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Cortiva™ and Cortiva™ 1mm Allograft Dermis

Implant Overview

About RTI Surgical• Strong commitment to advancing science, safety and innovation.

• Leading global surgical implant company providing safe biologic, metal and synthetic implants.

• Innovator in proprietary, validated tissue sterilization processes that include viral inactivation steps.

• More than five million implants sterilized with zero incidence of implant-associated infection.

• Accredited in the U.S. by the American Association of Tissue Banks, ISO 13485 Certified and an AdvaMed Member.

Table of ContentsIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Overall Implant Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Tutoplast® Tissue Sterilization Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Strength . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Revascularization and Remodeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Post-implantation Histology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Clinical Efficacy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

More Efficiency in the OR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Ordering Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1

Cortiva™ and Cortiva™ 1mm Allograft Dermis Non-crosslinked Acellular Dermal Matrix

Cortiva™ and Cortiva™ 1mm allograft dermis is a

non-crosslinked acellular dermal matrix. Processed through

the Tutoplast® Tissue Sterilization Process, the implant

offers a safe and natural biologic option for soft tissue repair.

The Cortiva implant offers three important components

of a biologic implant: safety, strength and support for

revascularization and remodeling . Additionally, processed

allograft dermis has been shown to be biocompatible with

a low inflammatory response3, making it suited for surgical

applications such as small incisional hernia repair and hiatal

hernia repair.

OVERALL IMPLANT FEATURES

• Multiple implant thicknesses provide consistent thickness for uniform repair: – Cortiva = 1.3mm (0.8 - 1.8mm) – Cortiva 1mm = 1.0mm (0.8 - 1.2mm)

SAFETY

Cortiva™ and Cortiva™ 1mm allograft dermis is processed through the Tutoplast® Tissue Sterilization Process.

• Validated multi-step chemical preservation and sterilization process that removes antigenicity and inactivates pathogens

• Validated low dose gamma irradiation achieves terminal sterility of SAL 10-6

SAFETY

2

TUTOPLAST® TISSUE STERILIZATION PROCESS (Cortiva allograft dermis)

The Tutoplast process was originally developed more than 40 years ago by Tutogen Medical®.

During the Tutoplast process, osmotic, oxidative and alkaline treatments break down cell walls, inactivate pathogens and remove bacteria. Solvent dehydration results in room temperature storage without damaging the native tissue structure. Overall the structure, biomechanics and remodeling characteristics of the implant are maintained. Low dose gamma irradiation ensures sterility of the final packaged graft.

TISSUE BEFORE PROCESSING

DONOR SCREENING & TESTING

(SEROLOGICAL & MICROBIOLOGICAL)

TUTOPLAST® TISSUE STERILIZATION

PROCESS

TISSUESHAPED INTO FINAL FORM

AND PACKAGED

LOW-DOSE TERMINAL

IRRADIATION

STERILE FINISHED GRAFT

TO SAL 10-6

INFECTIOUS DISEASE TESTING (FOR EVERY DONOR):

• HIV-1/HIV-2 Antibody

• Hepatitus C Virus Antibody

• Hepatitus B Surface Antigen

• Hepatitus B Core Antibody (Total)

• Syphilis

• Human T-Cell Lymphotropic Virus I/II Antibody

• HIV-1/HCV NAT-TMA

STRENGTH

Native allograft dermis is a naturally strong material comprised of a dense collagen network. If altered during processing, mechanical strength could be compromised. Cortiva allograft dermis has been shown to preserve this network of collagen fibers afer processing, thus maintaining strength and limiting stretch. This is important as it preserves mechanical strength characteristics that are well suited to resist the tensile forces placed on it during soft tissue repair.

In a head-to-head comparison against the market leading allograft, AlloDerm™, Cortiva allograft dermis demonstrated significantly greater load at failure and lower percentage elongation prior to reactive force.1

Cortiva allograft dermis has been shown to preserve the naturally strong material comprised of a network of dense collagen fibers after processing, thus maintaining strength and limiting stretch.

STRENGTH

3

Human dermis after the Tutoplast® Tissue Sterilization Process.

100mm

80

60

40

20

0

Elon

gatio

n (%

of l

engt

h)

Elongation prior to reactive force of Cortiva allograft dermis and AlloDerm tissue matrix.

