyronie’s disease is a condition marked by penile curvature (with or without pain) upon erection.  These deformities of the penis can appear in men of all ages, but is most commonly present in men in their 50’s. Erectile dysfunction is also found to occur in up to 90% of men with Peyronie’s disease.

Tutoplast Processed Pericardium

The Tutoplast process inactivates and sterilizes human tissue, rendering it contamination free and preserving it for surgical implantation.  This is done through cleaning, processing, dehydration and preservation.  Organic material is removed, tissue integrity is preserved and antigenic potential is minimized.

Screening

U.S. FDA serological testing protocols are followed.  All tissue must pass stringent cleanliness, quality, structure and size standards.  No donor pooling is allowed.  Material is rejected if the tissue donor has a medical or social history that indicates risk of infectious disease or malignancy.

Tissue Processing – Part 1

Tissues are cleaned with a saline solution made of various concentrations.  This results in the osmotic destruction of cells, reducing tissues to their fiber and mineral components.

Osmotic Treatment:

• Cells and bacteria are destroyed and removed
• Viruses are exposed so they can be inactivated or destroyed
• Most of the antigenicity is removed

Tissue Processing – Part 2

Inorganic agents are used in specific concentrations to inactivate HIV, hepatitis and Cruetzfeldt-Jakob Disease (CJD).  This denaturization is achieved without significant alterations to the collagenous structure.

NaOH Treatment:

• Prions are inactivated
• Viruses are completely destroyed
• Time exposed to NaOH is limited to avoid significant weakening of the collagen.

H2O2 Treatment:

• Antigens are entirely removed
• Collagens are not damaged

Preservation

Organic solvents with disinfectant properties are used to extract water from the tissue.  The dense collagenous fiber structure is preserved and no chemical residue remains.

Final Packing

Tissue is cut into standardized sizes and packaged in transparent, double-peel pouches.  Each bioimplant is then terminally sterilized by gamma-irradiation.