Tutoplast Whole Sclera
The patented Tutoplast® processed tissue technology has been partnered with whole human sclera to produce an optimal wrap for orbital implants.
The uniform and consistent tissue quality enables the host tissue to firmly incorporate into the BioDome where it has been replaced by cell-rich , well vascularized endogenous connective tissue.
Since technology Tutoplast® Pericardium and Sclera allografts have been employed by ophthalmic surgeons throughout the world to treat a variety of ocular conditions.
The surgical use of the Tutoplast® allografts as a tectonic support, epithelialization substrate or superficial patch graft has been well documented. The Tutoplast® Process is scientific and technology based method of virally inactivating, preserving and sterilizing human tissue. The Tutoplast® benefits are vast:
- Immunologically safe.
- Biologically and mechanically stable.
- Five year shelf life/Room temperature storage.
- Uniform and consistent in tissue quality.
- Improved suturability and handling.
During the last 30 years, over 1 million Tutoplast® Allografts have been surgically implanted without a single documented case of disease transmission.
Tutoplast® is a registered trademark of Tutogen Medical, USA.
Tutoplast® Processed Pericardium is a solvent dehydrated, gamma-irradiated preserved human pericardium. Recovery: All tissue recovered meets stringent specifications during donor screening and laboratory testing to reduce the risk of transmitting infectious disease.
- Tutoplast® Processed Pericardium remains sterile and non-pyrogenic as long as the package is not opened and/or damaged. The graft must be used before the expiration date.
- Appropriate placement and fixation are critical factors in the avoidance of potentially adverse effects on graft service life.
- The adsorption process and reformation of endogenous tissue begins one to two days after implantation and continues for weeks, months, or years, depending on the size of the graft and the responsiveness of the graft site.
The processing of all Tutoplast® tissue consists of a strict, quality-controlled procedure, which involves thorough cleaning, processing, dehydration, and preservation.
The process leaves no deleterious residue and minimizes antigenic potential. Additional assurance of sterility is achieved with the use of a target of 25 kGy (2.5 Mrads) of gamma radiation. Based on previous trials with gamma irradiation, the level used in the Tutoplast® process effectively significant adverse effect on the biomechanical properties of the tissue.
Tutoplast® Processed Pericardium is indicated for implantation with a specific spectrum of indications. Collagenous connective tissue with multidirectional fibers retains the mechanical strength and elasticity of native pericardium, while providing the basic formative structure to support replacement by new endogenous tissue. This tissue is indicated for use in a variety of surgical applications, including duraplasty (as a substitute for human dura mater), and in abdominal, urological, ophthalmological, and vascular surgery.
- Implantation into areas with active or latent infection or signs of tissue necrosis.
- Implantation into areas with a compromised circulation.
- Any disorder which would create an unacceptable risk of post-operative complications.
- As with any surgical procedure, the possibility of infection exists.
- Although the Tutoplast® process is designed to eliminate antigenic properties of the graft, the possibility of rejection is present in any allograft procedure.
- Reoperation could be necessary to correct adverse effects.
- Adverse reactions should be immediately reported to Tutogen Medical, U.S., Inc.
- This graft has been sterilized by a target of 25 kGy (2.5 Mrads) of gamma radiation to provide sterility throughout the unit.
- The Packaging of all sterile products should be inspected for flaws in the sterile barrier before opening. In the presence of such a flaw, the product must be assumed nonsterile.
- Care should be taken to prevent contamination of the graft. In the event of such contamination, this product must be discarded.
- If the package has been opened, but the product is not used, the graft must not be resterilized and must therefore be discarded.
- It is recommended that Tutoplast® Processed Pericardium be rehydrated prior to use by soaking in 0.9% saline solution for 5 to 30 minutes, depending on the consistency desired, using aseptic/sterile technique.
- Tutoplast® Processed Pericardium is packaged in various sizes (length and width). The size of the section used should correspond to the size of the respective defect.
- The surgeon should monitor the effect of rehydration by visual inspection after completing the rehydration and while cutting and shaping the allograft.
- Implantation should be preformed in such a way that the free edges of the implant do not extend into areas where the possibility of adhesion may present a problem.
- Absorbable or nonabsorbable suture material can be used to fix Tutoplast® Processed Pericardium.
- For a Continuous suture, absorbable suture material and round atraumatic needle are recommended.
- Suture gauge depends on the surgical indication.
- The suture should be located two to millimeters from the edge of the graft.
- Better results are obtained by doubling the section at suture sites that are under moderate to high stress.
This product should be stored in a clean, dry place at controlled room temperature of 15*C to 30* C (59* to 86* F).
- Tutoplast® Processed tissues have been used for over 25 years in more than 750,000 surgical transplant cases with an outstanding safety record. As with all biological products, it is not possible to give an absolute guarantee of freedom of transmitting infectious diseases such as hepatitis and CJD. Processed treatments shown to be capable of reducing the risk of any transmission as well as strict donor screening and laboratory testing are used to decrease the risk.
- The reaction of the body to any allograft is not completely understood.
- Discard all damaged or mishandled grafts or when possible contamination of the graft has occurred.
- Return all packages with flaws in the sterile barrier to the supplier.
- Unused tissue should be properly discarded.
- DO NOT RE-STERILIZE.
- Single patient use only.
The relevance of the reimbursement codes depends on indications of use and geographic region.
Please use the hotline or email to determine what the guidelines are for your area.
IOP Reimbursement Hotline: 1.888.700.9005
IOP Reimbursement Email: firstname.lastname@example.org