OUTCOMES. Value analysis committee

MINIMIZECOMPLICATIONS.

MAXIMIZEOUTCOMES.

Value analysis committee product information kit

PREPERITONEAL PLACEMENT

Table of contents

PRODUCT OVERVIEWKey considerations 1 1Intended use 1 2Monofilament PTFE knit 1 2Optimum strength 1 3Bacterial adherence 1 4Ingrowth 1 5Effect of pore size 1 5Rapid cell migration and vascularization 1 7Shrinkage 1 8Handling 1 8

PRODUCT USE RECOMMENDATIONSProduct use recommendations 2 1Product replacement 2 2

VALUE ANALYSISOverview 3 1Economic 3 2Preclinical data 3 3Societal impact 3 5

MATERIALS MANAGEMENT INFORMATIONCatalogue numbers and size chart 4 1Product specifications 4 1Material composition 4 1Coding and reimbursement 4 1FDA clearance 4 2Instructions for use 4 4

REFERENCES 5 1

Product overview


Product overview

The GORE® SYNECOR Preperitoneal Biomaterial is an innovative hernia repair solution for advanced reconstruction

In single-stage preperitoneal repairs, the biomaterial offers permanent strength with rapid tissue ingrowth Through

these key advantages, risks may be reduced to achieve optimal outcomes:

Promote healing: Tissue building scaffold on each side promotes rapid vascularity and ingrowth:

vascularity demonstrated within seven days, tissue ingrowth within one month

Single-stage solution: Unique combination of proven technologies promotes 1:1 tissue generation and

lasting strength for challenging repairs

Minimize device removal: Vascularity within the device and the PTFE fiber design enable treatment options

Dedicated resources: Ongoing engagement from our team providing guidance, case support, education,

and training

GORE® SYNECOR Preperitoneal Biomaterial was designed with one purpose – Successful outcomes that provide value for:

Patients — A single surgery with faster recovery and fewer complications, versus a staged repair requiring multiple surgeries

Surgeons — A single-stage, durable repair in complex cases

Hospitals — Positive clinical outcomes with low cost in use

Payers — An efficient solution in complex cases, with an effective single procedure

The key considerations for your value analysis include:

1. The product

GORE® SYNECOR Preperitoneal Biomaterial is a cost-effective, easy-to-use hernia repair solution for onlay, retrorectus,

and preperitoneal placements It is a unique hybrid in combining permanent strength with a tissue-building scaffold

Construction features include:

• Two layers of GORE® BIO-A® Web — A tissue-building scaffold for rapid vascularity and ingrowth on both sides

• Latest generation macroporous knit of dense, monofilament PTFE fiber — May reduce the risk of harboring bacteria

due to the solid fiber and provide optimum strength for a durable, single-stage repair

2. Those who benefit

• General surgeons

• Plastic surgeons

• Trauma surgeons

3. The financial impact

• Lower cost in use versus biologic products of similar size, which are not intended for bridging and may require

additional surgery1,2

• Low cost of use compared to lightweight and mid-weight meshes that have clinical literature case studies

demonstrating failure due to inadequate strength in similar indications3–5

4. Impact on patient outcomes

• A single surgery with faster recovery and fewer complications, versus a staged repair requiring multiple surgeries

1.1


GORE® SYNECOR Preperitoneal Biomaterial is a unique combination of a macroporous knit of dense, monofilament PTFE

fibers embedded between two GORE® BIO-A® Web scaffolds, comprised of polyglycolic acid (PGA) and trimethylene

carbonate (TMC)

GORE® SYNECOR Preperitoneal Biomaterial combines long-term strength, with rapid tissue ingrowth and vascularization,

providing a single-stage, durable repair in complex cases

• Rapid vascularity and ingrowth — Features GORE® BIO-A® Web technology, a tissue-building scaffold

• Durable, single-stage repair — The macroporous knit of dense, monofilament PTFE fiber (which may reduce the risk of

harboring bacteria due to the solid fiber) provides optimum strength

Intended useGORE® SYNECOR Preperitoneal Biomaterial is intended for use in the repair of hernias and abdominal wall soft tissue

deficiencies that may require the addition of a non-absorbable reinforcing or bridging material

1.2

Product overview

GORE® BIO-A® Web

GORE® BIO-A® Web

PTFE Knit

Monofilament PTFE knitThe treatment of ventral hernias with prosthetic devices has reduced recurrence rates, but has led to questions

concerning infection Open hernia repair has been associated with infection rates from 3 to 18 percent 6 Laparoscopic

ventral hernia repair has been associated with lower incidence of infection 6 The PTFE knit is designed with a fiber

diameter similar to lightweight mesh but with the strength of a heavyweight mesh Thus, the PTFE knit can maintain

the surface area desired in lightweight materials, but not sacrifice strength as happens with polypropylene knits The

PTFE knit is designed from a dense, monofilament fiber, similar to polypropylene fibers The macroporous knit of dense,

monofilament PTFE fiber may reduce the risk of harboring bacteria due to the solid fiber

