Endo GIA Reinforced Reload

with Tri-Staple Technology

™

Product Information Kit

The reinforcement
is preloaded.
The confidence is built in.
2
 Table of Contents
Product Information
4 Product Introduction
5 Features & Benefits
6 Value Proposition
7 Tri-Staple™ Technology Overview

Competitive Information
8 Cross Reference Charts

11 Material Properties

12 Competitive Comparison

Technical Data
13 Bench Top & Pre-Clinical Testing

20 Histopathology

23 Post Market Study

Materials Management
Information & Forms
24 510(k) Clearance

26 Instructions For Use

4
The reinforcement
is preloaded.
The confidence is built in.

Covidien’s new Endo GIA™ Reinforced Reload with Tri-Staple™ technology

delivers an added measure of confidence without any additional steps.

The synthetic material is absorbent and soft which may improve clinical

outcomes – while the preloaded feature saves time and waste in the OR 1.

1."Survey of tissue reinforcement users to determine waste and time loss attributed to separately loaded buttress materials in the OR."
Online U.S. national sample of 125 surgeons and 125 OR nurses. Covidien-sponsored study by ORC International, 11/9/11.
3
 Product Introduction

New anvil and knife with every firing

Each reload has a fresh new knife for a clean and
precise transection of the material and tissue; and
Loading unit interchangeability a new anvil for quality staple formation.
Reinforced Reload with Tri-Staple™
technology can be used on all Endo GIA™
manual and powered handles.

Anchoring sutures
Keeps the material flat and secure when
manipulating the reload and firing.

Sleek design of material on each

cartridge and anvil
Compressible so material secured on each
anvil and cartridge.

Synthetic and absorbable

Synthetic material provides strength during
critical wound healing period and fully
absorbs after 15 weeks.1

Articulation
Offers improved access/visualization
Preloaded reinforcement material on each
to the surgical site.
anvil and cartridge
No extra handling of the reinforcement
material. Simple and easy-to-use.

1. Reinforced Reload Pre-Clinical Testing, In-Vitro Mass Loss; Report: In vitro Mass Loss; 1/23/14 (2183-060-0).

4
 Features & Benefits

Feature Benefit Competitive Differentiation

No extra steps – easy to use and load vs. other

Other buttress materials have to be loaded
Preloaded material available buttress options
separately – adding potential for time and waste
NOTE: The only preloaded material available

Keep material flat and secure when manipulating Other buttress materials rely on gel, adhesive or
Anchoring sutures
the reload strings to ensure placement on reload

• Soft, absorbent and compressible

Similar composition to other synthetic material
• Strength during critical wound healing
Non-woven polymer (i.e., GORE®*); no animal derivative
period
(i.e., Baxter/Cook®*)
• Non-biologic

Competitive buttress products are thicker and

The thinnest buttress on the market, the compressible have a larger impact on the maximum tissue
<0.4 mm material thickness uniform material offers as large a tissue gap as thickness. GORE®* SEAMGUARD®* is up to 0.5
possible mm thick, while Baxter's material is between
0.4 - 1.2 mm thick1

Contrast color of material vs. Easy to inspect the transected tissue and staple line Other buttress materials are white or
live tissue integrity after placement transparent on tissue

1. Per manufacturer (GORE™*/Baxter) IFU.

5
 Value Proposition

Simple and easy to use with no extra loading steps

Having Reinforced Reload already preloaded with the buttress material may save
time, money and improve OR efficiency1. The material on the Reinforced Reload will
remain flat and secure when placed through a port or otomy and on the tissue prior
to firing.

Clinically used material that meets customer needs

The preloaded buttress is a synthetic polymer material that is compressible, soft,
pliable and absorbent. The non-woven material allows cellular infiltration and tissue
in-growth, an important process during wound healing 2.

Covidien has extensively evaluated the Reinforced Reload and invested in thoracic
and abdominal survival studies, proving statistical equivalence to SEAMGUARD®* with
respect to impact on adjacent tissues during post-operative healing3.

