Ptosis Slings (Brow Suspension Surgery)

The Tutoplast™ Benefits......

Immunologically safe

Problem:

HIV/CJD/Pathogens - A recent clinical report identified polymerase chain reaction evidence of the HIV genome in sclera sourced from HIV-1 seropositive donors.¹ Although rare, transmission of HIV-1 by seronegative organ and tissue donors has been documented.²

Solution:

The patented Tutoplast process meticulously eliminates or inactivates pathogens of major concern to you and your patients.³

Mechanically strong

Our process not only assures you and your patients the safest tissue possible, but also delivers a better bioimplant with a viable, intact and strong collagenous matrix.

“There was no inflammation, foreign body reaction or allergic reaction during the recovery period of any of these patients, and no tendency was shown for the strength of the fascia lata to deteriorate.....” ⁴

“The results of this study suggest that a commercially available solvent-dehydrated form of fascia lata provides a more suitable grafting material than freeze-dried specimens.....” ⁵

Simple

• Single use, sterile packaging
• Activates in simple saline within minutes
• Five (5) year shelf life
• Reduced O.R. time/No autografts or secondary surgical sites required

During the past 30 years, over 1 million Tutoplast® Bioimplants have been surgically implanted without a single documented case of disease transmission.

Screening

U.S. FDA serological testing protocols are followed. No donor pooling is allowed. Tissue is rejected if the donor has a medical or social history that indicates risk of infectious disease or malignancy.

Tissue Processing– Phase 1

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

Osmotic Treatment

• Cells and bacteria are removed.
  
• Potential viruses are isolated for subsequent Phase 2 inactivation.
  
• Amajority of antigens are destroyed.
  

Tissue Processing – Phase 2

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

NaOH Treatment

• Prions inactivation
  
• Virus destruction
  
• Collagenous preservation

H2O2 Treatment

• Antigen removal
  
• Collagenous preservation
  

Preservation

Non-caustic, organic solvents with disinfectant properties are
employed to gently extract the water from the tissue. No chemical
residue remains and the inherent collagenous matrix is preserved.

Final Packaging

The tissue is cut to specified sizes and packaged in transparent,
double-peel pouches. The grafts are then terminally sterilized
by 2.5 mRads of gamma-irradiation.

The Tutoplast Process is a fully integrated science and technology-based method of virally inactivating and preserving human tissue for surgical implantation.

1. Seiff SR, Chang JSJ, Hurt MH, Khayam-Bashi H. Polymerase chain reaction identification of human immunodeficiency virus-1 in preserved human sclera. Am J Ophthalmol 1994: 118: 528-30.
2. Simonds R.J., et al. Transmission of human immunodeficiency virus type 1 from a seronegative organ and tissue donor. The New England Journal of Medicine. 1992. Vol. 326, No.11.
3. Brown P, et al. Sodium hydroxide decontamination of Creutzfeld-Jakob Disease virus. The New England Journal of Medicine. Vol. 310, No.11.
4. Abe S., et al. “Clinical experiences with solvent dehydrated fascia lata in plastic surgery”. Jap Journal Plast Reconst Surg. 1991. Vol 11, 721-730.
5. Hinton R, Jinnah RH, Johnson C, et al. A biomechanical analysis of solvent-dehydrated and freezedried human fascia lata allografts. Am J Sports Med 1992;20: 607-612.

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