Macroporous knit of dense monofilament PTFE fiber

Polypropylene


Optimum strength

GORE® SYNECOR Preperitoneal Biomaterial is easy to handle, yet strong and compliant Strength is an obvious concern

when performing a structural repair, such as bridging a fascial defect in ventral hernia repair This has become critical as

patient body mass indices (BMIs) continue to increase A permanent biomaterial must be able to serve its intended use

over the life of the patient, without degradation or loss in strength

The macroporous, monofilament PTFE knit provides permanent strength when bridging a hernia or soft tissue defect

Testing has shown the PTFE within GORE® SYNECOR Preperitoneal Biomaterial to have a burst strength over 500 N

providing strength for large defects or BMIs (data on file 2016; W L Gore & Associates, Inc; Flagstaff, AZ)

1.3

Product overview

High strength and optimal porosity *,7

Literature suggests the strength requirement for bridging ventral hernia repair has an abdominal wall surface tension of

32 N / cm 8,9 A calculation is used to convert the 32 N / cm into a load of 255 N, which is measured using the international

standard ball burst test method for material strength, ASTM D3787

• Strength measurement for GORE® SYNECOR Preperitoneal Biomaterial is for knit component only; other product

measurements conducted on full construct out of the box

• Strength measurement for composite mesh products may be lower, once respective bioabsorbable components

are degraded

• Studies have shown that increasing pore size from medium to very large improved mechanical strength of tissue

ingrowth10 and reduced scar plate formation11

Bal

l bur

st s

tren

gth

(N

)

Equivalent32 N / cm Line

Improving tissue response

00

700

3Minimum pore size (mm)

Red

ucin

g ri

sk o

f rec

urre

nce

Equivalent47.8 N / cm Line9

Potential tensile strengthneeded for obese patients

BARD® Soft Mesh

ETHICON ULTRAPRO®

Partially Absorbable Lightweight Mesh

MEDTRONIC PARIETEX Optimized Composite Mesh

MEDTRONIC SYMBOTEXComposite Mesh

The macroporous knit of dense, monofilament PTFE fibers provide optimum strength for a durable, single-stage repair.

580N

1.59mm

* Data on file 2016; W L Gore & Associates, Inc; Flagstaff, AZ


Product overview

S. Aureus stains green; red represents the fiber materials as reflected light

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Partially absorbable lightweight polypropylene knit (10x)

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Polypropylene knit (10x)0.0

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Polyvinylidene / polypropylene knit(10x)GORE® SYNECOR Preperitoneal

Biomaterial PTFE knit (10x)0.0

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Bacterial adherence12

Bacterial adherence was examined among various materials, including the PTFE knit of GORE® SYNECOR Preperitoneal

Biomaterial and other various knits The materials were incubated in S. aureus overnight, rinsed, and subjected to

staining and analysis through confocal microscopy This allowed for analysis of where bacteria attached

Via confocal fluorescence imaging, the interaction of S. aureus to various knitted polymer materials were compared,

and it was concluded that:

• All bacteria are located only on the surface of the fibers for each type of polymer — PTFE, Polypropylene, and PVDF

• Bacteria localize to the knots and fiber surfaces of all the knits

• No bacteria were located within the PTFE knit

• Fewer bacteria were found on PTFE Knit fibers than other knits

Overall, bacteria localize to the knots and fiber surfaces of all test articles examined in this study Confocal images

suggest that no bacteria are located within the PTFE Knit fibers and overall fewer bacteria are located on PTFE Knit fibers

than other materials

1.4


Tissue ingrowthThe extent of ingrowth achieved for any device is influenced by the size of the pores within the scaffold While very

small pores may inhibit tissue ingrowth, larger pores encourage the ingrowth of new tissue13 (Figure 1)

• Nonporous = capsule• 5 and 60 μm pores = vascularized tissue surrounding implant• 700 μm pores = “pseudocapsules” around nodules

Typical tissue forming around the polyvinyl alcohol (PVA) implants. The implant is facing up from the bottom and the surrounding tissue is extending down from the top of each micrograph. Small blood vessels near the implant-tissue interface are indicated by small yellow arrows. Solid nodules of the PVA are indicated by large red arrowheads (original magnification x100). Note the dense tissue structure and relative avascularity of the (a) PVA-skin capsule. By contrast, the tissue response to the porous (b) PVA-5, and (c) PVA-60 implants is highly vascular, as noted by the abundance of small vessels, and comprises a less dense, more randomly oriented fibrous tissue structure. Note the pseudocapsules that form around each nodule of solid PVA in between the pores within the (d) PVA-700 implant.

Product overview

The two layers of GORE® BIO-A Web, which serve as the tissue-building scaffold in GORE® SYNECOR Preperitoneal

Biomaterial, provides optimal porosity for rapid cellular infiltration and vascularization (Figure 2) These two web layers,

on either side of the knit, form interconnected pores that are similar in structure to the collagen fiber network (Figure 3)

The PTFE knit layer of GORE® SYNECOR Preperitoneal Biomaterial is a macroporous construct of large pores; average

pore size is 1 59 mm (Figure 2) The web layer forms interconnected pores that are similar in structure to a collagen fiber

network (Figure 3)

≥ 1 mm

100 µm

10 µm

MACROPOROUS PTFE KNITTissue ingrowth device (macroporous)

GORE® BIO-A® WEB SCAFFOLDOPTIMAL PORE SIZE RANGE: Tissue ingrowth and tissue generating / angiogenic device with optimal porosity for cellular infiltration and vascularization

Engineering tissue response with material structure

The effect of pore size 13,14

Figure 1.