All the benefits of Tri-Staple™ technology

The Endo GIA™ Reinforced Reload includes Tri-Staple™ technology and all of the
benefits of its unique design. With its stepped cartridge face, Tri-Staple™ technology
optimizes interaction between the tissue and stapler. It generates less stress on tissue
during compression and clamping4, may allow greater perfusion into the staple line5
and provides outstanding performance in variable tissue thicknesses.

The Endo GIA™ Reinforced Reload with Tri-Staple™ technology will be available in four
sizes: 45 mm and 60 mm Purple Endo GIA™ Reinforced Reload and 45 mm and 60 mm
Black Endo GIA™ Reinforced Reload.

Ordering Information
Reorder Code Description Cartridge Color Staple Size (inner to outer row)
EGIATRS45AMT Endo GIA Reinforced Reload with Tri-Staple Technology 45 mm Articulating Medium Thick
™ ™
Purple 3 mm, 3.5 mm, 4 mm
EGIATRS60AMT Endo GIA™ Reinforced Reload with Tri-Staple™ Technology 60 mm Articulating Medium Thick Purple 3 mm, 3.5 mm, 4 mm
EGIATRS45AXT Endo GIA Reinforced Reload with Tri-Staple Technology 45 mm Articulating Extra Thick
™ ™
Black 4 mm, 4.5 mm, 5 mm
EGIATRS60AXT Endo GIA™ Reinforced Reload with Tri-Staple™ Technology 60 mm Articulating Extra Thick Black 4 mm, 4.5 mm, 5 mm

1."Survey of tissue reinforcement users to determine waste and time loss attributed to separately loaded buttress materials in the
OR." Online U.S. national sample of 125 surgeons and 125 OR nurses. Covidien-sponsored study by ORC International, 11/9/11.
2. 2183-089 Histology Results-Thoracic GLP (R0058122). 2183-090 Histology Results-Abdominal GLP (R0058123).
3. Reinforced Reload Pre-Clinical Testing, Abrasion Assessment of Staple Line Reinforcement Materials in the Thorax of a Canine,
4/4/13, Report #2183-027; Reinforced Reload Pre-Clinical Testing, Substantial Equivalence Chronic Study between Neoveil™* and
SEAMGUARD ®* in the Abdominal Cavity of Canines, 5/9/13, Report #2183-034.
4. When compared to Echelon Flex green reloads as part of a September 2, 2011 analysis comparing different stapler designs and
their performance and impact on tissues under compression using two-dimensional finite element analysis.
5. When compared to Ethicon Echelon Flex™* green reloads as part of a bench study conducted August 16-18, 2011 that measured
fluid perfusion into clamped media among different stapler designs (Covidien Engineering Report No. PCR-007).

6
 Tri-Staple™ Technology Overview

Preserving tissue integrity is the ultimate premise behind the advanced Tri-Staple™
technology design. Tri-Staple™ technology reloads are designed to work in harmony
with the natural properties of tissue to optimize performance before, during and
after stapling.

Vascular/Medium Tissue Reload* Medium/Thick Tissue Reload* Extra-Thick Tissue Reload*

2.0 mm Stepped 3.0 mm Stepped 4.0 mm Stepped
2.5 mm 3.5 mm 4.5 mm
cartridge face cartridge face cartridge face
3.0 mm 4.0 mm 5.0 mm

Universal Platform
iDrive™ Ultra & Endo GIA Ultra Universal Handle
TM

One Size Fits All Reloads

Endo GIA™ Reinforced

Reload Family

Delivering Results To The Bottom Line 14% Fewer Handles Used

when Compared to Ethicon1
Achieve SKU Standardization via Tri-Staple™ technology
and the universal handle platform. 69% Total SKU Reduction2
Based on national annual usage reported by IMS (July 2010 – June 2011).
37% Reduction In Stock Levels3
37% Reduction in Inventory Footprint2
54% Reduction in Excess Waste2

*Products depicted are not actual size.

