Find out how Cortiva® allograft dermis delivers exceptional handling predictability that you can depend on.
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,‡
Predictability is our focus. Cortiva® allograft dermis grafts are precisely controlled to ± 0.1–0.125mm, measured every 2cm increment.1
Cortiva® allograft dermis grafts feature a precise thickness consistency range compared to other leading acellular dermal matrixes of similar thickness.1 Comparison based on publicly available specifications.
The proprietary sterilization process used for Cortiva® allograft dermis achieves a Sterility Assurance Level (SAL) of 10-6 while preserving the graft’s native dermal structure and biomechanical characteristics.1
1 in 1,000,000 chance a viable microorganism survives the sterilization process
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
Most used ADMs
1,000 times more likely to contain microorganisms than SAL 10-6
Some ADMs
Up to 1,000,000 times more likely to contain microorganisms than SAL 10-6
The proprietary processing used across the Cortiva® allograft dermis portfolio is validated to inactivate or remove a broad panel of viruses, bacteria, fungi, and spores, while preserving the native dermal structure and biomechanical characteristics.1,*
Processing removes cellular and DNA content (DAPI nuclear DNA stain. 20× magnification.)
H&E staining shows the preserved native structure in Cortiva® allograft dermis. Cells removed. Processing leaves native tissue intact (H&E Stain. 50× magnification.)
Our strict approach to dermal processing takes all the necessary steps to ensure the best outcomes. Our tissue sterilization process sterilizes tissue safely and effectively while maintaining native characteristics.
Osmotic treatment disrupts cell membranes to facilitate removal of cells and cellular debris.
Alkaline treatment removes cells and lipids.
Oxidative treatment removes immunogenic structures and viruses.
Solvent dehydration removes water and preserves the tissue.
Low-dose radiation produces a terminally sterile graft.
Cortiva® allograft dermis, processed using a proprietary method that maintains the native dermal structure, has demonstrated rapid revascularization and remodeling to support graft incorporation.1,6,7,9,*,†
In pre-clinical studies, cellular infiltration and capillary formation were observed as early as 7 days post implantation along with a favorable immune response consistent with normal wound healing.1,*
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 histology.
This graph illustrates the qualitative healing response to implanted Cortiva® allograft dermis in a pre-clinical study. Plotted as a concentration of various types of cells present in the explanted tissue as a function of time, the graph is consistent with the temporal sequence of normal wound healing.1,*
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 nearly twice as high with AlloDerm RTM than with Cortiva® 1mm allograft dermis (p=0.047) after adjustment for relevant covariates.7,†
Seroma
Hematoma
Infection
Necrosis
Dehiscence
Reconstructive failure
21 (7.6%)
4 (1.4%)
24 (8.7%)
17 (6.1%)
14 (5.1%)
23 (8.3%)
AlloDerm RTM
33 (12%)
10 (3.6%)
26 (9.3%)
22 (7.9%)
16 (5.7%)
26 (9.3%)
p-Value
0.09
0.17
0.80
0.43
0.73
0.68
The Cortiva® allograft dermis portfolio offers a variety of options. Surgeons can choose the thickness, size and shape of dermis to fit their surgical approach.
We deliver the highest standards of quality, proven safety, exceptional supply reliability and unwavering scientific integrity.