Figure 2.

Figure 3.

Collagen gel.

GORE® BIO-A® Web (GORE® BIO-A Tissue Reinforcement) (SEM 100x).

1.5

Small blood vessels near the implant-tissue interface

Solid nodules of the PVA


Product overview

Figure 4b – This section shows the GORE® SYNECOR Preperitoneal Biomaterial device (Web: black arrows, Fibers: F) filled completely with collagen, vessels (red arrows) and cells. 10x. HE. 30 days.

Tissue ingrowthThe combination of the GORE® BIO-A Web scaffold with the macroporous PTFE knit in GORE® SYNECOR Preperitoneal

Biomaterial allows for rapid cellular ingrowth and appropriate tissue integration Studies demonstrated that at 30 days,

bioabsorption of the GORE® BIO-A Web layers was evident (Figure 4a),15 and tissue ingrowth was present throughout the

GORE® SYNECOR Preperitoneal Biomaterial, around the knit fibers and within the web (Figure 4b) 15 The ingrowth was

vascularized, organized, and filled the macropores

Overall, this combination results in cellular migration and vascularization, which can facilitate healing after a hernia repair

1.6

Figure 4a – At 30 days, the GORE® BIO-A® Web layers (orange) shows some evidence of bioabsorption with aggregation of web fibers, the PTFE knit fibers are visible (blue).

30 DA

YS

HE POLARIZED

Fibrous Tissue ingrowth

GORE® SYNECOR Preperitoneal Biomaterial results• Organized to densely organized fibrous tissue ingrowth at 180 days


Product overview

Rapid cell migration and vascularization

GORE® SYNECOR Preperitoneal Biomaterial is a unique combination of a macroporous PTFE knit embedded between

two GORE® BIO-A® Web scaffolds The GORE® BIO-A® Web scaffold supports the rapid development of quality tissue

without the risks associated with biologics The web component of GORE® SYNECOR Preperitoneal Biomaterial is

designed to break down primarily by hydrolysis and provides uniformity and consistency

Vascularity within GORE® BIO-A® Web increases over time16

GORE® BIO-A® Web replaced by tissue at 1:1 ratio17

Within one to two weeks,

cells migrate into the

GORE® BIO-A® Web scaffold

and begin generating

vascularized soft tissue

3 7 14 30

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EFEC

T 100

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0Day of implant 3 Months* 6 Months*

GORE® BIO-A® WebCollagen

1.7

* Cells and blood vessels make up remaining volume


ShrinkageAll biomaterials, including polypropylene, polyester, and PTFE, will contract to some degree after implantation due to the

activity of myofibroblasts during wound healing Animal studies show GORE® SYNECOR Preperitoneal Biomaterial has

minimal shrinkage at 30 and 179 days 15,19

Product overview

Device Days in-life Change in area

GORE® SYNECOR Preperitoneal Biomaterial 30 +15.7%

179 -0.0%

Handling

• Pre-soaking is not required

• Absorbs fluids (i.e. blood); may be dipped in

sterile saline to facilitate handling

• Material memory facilitates optimal placement

• The material is appropriate for use during

robotic procedures

1.8

Supporting Patient Quality of Life

In the case of GORE® SYNECOR Preperitoneal Biomaterial, the product design supports the patient quality of life:

• Allows for a single surgery

• Enables fast recovery

• Allows for optimal outcomes

Vascularity is an important assessment to be made during the acute healing process of implanted mesh materials,

especially in complex abdominal wall repairs In addition, there is even more importance in evaluating the presence of

blood vessels throughout the device structure in the immediate postoperative time period

Assessing vascularity via microcomputed tomography (MicroCT), it was shown that as early as seven days post-implant, numerous newly formed blood vessels were observed, both around and within the GORE® SYNECOR Preperitoneal Biomaterial 18

Product use recom

mendations


GORE® SYNECOR Preperitoneal Biomaterial is intended for use in the repair of hernias and abdominal wall soft tissue

deficiencies that may require the addition of a nonabsorbable reinforcing or bridging material

The material is designed specifically for use in open, laparoscopic, and robotic procedures Hospital surgical

departments, including general surgery, trauma, and plastics find value in the material Some common applications include:

• Transversus abdominis release (TAR) procedure

• Component separation technique

• Preperitoneal ventral hernia repair

• High-risk ventral hernia repair

Product use recommendations

2.1


GORE® SYNECOR Preperitoneal Biomaterial is less than half the cost of leading biologics*, and cost is favorable compared to other biosynthetics 20 Based on patient selection criteria, clinicians may utilize GORE® SYNECOR Intraperitoneal Biomaterial

in place of the following products:

2.2

Product replacement

Company Product nameBiologic mesh

Biosynthetic mesh

Permanent mesh

Compositemesh**

Hybrid mesh†

ALLERGAN STRATTICE Reconstructive Tissue Matrix •ATRIUM PROLITE Mesh •ATRIUM VITAMESH •ATRIUM VITAMESH Blue •BARD® 3DMAX Light Mesh •BARD® 3DMAX Mesh •BARD® Soft Mesh •BARD® Mesh •BARD® XENMATRIX AB Surgical Graft •BARD® XENMATRIX Surgical Graft •BARD® DAVOL PHASIX Mesh •COOK® BIODESIGN® Advanced Tissue Repair •COOK® ZENAPRO® Hybrid Hernia Repair Device •ETHICON PROLENE® Soft Polypropylene Mesh •ETHICON PROLENE® Polypropylene Mesh •ETHICON

ULTRAPRO ADVANCED Macroporous Partially Absorbable Mesh •

ETHICON ULTRAPRO® Partially Absorbable Lightweight Mesh •ETHICON XCM BIOLOGIC® Tissue Matrix •INTEGRA® SURGIMEND® Collagen Matrix •KEBOMED DYNAMESH® -PP •MEDTRONIC PARIETEX Lightweight Monofilament Mesh •MEDTRONIC PARIETEX Flat Sheet Mesh •MEDTRONIC PERMACOL Surgical Implant •MEDTRONIC PROGRIP Laparoscopic Self-Fixating Mesh •MEDTRONIC VERSATEX Monofilament Mesh •NOVUS SCIENTIFIC TIGR® Matrix Surgical Mesh •RTI SURGICAL® TUTOMESH® Fenestrated Bovine Pericardium •RTI SURGICAL® TUTOPATCH® Bovine Pericardium •TELA BIO OVITEX Reinforced BioScaffold •

* © 2017 Millennium Research Group, Inc All rights reserved Reproduction, distribution, transmission or publication is prohibited Reprinted with permission

** Composite meshes are permanent mesh with an absorbable visceral protection layer

† Hybrid meshes have permanent mesh with a bioabsorbable (biologic or biosynthetic) tissue scaffold material

Value analysis


Payer

Provider

Physician

PatientCare

CareSatisfactionEase of useQuality outcomesSafety

ControlMaterial designPerformanceCostFitness for use

ContributeSupportTrainingEducationResearch

ControlContribute

Cost, quality, outcomes, patient quality of life, and societal benefits

Healthcare professionals understand that in order to deliver the best patient care possible, they will need to operate

beyond the intersection of cost, quality, and outcomes When choosing products for a hospital system, the focus is

changing from “cost of product” to the “total cost of care ” The cost of care extends well beyond surgery, to include

follow-up care, procedures, a return to the patient’s previous activities, and quality of life

Our analysis of value covers those comprehensive, multi-dimensional factors that we can control, thus providing us with

the ability to work with healthcare providers in delivering the greatest impact and value in patient care

3.1

Value analysis: Overview


Economic value and mesh selection for hernia repair

In hernia repair, the cost of the mesh or biomaterial

selected is only the first consideration, but it is

potentially very significant in determining value For

example, a synthetically made biosynthetic product

like GORE® SYNECOR Preperitoneal Biomaterial can

be less than half the cost of biologic meshes* and

provide a low cost in use compared to lightweight

synthetic meshes that have failed in clinical use due to

inadequate strength 3,4 GORE® SYNECOR Preperitoneal

Biomaterial can be used in place of biologic and

permanent synthetic meshes in clean and clean high-

risk patient types, while providing economic value

Even with biologics providing discounted contract

pricing, cost savings with biosynthetics must be

evaluated and considered as part of the value analysis

in clean high-risk patient types Clearly, the total cost of

care is the most critical factor in the value analysis

Proven results

GORE® SYNECOR Preperitoneal Biomaterial is comprised

of the same GORE® BIO-A Web Technology used in

GORE® BIO-A Tissue Reinforcement, a product backed

by documented success:

• Ten years of safe clinical use in complex ventral

hernia repair

• More than 150 publications

• Over 1,700 patients in the clinical literature

Since 2008, GORE® BIO-A® Tissue Reinforcement has

documented success and low recurrence rates in

hernia repair

Patient quality of life after hernia repair

Ventral hernia repairs have significant economic

ramifications for patients, employers, and insurers

because of the volume of procedures, complication

rates, the significant rate of recurrences, and escalating

costs Ventral hernia repairs in the United States are

estimated to cost at least $3 2 billion annually based

on 2006 data 21 Notably, the report also found that

every reduction in recurrence generates substantial

cost savings – each one percent reduction would save

about $32 million annually 21

3.2

Value analysis: Economic

Reynolds et al., with the University of Kentucky, evaluated their expenditure for surgical hernia meshes for ventral hernia wall repair at a tertiary care referral facility.22

Losses were greatest in cases involving use of biologic mesh, which resulted in a median net financial loss of $8,370.00. Biologic mesh more than doubled the direct costs of incisional hernia repair.22

Surgical mesh units22 Surgical mesh costs22

Synthetic mesh Biologic mesh$1,000

$0

($1,000)

($2,000)

($3,000)

($4,000)

($5,000)

($6,000)

($7,000)

($8,000)

($9,000) ($8,370)

$60 100%

Net profit

Request a custom cost analysis

In hernia surgery, total cost of care can vary widely if

complications occur To see how the cost of complications can

affect your hospital’s bottom line, schedule a brief discussion

with your local Gore sales associate for a custom value

analysis To contact your local Gore sales associate, please call 1.888.925.4673.