1. Handle waste reduction calculation based on number of handles used for 500 total cases between July 2010 – July 2011
for Ethicon and Covidien respectively. Assumes 1 Covidien handle needed per case.
2. Total SKU reduction, inventory and waste based on national annual Covidien and Ethicon reload and handle usage reported
by IMS (July 2010-2011).
3. Assumes a 2-5 day supply of product in storage, based on focus group research findings during the August 2011
meeting of The Association of Healthcare Resource and Materials Management (AHRMM).
7
 Cross Reference Charts

Competitive Products Overview

In the spirit of partnership, and to facilitate the process of comparing pricing, we have provided the order codes for other products,
should you wish to cross-reference them.

Primary Competition
W.L. GORE®* SEAMGUARD®* BIOABSORBABLE STAPLE LINE REINFORCEMENT
This synthetic, absorbable tissue reinforcement’s sleeves (“socks”) are held by a non-absorbable polyester braided suture and increase
thickness of tissue by up to 0.5 mm.
GORE®* SEAMGUARD®* Product Codes
Recommended Covidien GORE®* SEAMGUARD®* GORE®* SEAMGUARD®*
Replacement Products Staple Line Reinforcement Bioabsorbable Staple Line Reinforcement
OPEN Linear Staplers
ILA™ 75 EGIATRS60AMT OR EGIATRS60AXT ASGS002
(Note length is 15 mm shorter)
Multifire GIA™ 80 EGIATRS60AMT OR EGIATRS60AXT ASGS002
(Note length is 20 mm shorter)
Multifire GIA™ 60 EGIATRS60AMT OR EGIATRS60AXT ASGS003
Covidien (Note length is 30 mm short)
GIA™ 90 Premium EGIATRS60AMT OR EGIATRS60AXT ASGS004
(Note length is 30 mm short)
DST GIA 60™
EGIATRS60AMT OR EGIATRS60AXT 10BSGDST60 12OBSGDST60†
DST GIA™ 80 EGIATRS60AMT OR EGIATRS60AXT 10BSGDST80 12OBSGDST80†
(Note length is 20 mm short)
Proximate®* 75 EGIATRS60AMT OR EGIATRS60AXT ASGS002 10BSGPROX75 12BSGPROX75†
(Note length is 15 mm shorter)
Proximate®* 55 EGIATRS60AMT OR EGIATRS60AXT ASGS003 10BSGPROX55 12BSGPROX55†
Ethicon
(Note length is 5 mm longer)
Proximate®* 100 EGIATRS100AMT OR EGIATRS100AXT 10BSGPROX100 12BSGPROX100†
(Note length is 5 mm longer)

ENDOSCOPIC Linear Staplers

Endo GIA™ II 30 3.5 mm EGIATRS45AMT SGS030R
Endo GIA™ II 45 3.5 mm EGIATRS45AMT SGS031R
Endo GIA II 60 3.5 mm
™
EGIATRS60AMT SGS032R
Endo GIA™ II 45 4.8 mm EGIATRS45AXT SGS034R
Endo GIA II 60 4.8 mm
™
EGIATRS60AXT SGS035R
Endo GIA™ Universal 45 2.5 mm N/A (coming soon) 1BSGUSS45B 12BSGUSS45B†
Endo GIA™ 45 mm Tan Reloads with N/A (coming soon) 1BSGUSS45B 12BSGUSS45B†
Tri-Staple™ Technology
Endo GIA™ Universal 45 3.5 mm EGIATRS45AMT 1BSGUSS45B 12BSGUSS45B†
Endo GIA 45 mm Purple Reloads
™
EGIATRS45AMT 1BSGUSS45B 12BSGUSS45B†
with Tri-Staple™ Technology
Covidien
Endo GIA™ Universal 45 4.8 mm EGIATRS45AXT 1BSGUSS45G 12BSGUSS45G†
Endo GIA 45 mm Purple or Black
™
EGIATRS45AMT OR EGIATRS45AXT 1BSGUSS45G 12BSGUSS45G†
Reloads with Tri-Staple™ Technology
Endo GIA™ Universal 60 2.5 mm N/A (coming soon) 1BSGUSS60B 12BSGUSS60B†
Endo GIA 60 mm Tan Reloads with
™
N/A (coming soon) 1BSGUSS60B 12BSGUSS60B†
Tri-Staple™ Technology
Endo GIA™ Universal 60 3.5 mm EGIATRS60AMT 1BSGUSS60B 12BSGUSS60B†
Endo GIA™ 60 mm Purple Reloads EGIATRS60AMT 1BSGUSS60B 12BSGUSS60B†
with Tri-Staple™ Technology
Endo GIA™ Universal 60 4.8 mm EGIATRS60AXT 1BSGUSS60G 12BSGUSS60G†
Endo GIA™ 60 mm Purple or Black EGIATRS60AMT OR EGIATRS60AXT 1BSGUSS60G 12BSGUSS60G†
Reloads with Tri-Staple™ Technology
EZ45 EGIATRS45AMT OR EGIATRS45AXT SGS021R 1BSGEZ45 12BSGEZ45†
ETS 45 EGIATRS45AMT OR EGIATRS45AXT SGS022R 1BSGETS45 12BSGETS45†
Ethicon
ETS Flex™* 60 EGIATRS60AMT OR EGIATRS60AXT 1BSGETS60 12BSGETS60†
Echelon™* 60 EGIATRS60AMT OR EGIATRS60AXT 1BSGEC60 12BSGEC60†

