Cortiva and Cortiva 1mm - Home - LifeHealthcare

CortivaTM and CortivaTM 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 Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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

CortivaTM and CortivaTM 1mm Allograft Dermis

Non-crosslinked Acellular Dermal Matrix

CortivaTM and CortivaTM 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)

1

SAFETY

SAFETY CortivaTM and CortivaTM 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

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.

DONOR SCREENING & TESTING

(SEROLOGICAL & MICROBIOLOGICAL)

TISSUE BEFORE PROCESSING

TUTOPLAST? TISSUE STERILIZATION

PROCESS

TISSUE SHAPED 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

2

STRENGTH

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.

100mm

Human dermis after the Tutoplast? Tissue Sterilization Process.

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.

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

Load at Failure (N) Elongation (% of length)

Cortiva 200

AlloDerm

150

100

50

0

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

Cortiva AlloDerm 80

60

40

20

0

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

3

REVASCULARIZATION & REMODELING

REVASCULARIZATION AND REMODELING (ANIMAL MODEL)* Cortiva allograft dermis demonstrated rapid revascularization and remodeling.2

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

TD

M

7 DAYS POST-IMPLANTATION (100X)

TD B M

KEY TD = Tutoplast Dermis M = Muscle B = Blood Vessels

= Polymorphoneutrophils

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.

16 WEEKS POST-IMPLANTATION (40X)

16 WEEKS POST-IMPLANTATION (100X)

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

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

4

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

CLINICAL EFFICACY

CLINICAL EFFICACY4,5 Laparoscopic paraesophageal hernia repair with Tutoplast sterilized allograft dermis.

PATIENT DEMOGRAPHICS AND RESULTS4

Age BMI Operative Time Length of Stay

Recurrences ? Clinical ? Radiographic

Dysphagia Early Complications

60.3 ? 13.9 years 30.3 ? 5.3 182 ? 56 minutes 2.6 days (range 1 to 8)

2/46 (4.3%) 2/26 (7.7%) 6/46 (13%) 9/46 (19.6%)

PATIENT DEMOGRAPHICS AND RESULTS5

Number of Patients Age Recurrence Rate Follow-up

82 Average 63 years 4% (3 patients) 1 year

MORE EFFICIENCY IN THE OR

? Rehydrates in 30 seconds compared to: ? AlloDerm RTU two minute rinse ? AlloDerm 10 - 20 minute rehydration ? AlloMaxTM five minute rehydration

? Flat mailer carton for space savings

See implant labeling for complete instructions for use.

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,

5

Journal of the American College of Surgeons (2014), doi: 10.1016/j.jamcollsurg.2014.07.937.

ORDERING GUIDE

CORTIVA ALLOGRAFT DERMIS IMPLANTS

Part Number DH0204 DH0412 DH0416 DH0420 DH0508 DH0510 DH0612 DH0616 DH0620 DH0710 DH0816 DH1010 DH1015 DH1220 DH1315 DH1620

Description Cortiva Allograft Dermis 2 x 4cm Cortiva Allograft Dermis 4 x 12cm Cortiva Allograft Dermis 4 x 16cm Cortiva Allograft Dermis 4 x 20cm Cortiva Allograft Dermis 5 x 8cm Cortiva Allograft Dermis 5 x 10cm Cortiva Allograft Dermis 6 x 12cm Cortiva Allograft Dermis 6 x 16cm Cortiva Allograft Dermis 6 x 20cm Cortiva Allograft Dermis 7 x 10cm Cortiva Allograft Dermis 8 x 16cm Cortiva Allograft Dermis 10 x 10cm Cortiva Allograft Dermis 10 x 15cm Cortiva Allograft Dermis 12 x 20cm Cortiva Allograft Dermis 13 x 15cm Cortiva Allograft Dermis 16 x 20cm

CORTIVA 1MM ALLOGRAFT DERMIS IMPLANTS

Part Number DH2412 DH2416 DH2508 DH2612 DH2616 DH2710 DH2812 DH2816 DH2820 DH3015 DH3620

Description Cortiva 1mm Allograft Dermis 4 x 12cm Cortiva 1mm Allograft Dermis 4 x 16cm Cortiva 1mm Allograft Dermis 5 x 8cm Cortiva 1mm Allograft Dermis 6 x 12cm Cortiva 1mm Allograft Dermis 6 x 16cm Cortiva 1mm Allograft Dermis 7 x 10cm Cortiva 1mm Allograft Dermis 8 x 12cm Cortiva 1mm Allograft Dermis 8 x 16cm Cortiva 1mm Allograft Dermis 8 x 20cm Cortiva 1mm Allograft Dermis 10 x 15cm Cortiva 1mm Allograft Dermis 16 x 20cm

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7405 R1 12/22/14

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