* © 2017 Millennium Research Group, Inc All rights reserved Reproduction, distribution, transmission or publication is prohibited Reprinted with permission


Total cellular ingrowth23

0

1

2

3

4

5

6

7 14 30 60 90 180days

grad

e

GORE® BIO-A® Tissue Reinforcement

ETHICON FLEXHD® Acellular Hydrated Dermis

ALLERGAN STRATTICEReconstructive Tissue MatrixMEDTRONIC PERMACOLSurgical Implant

Value analysis: Preclinical data

GORE® BIO-A® Web TechnologyThe same bioabsorbable web layers in GORE® SYNECOR Preperitoneal Biomaterial have proven clinical data in

GORE® BIO-A® Tissue Reinforcement GORE® BIO-A® Tissue Reinforcement, solely comprised of GORE® BIO-A® Web Technology, exhibited a higher degree of cellular and vascular ingrowth and collagen deposition than three commonly

used biologic meshes in a sterile field The use of a polyglycolic acid / trimethylene carbonate absorbable mesh results

in a favorable tissue response 23

3.3

In figures above, Herovici stain compares new collagen deposition (blue) at 30 days 23

Figure 1A. GORE® BIO-A® Tissue Reinforcement. Figure 1B. ETHICON FLEXHD® Acellular Hydrated Dermis for Hernia Repair.


Ingrowth

The combination of the GORE® BIO-A® Web scaffold and the PTFE knit

allows for rapid cellular ingrowth and appropriate tissue integration

without negatively affecting abdominal wall compliance typically

associated with heavyweight polypropylene meshes

Studies demonstrated that at 30 days15 tissue ingrowth was present

throughout the device with various densities around the knit fibers and

within the web The ingrowth was vascularized, organized, and filled

the macropores This section shows the GORE® SYNECOR Preperitoneal Biomaterial device (Web: black arrows, Fibers: F) filled completely with collagen, vessels (red arrows) and cells. 10x. HE. 30 days 15

Value analysis: Preclinical data

3.4

Assessing vascularity via microcomputed tomography (MicroCT), it was shown that as early as seven days post implant, numerous newly formed blood vessels were observed both around and within the GORE® SYNECOR Preperitoneal Biomaterial 18

Human fibroblast cells grow into GORE® SYNECOR Preperitoneal Biomaterial scaffold The web layer is designed to encourage cellular penetration and ingrowth of the device The in vitro analysis demonstrated

penetration of human fibroblast cells into the web scaffold of the device Overall, the rendering demonstrates

penetration of fibroblasts throughout the web of GORE® SYNECOR Preperitoneal Biomaterial at eight days

Rapid vascularityVascularity is an important assessment to be made during the acute

healing process of implanted mesh materials, especially in complex

abdominal wall repairs In addition, there is even more importance

in evaluating the presence of blood vessels throughout the device

structure in the immediate postoperative time period 18

Green: fibroblast

Blue: nuclei and bioabsorbable fibers

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Environmental benefitsGORE® SYNECOR Preperitoneal Biomaterial is synthetically made in a controlled environment The product does not

utilize human or animal-derived tissue, so there is no risk of cell, disease, or virus transmission

Patient benefits• No human / animal-derived tissue alleviates concern or need for patient discussion to consider religious beliefs or

cultural practices regarding the use of certain animals or their body parts24

• Allows for a single surgery

• Faster recovery

• Fewer complications

• Helps avoid a staged repair requiring multiple surgeries

Community benefitsGORE® SYNECOR Preperitoneal Biomaterial was designed with one purpose – Successful outcomes that provide value for:

Patients — A single surgery with faster recovery and fewer complications, versus a staged repair requiring

multiple surgeries

Surgeons — A single-stage, durable repair in complex cases

Hospitals — Positive clinical outcomes with low cost of use

Payers — An efficient solution in complex cases, with an effective single procedure

The key considerations for your value analysis include:1. The product

GORE® SYNECOR Preperitoneal Biomaterial is a cost-effective, easy-to-use hernia repair solution for onlay, retrorectus,

and preperitoneal placements It is a unique hybrid in combining permanent strength with a tissue-building scaffold

Construction features include:

• Two layers of GORE® BIO-A® Web — A tissue-building scaffold for rapid vascularity and ingrowth on both sides

• Latest generation macroporous knit of dense, monofilament PTFE fiber — May reduce the risk of harboring bacteria

due to the solid fiber, and provides optimum strength for a durable, single-stage repair