8 †12 packages per box

 Cross Reference Charts

BAXTER PERI-STRIPS DRY®* WITH VERITAS®* COLLAGEN MATRIX

This tissue reinforcement is prepared from bovine pericardium (U.S. cattle), is attached to the stapler reload by gel and increases
thickness of tissue by 0.4 mm to 1.2 mm.

Baxter Peri-Strips Dry®* Product Codes

Peri-Strips Dry®* with Veritas®*

Collagen Matrix
PSD-V 2 Firing PSD-V 6 Firing
OPEN Linear Staplers
GIA™ 80 EGIATRS60AMT OR EGIATRS60AXT PSD 8002-U-V PSD 8006-U-V
(Note length is 30 mm short)
GIA™ 90 EGIATRS60AMT OR EGIATRS60AXT PSD 9002-U-V PSD 9006-U-V
(Note length is 30 mm short)
DST GIA™ 60 EGIATRS60AMT OR EGIATRS60AXT PSD 6002-U-DST-V PSD 6006-U-DST-V
DST GIA™ 80 EGIATRS60AMT OR EGIATRS60AXT PSD 8002-U-DST-V PSD 8006-U-DST-V
(Note length is 20 mm short)
DST GIA™ 100 EGIATRS60AMT OR EGIATRS60AXT PSD 8002-U-DST-V PSD 8006-U-DST-V
Covidien (Note length is 40 mm short)
ILA™ 52 EGIATRS60AMT OR EGIATRS60AXT PSD 5502-E-V PSD 5506-E-V
(Note length is 8 mm longer)
ILA™ 75 EGIATRS60AMT OR EGIATRS60AXT PSD 7502-E-V PSD 7506-E-V
(Note length is 15 mm shorter)
ILA™ 100 EGIATRS60AMT OR EGIATRS60AXT PSD 10002-E-V PSD 10006-E-V
(Note length is 40 mm short)
PI™ 90 EGIATRS60AMT OR EGIATRS60AXT PSD 9002-PI-V PSD 9006-PI-V
(Note length is 30 mm short)
Proximate®* 55 EGIATRS60AMT OR EGIATRS60AXT PSD 5502-E-V PSD 5506-E-V
(Note length is 5 mm long)
Proximate®* 75 EGIATRS60AMT OR EGIATRS60AXT PSD 7502-E-V PSD 7506-E-V
Ethicon† (Note length is 15 mm short)
Proximate®* 100 EGIATRS60AMT OR EGIATRS60AXT PSD 10002-E-V PSD 10006-E-V
(Note length is 40 mm short)

