Our Advantage
5 reasons surgeons choose Cortiva® allograft dermis
Exceptional handling predictability
Proprietary
gentle
processing
Rapid
graft
incorporation
Comprehensive
portfolio
Proven
commitment
to quality

Exceptional handling predictability

Dermis thickness impacts handling characteristics such as pliability and conformability. The Cortiva® allograft dermis portfolio features a uniform thickness throughout the graft and tight thickness specification tolerances to provide a consistent and predictable handling experience for surgeons.1

Conformable and pliable, with a consistent
handling experience.1

Proven commitment to quality

Precise thickness consistency of +/- 0.1 - 0.125mm.1
Measurements are taken every 2cm to ensure thickness consistency across the entire graft.1
Graft length and width are confirmed twice using a laser-calibrated ruler.1
All grafts conform to specifications without deviation. Graft measurements are not averaged.

Proprietary gentle processing

Cortiva® allograft dermis' proprietary processing achieves a Sterility Assurance Level (SAL) of 10-6 while preserving the graft's native dermal structure and biomechanical characteristics.1

Sterility assurance level of 10-6

U.S. Food and Drug Administration (FDA) recommendation for medical devices: The sponsor should state the Sterility Assurance Level (SAL) of 10-6 for devices labeled as sterile. FDA recommends a SAL of 10-3 for devices intended only for contact with intact skin.8
1 in 1,000,000 chance a viable microorganism survives the sterilization process
1,000 times more likely to contain microorganisms than
SAL 10-6
Up to 1,000,000 times more likely a viable microorganism survives the sterilization process

Native dermal structure

Cortiva® allograft dermis’ proprietary processing is validated to inactivate or remove a panel of harmful viruses, bacteria, fungi and spores – while preserving the native structure and biomechanical properties of dermis.1,*
Unprocessed human dermis1
DAPI nuclear stain (20x)
Processing removes cellular and DNA content (DAPI nuclear DNA stain. 20x magnification.)
Proprietary processing
Cortiva® allograft dermis1
DAPI nuclear stain (20x)
Cells removed
‍
Proprietary
processing
Unprocessed human dermis1
(H&E 50x)
Processing leaves native tissue intact
(H&E Stain. 50x magnification.)
Proprietary processing
Cortiva® allograft dermis1
(H&E 50x)
H&E staining shows the preserved native structure in Cortiva® allograft dermis. Cells removed
‍

Processing makes the difference

1. Alkaline treatment
Removes cells and lipids which interfere with healing.
2. Osmotic treatment
Disrupts cell membranes to allow easier removal of cellular components.
3. Oxidative treatment
Removes immunogenicity structures, enveloped and non-enveloped viruses.
4. Solvent treatment
Removes water from tissue, preserves the natural tissue matrix.
5. Irradiation
Irradiation produces a terminally sterile graft, while preserving structural integrity.
Images depict dermal processing.

The Cortiva® allograft dermis difference

Packaged
preservative free1
Normal immune
response1,6,9,†
Up to 5-year
shelf life1
At least 30 seconds
rehydration time1
Please refer to the labeling for complete instructions for use.

Rapid graft incorporation

Cortiva® allograft dermis, processed using a proprietary method that maintains the native dermal structure, has demonstrated rapid revascularization and remodeling to support graft incorporation into the host.6,7,9,†,*

Pre-clinical results1,*
(100x)

In pre-clinical studies of cellular infiltration and histology, capillary formation was observed as early as 7 days post implantation along with a favorable immune response consistent with normal wound healing.1,*

Clinical results6,†
(100x)

In a clinical setting, 13 patients underwent a second planned procedure where the graft
was biopsied, and robust revascularization and incorporation were observed.6,†
Images: Representative Masson’s Trichrome

Level 1 clinical evidence

In a prospective randomized controlled trial of 302 patients, outcomes with Cortiva® 1mm allograft dermis (151 patients) were compared to outcomes with AlloDerm RTM (151 patients). The study noted that the odds of seroma formation were almost 2-fold higher with AlloDerm RTM than with Cortiva® 1mm allograft dermis (p=0.047) after adjustment for relevant covariates.7,†
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Comprehensive portfolio

Surgeons can choose the right shape, size, and thickness of dermis to fit their surgical approach.