2. Those who benefit• General surgeons

• Plastic surgeons

• Trauma surgeons

3. The financial impact• Low cost of use in comparison to biologic products of similar size, which also may require an additional surgery

as they are not intended for bridging1,2

• Low cost of use compared to lightweight and mid-weight meshes that have clinical literature case studies demon-

strating failure due to inadequate strength in similar indications3–5

4. Impact on patient outcomes A single surgery with faster recovery and fewer complications, versus a staged repair requiring multiple surgeries

3.5

Value analysis: Societal impact

Materials m

anagement

information


Product configuration and sizing

Product specifications

The GORE® SYNECOR Preperitoneal Biomaterial device is intended for use in the repair of hernias and abdominal wall

soft tissue deficiencies that may require the addition of a nonabsorbable reinforcing or bridging material

Material composition

GORE® SYNECOR Preperitoneal Biomaterial is a composite mesh comprised of a non-absorbable macroporous knit

constructed of monofilament PTFE fibers between two layers of bioabsorbable material The bioabsorbable layers

are a synthetic porous fibrous structure comprised of poly (glycolide:trimethylene carbonate) copolymer (PGA:TMC)

GORE® SYNECOR Preperitoneal Biomaterial is designed for preperitoneal placement and should be placed between

tissue layers where ingrowth is desired

Additionally, GORE® SYNECOR Preperitoneal Biomaterial does not require any precertification for use, but we do offer

peer-to-peer education courses for surgeons, residents, fellows, nursing staff, value analysis committees, or other

administrators To learn more, please contact your local Gore sales associate or call 1.888.925.4673

Coding and reimbursement

For a coding and reimbursement guide, visit goremedical com/synecorpre

Catalogue number Description

GKWV1015 10 cm x 15 cm oval

GKWR1215 12 cm x 15 cm rectangle

GKWV1520 15 cm x 20 cm oval



G = GoreK = KnitW=WebV = OvalR = Rectangle

4.1

Materials management information


4.2

FDA clearance


4.3

FDA clearance


GORE® SYNECOR Preperitoneal Biomaterial

INDICATIONS The GORE® SYNECOR Preperitoneal Biomaterial device is intended for use in the repair of hernias and abdominal wall soft tissue deficiencies that may require the addition of a non-absorbable reinforcing or bridging material

CONTRAINDICATIONS Not for reconstruction of cardiovascular defects

DESCRIPTION GORE® SYNECOR Preperitoneal Biomaterial is a composite mesh comprised of a non-absorbable macroporous knit constructed of monofilament PTFE fibers between two layers of bioabsorbable material The bioabsorbable layers are a synthetic porous fibrous structure comprised of poly (glycolide:trimethylene carbonate) copolymer (PGA:TMC) GORE® SYNECOR Preperitoneal Biomaterial is designed for preperitoneal placement and should be placed between tissue layers where ingrowth is desired

STERILITY GORE® SYNECOR Preperitoneal Biomaterial is sterilized by ethylene oxide and supplied STERILE Provided that the integrity of the package is not compromised in any way, the package will serve as an effective barrier until the “use by” (expiration) date printed on the box

GORE® SYNECOR Preperitoneal Biomaterial is designed for single use only; do not reuse device Gore does not have data regarding reuse of this device Reuse may cause device failure or procedural complications including device damage, compromised device biocompatibility, and device contamination Reuse may result in infection, serious injury, or patient death

Recommended Techniques

HANDLING Use clean, sterile gloves and/or atraumatic instruments when handling GORE® SYNECOR Preperitoneal Biomaterial

PREPARATION GORE® SYNECOR Preperitoneal Biomaterial does not require pre-wetting If desired, GORE® SYNECOR Preperitoneal Biomaterial may be wetted with sterile saline or similar standard irrigation solution prior to placement to facilitate introduction It is recommended that the device be placed next to well-vascularized tissue

LAPAROSCOPIC USE Removing the trocar seal can help facilitate deployment Ease of introduction may vary depending on rolled device size and trocar variability See Table 1 for the minimum recommended trocar size

TABLE 1: MINIMUM RECOMMENDED TROCAR SIZE

DEVICE SIZE

MINIMUM RECOMMENDED TROCAR SIZE

10 cm x 15 cm 10 mm

12 cm x 15 cm 11 mm

15 cm x 20 cm 12 mm

20 cm x 25 cm 15 mm

20 cm x 30 cm* 15 mm

* Recommended wetting for ease of introduction

SIZING AND USE Cutting GORE® SYNECOR Preperitoneal Biomaterial to the proper size is essential Use sharp surgical instruments to trim the mesh to ensure overlap of the defect on all sides Reported standard of care is 5 cm or greater

If GORE® SYNECOR Preperitoneal Biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect

SUTURE FIXATION Nonabsorbable sutures, such as GORE-TEX® Suture (with taper or piercing point needle), of appropriate size are recommended to secure the mesh The use of absorbable sutures may lead to inadequate anchoring of GORE® SYNECOR Preperitoneal Biomaterial to the host tissue and necessitate reoperation

