Tutoplast® Pericardium Allograft
Coloplast offers Pericardium Allograft – preserved donated human tissue that has been sterilized through the Tutoplast®Tissue Sterilization Process.
2 x 7 cm
2 x 12 cm
4 x 7 cm
6 x 6 cm
Instructions For Use
Tutoplast® Pericardium Allograft Brief Statement
Tutoplast Processed Pericardium is dehydrated, Tutoplast processed pericardium from donated human tissue. The implant is preserved by the Tutoplast tissue sterilization process which retains the three-dimensional collagen structure responsible for the multidirectional, mechanical properties of the original pericardium tissue.
Tutoplast Processed Pericardium is regulated as a 361 human cell and tissue product (HCT/P) as defined in USFDA 21 CFR 1271 and is restricted to homologous use for the repair, replacement, reconstruction or augmentation of soft tissue by a qualified healthcare professional (e.g., physician). This includes grafting for horizontal and vertical soft tissue augmentation of thickness and length. The implant is provided sterile and requires rehydration prior to use.
The same medical/surgical conditions or complications that apply to any surgical procedure may occur during or following implantation. The surgeon is responsible for informing the patient of the risks associated with their treatment and the possibility of complications or adverse reactions. As with any human tissue implant, the potential for transmission of infectious agents may exist. A small number of patients may experience localized immunological reactions to the implant. Successful treatment is dependent upon the patient’s host tissue response. Resorption of the implant and commensurate substitution with functional host tissue is required to restore function.
Prior to use, the surgeon must become familiar with the implant and the surgical procedure. Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients for procedures using this implant; as such conditions may compromise outcomes.
The implant should be used with caution in surgical sites where an active infection is present or in sites with poor perfusion. If the surgeon determines that the clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken. Appropriate placement and fixation of the implant are critical to success of the surgical procedure.
Tutoplast is a registered trademark of Tutogen Medical GmBH.