Cortiva AlloDermCortiva AlloDerm

200

150

100

50

0

Load

at F

ailu

re (N

)

Loads at failure of Cortiva allograft dermis and AlloDerm tissue matrix.

REVASCULARIZATION & REMODELING

4

Implants were completely replaced by mature granulation tissue. The implant areas were partially compartmentalized by branching capillaries in an animal model.

REVASCULARIZATION AND REMODELING (ANIMAL MODEL)*

Cortiva allograft dermis demonstrated rapid revascularization and remodeling.2

Representative Masson's Trichrome histology photos of Cortiva allograft dermis at 16 weeks post-implantation demonstrate progressive tissue remodeling.

16 WEEKS POST-IMPLANTATION (40X) 16 WEEKS POST-IMPLANTATION (100X)

Representative Masson's Trichrome histology photos of Cortiva allograft dermis at seven days post-implantation show fibroblasts and capillaries have begun infiltration into the implant.

TD

M

TD

B

M

KEY

TD = Tutoplast Dermis

M = Muscle

B = Blood Vessels

= Polymorphoneutrophils

7 DAYS POST-IMPLANTATION (40X) 7 DAYS POST-IMPLANTATION (100X)

POST-IMPLANTATION HISTOLOGY

*Performance data from animal studies may not be representative of performance in humans.

MORE EFFICIENCY IN THE OR

• Rehydrates in 30 seconds compared to: – AlloDerm RTU two minute rinse – AlloDerm 10 - 20 minute rehydration – AlloMax™ five minute rehydration

• Flat mailer carton for space savings

CLINICAL EFFICACY

5

1 Data on file at RTI Surgical, Inc.

2 Greenspan D. C., Hernandez R., Faleris J. Histology of Surgically Implanted Tutoplast Processed Dermis. Unpublished data, 2008.

3 Faleris J. A., Hernandez R. M. C., Wetzel D., Dodds R., Greenspan D. C., In-vivo and in-vitro histological evaluation of two commercially viable acellular dermal matrices. Hernia. 2011. 15:147-156.

4 Roth J. S., Diaz D. F. Laparoscopic Paraesophageal Hernia Repair with Acellular Dermal Matrix Cruroplasty. JSLS, Journal of the Society of Laparoendoscopic Surgeons. (2011) 15:355-360.

5 Alicuben E.T., Worrell S.G., DeMeester S.R., Impact of Crural Relaxing Incisions, Collis Gastroplasty, and Non-Crosslinked Human Dermal Mesh Crural Reinforcement on Early Hiatal Hernia Recurrence Rates, Journal of the American College of Surgeons (2014), doi: 10.1016/j.jamcollsurg.2014.07.937.

CLINICAL EFFICACY4, 5

Laparoscopic paraesophageal hernia repair with Tutoplast sterilized allograft dermis.

PATIENT DEMOGRAPHICS AND RESULTS4

Age 60.3 ± 13.9 years

BMI 30.3 ± 5.3

Operative Time 182 ± 56 minutes

Length of Stay 2.6 days (range 1 to 8)

Recurrences • Clinical • Radiographic

2/46 (4.3%) 2/26 (7.7%)

Dysphagia 6/46 (13%)

Early Complications 9/46 (19.6%)

PATIENT DEMOGRAPHICS AND RESULTS5

Number of Patients 82

Age Average 63 years

Recurrence Rate 4% (3 patients)

Follow-up 1 year

See implant labeling for complete instructions for use.

Distributed by RTI Surgical, Inc.11621 Research Circle

Alachua, FL 32615 USAt: 877 .612 .4287

www.rtisurgical.com [email protected]

® indicates U .S . registration . All trademarks and/or images are the property of their respective owners or holders .

©2014 RTI Surgical, Inc. All rights reserved. 7405 R1 12/22/14

Call 877-612-4287 or email [email protected] to coordinate implant availability with your local representative.

CORTIVA ALLOGRAFT DERMIS IMPLANTS CORTIVA 1MM ALLOGRAFT DERMIS IMPLANTS

Part Number Description

DH0204 Cortiva Allograft Dermis 2 x 4cm
















Part Number Description

DH2412 Cortiva 1mm Allograft Dermis 4 x 12cm











ORDERING GUIDE

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cortiva and cortiva 1mm - home - lifehealthcare · soft tissue repair. in a head-to-head comparison...

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