For best results, use monofilament sutures Suture size should be determined by surgeon preference and the nature of the reconstruction

When suturing GORE® SYNECOR Preperitoneal Biomaterial to the host tissue, the mesh should be sutured a minimum distance of 1 cm (0 4") from the edge of the device

Interrupted sutures can provide additional security against recurrence due to suture failure

4.4

Instructions for use

PGA/TMC Web

PTFE Knit

PGA/TMC Web


ADDITIONAL / ALTERNATIVE FIXATION Permanent staples or helical tacks (also known as helical coils) can be used as an alternative to sutures Staple size and staple or tack spacing should be determined by surgeon preference to provide for adequate tissue fixation and to prevent reherniation

Use of absorbable tack and staple fixation devices with GORE® SYNECOR Preperitoneal Biomaterial has shown to be compatible

Fixation methods other than those described above have not been evaluated for use with GORE® SYNECOR Preperitoneal Biomaterial

All fixation devices should be used in accordance with the manufacturer’s instructions for use and the physician should reference the manufacturer’s instructions for use and any supporting clinical literature regarding any potential adverse reactions related to fixation devices

WARNINGS • Strict aseptic techniques should be followed When

operative infection is suspected, dissection of involved tissues should be considered If an infection develops, it should be treated aggressively An unresolved infection may require removal of the material

• As with any mesh, use of GORE® SYNECOR Preperitoneal Biomaterial in contaminated fields may require removal of the mesh if infection occurs

• When using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary

• Use of this product in applications other than those indicated has the potential for serious complications

• Transvaginal insertion techniques, which expose the biomaterial to the vaginal flora, can increase the risk of contamination leading to colonization of the biomaterial Prolonged exposure to bacteria may necessitate material removal

• Clinical data has shown that use of any surgical mesh in transvaginal pelvic organ prolapse procedures could result in complications, including, but not limited to, mesh exposure, mesh erosion, pelvic pain, fistula formation, dyspareunia, infection, vaginal bleeding or discharge, vaginal dysfunction, or recurrence, which may require additional surgery A positive risk benefit profile for surgical mesh used in transvaginal pelvic organ prolapse repair is not well established in published literature, therefore this technique is not recommended for this device

PRECAUTIONS • Use of GORE® SYNECOR Preperitoneal Biomaterial in infants,

children or pregnancy where future growth will occur has not been evaluated

• Ensure the size of the mesh is adequate for the intended repair

• Do not use absorbable sutures to secure the mesh in place

• Do not resterilize the GORE® SYNECOR Preperitoneal Biomaterial

• Placing the PGA: TMC porous web adjacent to serosal tissue, such as the bowel, may result in adhesions Clinical data on abdominal surgery, with or without surgical mesh, has shown that adhesion formation may occur and may result in complications including pain, bowel obstruction, and additional intervention including surgery

ADVERSE REACTIONS Possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, pain, exposure (extrusion), bowel obstruction and recurrence

As with any surgical procedure, there are always risks of complications for surgical repair of hernias, with or without mesh, these may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision / resurgery, device contraction, fever, hernia recurrence

4.5

Instructions for use

References


1 Blatnik J, Jin J, Rosen M Abdominal hernia repair with bridging acellular dermal matrix—an expensive hernia sac American Journal of Surgery 2008;196:47–50

2 Giordano, S , Garvey, P B , Baumann, D P , Liu, J , & Butler, C E (2017) Primary fascial closure with biologic mesh reinforcement results in lesser complication and recurrence rates than bridged biologic mesh repair for abdominal wall reconstruction: A propensity score analysis Surgery 161(2),499-508

3 Petro CC, Nahabet EH, Criss CN, et al. Central failures of lightweight monofilament polyester mesh causing hernia recurrence: a cautionary note Hernia 2015;19(1):155-159

4 Cobb WS, Warren JA, Ewing JA, Burnikel A, Merchant M, Carbonell AM Open retromuscular mesh repair of complex incisional hernia: predictors of wound events and recurrence Journal of the American College of Surgeons 2015;220(4):606-613

5 Warren JA, McGrath SP, Hale AL, Ewing JA, Carbonell AM 2nd, Cobb WS 4th Patterns of recurrence and mechanisms of failure after open ventral hernia repair with mesh American Surgeon 2017;83(11):1275-1282

6 LeBlanc KA, Heniford BT, Voeller GR Innovations in ventral hernia repair Materials and techniques to reduce MRSA and other infections Contemporary Surgery 2006;62(4) Supplement:1-8

7 Olson TB Competitive Hernia Device Strength Evaluation. Flagstaff, AZ: W L Gore & Associates, Inc; 2016 [Work plan] WP108484

8 Klinge U, Klosterhalfen B, Conze J, et al. Modified mesh for hernia repair that is adapted to the physiology of the abdominal wall European Journal of Surgery 1998;164(12):951-960

9 Zhu LM, Schuster P, Klinge U Mesh implants: an overview of crucial mesh parameters World Journal of Gastrointestinal Surgery 2015;7(10):226-236

