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REFERENCES

Data on file at Evergen.
AlloDerm Portfolio Page. Accessed 11/13/2025. https://hcp.alloderm.com/portfolio#contoursizeandthickness
FlexHD Pliable Product Specification Page. Accessed 11/13/2025. https://www.mtfbiologics.org/our-products/detail/flexhdpliable
Dermacell Product Specifications Page. Accessed 11/13/2025. https://www.lifenethealth.org/regenerative-wound-solutions/dermacell/dermacell
SimpliDerm Product Page. Accessed 11/13/2025. https://elutia.com/products/soft-tissue-repair/simpliderm/
Moyer, et. al. 2017. “A histological comparison of two human acellular dermal matrix products in prosthetic-based breast reconstruction.” Plastic and Reconstructive Surgery Global Open, December 2017, 5(12).
Keane AM, et al. “Cortiva vs AlloDerm in Prepectoral and Partial Submuscular Implant-Based Breast Reconstruction: A Randomized Clinical Trial.” Plast Reconstr Surg. 2023 Dec 12.
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. Guidance for Industry and Food and Drug Administration Staff. January 21, 2016. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research.
Gierek M, et al. “Human Acellular Dermal Matrix in Reconstructive Surgery-A Review.” Biomedicines. 2022 Nov 9;10(11):2870.
Lake, S. et. al., “Pore size and pore shape – but not mesh density – alter the mechanical strength of tissue ingrowth and host tissue response to synthetic mesh materials in a porcine model of ventral hernia repair.” Journal of the Mechanical Behavior of Biomedical Materials 42(2015) 186-197.
Kanchwala, S. Holton, T. Momeni, A. (2024, February 22). KOL discussion & feedback.
Keifer OP Jr, et al. “A Complication Analysis of 2 Acellular Dermal Matrices in Prosthetic-based Breast Reconstruction.” Plast Reconstr Surg GlobOpen. 2016 Jul 13;4(7):e800.
Deeken CR, Lake SP. “Mechanical properties of the abdominal wall and biomaterials utilized for hernia repair.” J Mech Behav Biomed Mater. 2017 Oct;74:411-427

* Performance data from animal models may not be representative of performance in humans.
^† Clinical cases are unique and individual results may vary.

‡ Lab data may not be representative of effects or performance in humans.

DESCRIPTION

Cortiva^® 1mm, Cortiva^® 1mm Tailored, Cortiva^® 1mm Perforated Tailored, and Cortiva Silhouette^® allograft dermis are dehydrated dermis from donated human tissue processed through the Tutoplast^® Tissue Sterilization process. The implants are preserved by the Tutoplast^® tissue sterilization process which retains the three-dimensional collagen structure responsible for the multidirectional, mechanical properties of the original dermal tissue. These implants are regulated as 361 human cell and tissue product (HCT/Ps) as defined in US FDA 21 CFR 1271 and are restricted to homologous use for the repair, replacement, reconstruction or augmentation of soft tissue by a qualified healthcare professional (e.g., physician). These implants are provided sterile and require rehydration prior to use.

WARNINGS

Cortiva Silhouette^®, Cortiva^® 1mm, Cortiva^® 1mm Perforated, Cortiva^® 1mm Perforated Tailored: The same potential 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, it is not possible to guarantee freedom from transmission of infectious agents or other adverse reactions such as hypersensitivity, allergic or immune response. Cortiva^® 1mm Tailored: 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. Cortiva Silhouette^®, Cortiva^® 1mm Perforated, Cortiva^® 1mm Perforated Tailored: Do not use the implant for abdominal wall repair, hernia repair or for other procedures that require substantial tensile strength. The implant should be used only where it is under minor to moderate tension. Cortiva Silhouette^®: Do not perforate the implant. Perforations may affect implant performance. Cortiva^® 1mm Perforated, Cortiva^® 1mm Perforated Tailored: Do not further perforate the implant. Additional perforations may affect implant performance.

PRECAUTIONS

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 the success of the surgical procedure.

All Cortiva^® and Cortiva Silhouette^®allograft dermis implants are processed by RTI Surgical, Inc. (Alachua, FL).

Please refer to the labeling for complete instructions for use.
Regulatory approvals vary by country. Therefore, we kindly ask you to contact the representative in your region regarding the availability of specific grafts in your country.
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