The thinnest cut for exceptional pliability

Cut exclusively from the middle of the dermis, and with the thinnest dimensions available, Cortiva Silhouette® allograft dermis is one of the most pliable ADMs on the market.1

Consistent thickness for predictable graft handling

With precise thickness consistency and multiple sizes to choose from, Cortiva® 1mm allograft dermis provides you a predictable option for excellent handling.1,6,7,12,†

Unique hexagonal perforation

A novel configuration featuring a distinctive pattern of hexagonal perforations. Hexagonal perforations were shown to give greater multi-directional expansion compared to other perforation shapes.10,*

For patient centric customization

Designed for a better fit, Cortiva® 1mm Tailored allograft dermis supports greater surgical precision and patient centric customization.11

Proven commitment to quality

We deliver:

Highest standards of quality

  • Precise tolerances for allograft thickness and size.1
  • To ensure each measurement meets our strict specifications, graft measurements are not averaged and processes include relevant controls to ensure graft consistency.1
  • Tissue processors and donor chart reviewers have an average of 10+ years of experience and are supported by two medical directors who are licensed physicians.1

Proven safety

  • More than 8.8 million tissue-based implants have been processed through Evergen’s proprietary, validated sterilization processes with zero confirmed incidences of implant-associated infection.1
  • We maintain the highest level of sterility (SAL 10-6) for Cortiva®  allograft dermis, without impacting the natural structure of the dermis.1,*
  • Clinical studies demonstrate an excellent safety profile.6,7,12,†

Exceptional supply reliability

  • Significant investments in processing capacity and operational excellence support a +>99% on-time delivery rate for Cortiva®  allograft dermis.1
  • Long-standing partnerships with leading tissue procurement organizations and tissue bank certifications seamlessly integrate our supply chain with implant processing.1
  • Investments in state-of-the-art technology enable us to maximize the gift of tissue donation.

Unwavering scientific integrity

  • 80,000 square feet of laboratory and processing space dedicated to researching new applications of human tissue, and improving and validating new tissue processing methods.1
  • Proudly hosts numerous healthcare practitioner education programs, including peer-to-peer round tables to foster discussions among surgeons nationwide, regardless of their product preferences or preferred techniques.
  • Evergen Donor Services supports tissue procurement partners through in-depth technical training to optimize recovery outcomes and maximize the gift of tissue donation.1

Coordinate implant ordering with your local representative:

800-624-7238

customerservice@evergenbio.com
References
  1. Data on file at Evergen.
  2. AlloDerm Portfolio Page. Accessed 02/28/2024 https://hcp.alloderm.com/portfolio#PerforatedContour
  3. FlexHD Pliable Product Specification Page. Accessed 02/28/2024 https://www.mtfbiologics.org/our-products/detail/flexhdpliable
  4. DermACELL Product Specifications. Accessed 02/28/2024 https://www.lifenethealth.org/wound-management-surgical-reconstruction/dermacell/dermacell-product-specifications
  5. SimpliDerm Product Page. Accessed 02/28/2024 https://elutia.com/products/soft-tissue-repair/simpliderm/
  6. 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).
  7. 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.
  8. 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.
  9. Gierek M, et al. "Human Acellular Dermal Matrix in Reconstructive Surgery-A Review." Biomedicines. 2022 Nov 9;10(11):2870.
  10. 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.
  11. Kanchwala, S. Holton, T. Momeni, A. (2024, February 22). KOL discussion & feedback.
  12. 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.
* Performance data from animal models may not be representative of performance in humans.
† Clinical cases are unique and individual results may vary.
DESCRIPTION
Cortiva® 1mm, Cortiva® 1mm Tailored, Cortiva® 1mm Perforated, 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 PERFORATED, CORTIVA 1MM: 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, 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: 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 1MM PERFORATED: 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. Do not further perforate the implant. Additional perforations may affect implant performance. 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.
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 distributor in your region regarding availability of specific products in your region.

® indicates U.S. trademark registration. All trademarks and/or images are the property of their respective owners or holders.
© Evergen 2025 / RTI Surgical, Cook BioTech and Collagen Solutions are now Evergen. All rights reserved.
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