10 Lake SP, Ray S, Zihni AM, Thompson DM Jr, Gluckstein J, Deeken CR 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 2015;42:186-197

11 Klinge U, Klosterhalfen B, Birkenhauer V, Junge K, Conze J, Schumpelick V Impact of polymer pore size on the interface scar formation in a rat model Journal of Surgical Research 2002;103(2):208-214

12 Clinger L PTFE Knit Microbial Placement Flagstaff, AZ: W L Gore & Associates, Inc; 2018 [Work plan] WP110158

13 Sharkawy AA, Klitzman B, Truskey GA, Reichert WM Engineering the tissue which encapsulates subcutaneous implants, II Plasma-tissue exchange properties Journal of Biomedical Materials Research 1998;40(4):586-597

14 Rosengren A, Bjursten LM Pore size in implanted polypropylene filters in critical for tissue organizaiton Journal of Biomedical Materials Research Part A 2003;67(3):918-926

15 Berman A Evaluation of Plexus without film and ETHICON PHYSIOMESH® in a 30-day rabbit subcutaneous model Flagstaff, AZ: W L Gore & Associates, Inc; 2015 [Corporate protocol] 2336SC

16 Berman A A Rabbit Model for the Biomechanical and Histological Assessment of Suture Line Wound Healing. Flagstaff, AZ: W L Gore & Associates, Inc ; 2008 [Corporate protocol] 1978SC

17 Morales-Conde S, Flores M, Fernández V, Morales-Méndez S Bioabsorbable vs. polypropylene plug for the “Mesh and Plug” inguinal hernia repair. Presented at the 9th Annual Meeting of the American Hernia Society; February 9-12, 2005; San Diego, CA Flagstaff, AZ: W L Gore & Associates, Inc; 2005 [Poster] AJ0049-EN2

18 Crawford N Assessment of Vascularity via Micro CT in Various Patch Devices. Flagstaff, AZ: W L Gore & Associates, Inc; 2016 [Final study report] 2344TL

19 Berman A Evaluation of Plexus without film and ETHICON PHYSIOMESH® in a 180-day rabbit subcutaneous model. Flagstaff, AZ: W L Gore & Associates, Inc; 2015 [Corporate protocol] 2338SC

20 Kim M, Oommen B, Ross SW, et al. The current status of biosynthetic mesh for ventral hernia repair Surgical Technology International 2014;25:114-121

21 Poulose BK, Sherlton J, Phillips S, et al. Epidemiology and cost of ventral hernia repair: making the case for hernia research Hernia 2012;169(2):179-183

22 Reynolds D, Davenport DL, Korosec RL, Roth S Financial implications of ventral hernia repair: a hospital cost analysis Journal of Gastrointestinal Surgery 2013;17(1):159-167

23 Zemlyak AY, Colavita PD, Tsirline VB, et al. Absorbable glycolic acid/trimethylene carbonate synthetic mesh demonstrates superior in-growth and collagen deposition Presented at the Abdominal Wall Reconstruction (AWR) Meeting; June 14-16, 2012; Washington, DC Abstract 35

24 Jenkins ED, Yip M, Melman L, Frisella MM, Matthews BD Informed consent: cultural and religious issues associated with the use of allogeneic and xenogeneic mesh products Journal of the American College of Surgeons 2010;210(4):402-410

References

5.1

W. L. Gore & Associates, Inc.Flagstaff, AZ 86004

+65 67332882 (Asia Pacific) 800 437 8181 (United States)00800 6334 4673 (Europe) 928 779 2771 (United States)

goremedical.com

Refer to Instructions for Use for a complete description of all warnings, precautions, and contraindications

Products listed may not be available in all markets

ALLERGAN and STRATTICE are trademarks of Allergan, Inc ATRIUM, PROLITE and VITAMESH are trademarks of Atrium Medical Corporation BARD®, COMPOSIX, DULEX, SEPRAMESH, VENTRALIGHT, VENTRIO, and XENMATRIX are trademarks of C R Bard, Inc DAVOL and PHASIX are trademarks of Davol, Inc , a subsidiary of C R Bard, Inc COOK®, BIODESIGN®, and ZENAPRO® are trademarks of Cook Medical ETHICON, FLEXHD®, PHYSIOMESH®, PROLENE®, ULTRAPRO®, ULTRAPRO ADVANCED, and XCM BIOLOGIC® are trademarks of Ethicon, Inc INTEGRA and SURGIMEND® are trademarks of Integra LifeSciences Corporation KEBOMED and DYNAMESH® are trademarks of KEBOMED MEDTRONIC, PARIETEX, PERMACOL, PROGRIP, and VERSATEX are trademarks of Medtronic, Inc NOVUS SCIENTIFIC and TIGR® are trademarks of Novus Scientific RTI SURGICAL, TUTOMESH® and TUTOPATCH® are trademarks of RTI Surgical, Inc

GORE®, BIO-A®, SYNECOR, and designs are trademarks of W L Gore & Associates © 2018 W L Gore & Associates, Inc AV0684-EN3 AUGUST 2018

Documents

OUTCOMES. Value analysis committee