ENDOSCOPIC Linear Staplers

Endo GIA™ Universal EGIATRS45AMT OR EGIATRS45AXT PSD 3002-U-V PSD 3606-U-V
30 mm or Endo GIA™ (Note length is 15 mm longer)
30 mm Reloads with
Tri-Staple™ Technology
Endo GIA™ Universal EGIATRS45AMT OR EGIATRS45AXT PSD 4502-U-V PSD 4506-U-V
45 mm or Endo GIA™
45 mm Reloads with
Covidien Tri-Staple™ Technology
Endo GIA™ Universal EGIATRS60AMT OR EGIATRS60AXT PSD 6002-U-V PSD 6006-U-V
60 mm or Endo GIA™
60 mm Reloads with
Tri-Staple™ Technology
Powered SGIA™ 60 N/A PSD 6002-U-V PSD 6006-U-V
(knifeless)
Echelon™* 45 EGIATRS45AMT OR EGIATRS45AXT PSD 4502-ECH-V PSD 4506-ECH-V
Echelon™* 60 EGIATRS60AMT OR EGIATRS60AXT PSD 6002-ECH-V PSD 6006-ECH-V
Ethicon ETS 45 EGIATRS45AMT OR EGIATRS45AXT PSD 4502-ETS-V PSD 4506-ETS-V
ETS 60 EGIATRS60AMT OR EGIATRS60AXT PSD 6002-ETS-V PSD 6006-ETS-V
EZ45 EGIATRS45AMT OR EGIATRS45AXT PSD 4502-E-V PSD 4506-E-V

†12 packages per box

9
 Cross Reference Charts

COOK®* MEDICAL
Biodesign®* is a non-dermis-based biologic reinforcement material that is pre-coated with a water soluble adhesive and loaded
on the stapler cartridge with a foam applicator. It increases tissue thickness by 0.5 mm.

Biodesign®* Staple Line Reinforcement

Fits Stapler
OPEN Line Staplers
G54251 EGIATRS60AMT OR EGIATRS60AXT C-SLRA-OPEN-GIA60 GIA™ 60
(note length will be 20 mm shorter for the
80 mm stapler)
Covidien
G54252 EGIATRS60AMT OR EGIATRS60AXT C-SLRA-OPEN-GIA80 GIA™ 80
(note length will be 20 mm shorter for the
80 mm stapler)
G50866 EGIATRS60AMT OR EGIATRS60AXT C-SLRA-TCT-TLC55 Proximate®* TCT 55/TLC 55
(note length will be 5 mm longer)
Ethicon
G50865 EGIATRS60AMT OR EGIATRS60AXT C-SLRA-TCT-TLC75 Proximate®* TCT 75/TLC 75
(note length will be 15 mm shorter)

ENDOSCOPIC Linear Staplers

G50656 EGIATRS45AMT OR EGIATRS45AXT C-SLRA-GIA30 Endo GIA™ 30
(note this will be 15 mm longer)
Covidien G50868 EGIATRS60AMT OR EGIATRS60AXT C-SLRA-GIA45 Endo GIA™ 45
(note this will be 15 mm longer)
G50867 EGIATRS60AMT OR EGIATRS60AXT C-SLRA-GIA60 Endo GIA™ 60
G50870 EGIATRS45AMT OR EGIATRS45AXT C-SLRA-EZ45 EZ45
G51746 EGIATRS45AMT OR EGIATRS45AXT C-SLRA-ECH45 Echelon™* 45
Ethicon G23662 EGIATRS45AMT OR EGIATRS45AXT C-SLRA-TN45 Echelon™* 45
G50871 EGIATRS60AMT OR EGIATRS60AXT C-SLRA-ECH60 Echelon™* 60
G24827 EGIATRS60AMT OR EGIATRS60AXT C-SLRA-TN60 Echelon™* 60

Note: All staple line reinforcement strips sold in boxes of 5.

G23662 is also available for the Endo GIA™ 45 stapler

(recommend EGIATRS45AMT OR EGIATRS45AXT)

G24827 is also available for the Endo GIA™ 60 stapler

(recommended EGIATRS60AMT OR EGIATRS60AXT)

10
 Material Properties

Tensile
Basis Initial Tensile Material
Thickness Strength
Reinforcement Product Polymer Weight Strength Degradation
(mm) Retention
(g/m2) (N) (weeks)
(days)

Reinforced Reload with Polyglycolic acid

55.4† <0.4† 18.4¶ 14¶ 15∑
Tri-Staple™ Technology (PGA)

GUNZE Neoveil™* Polyglycolic acid

79.8‡ <0.5|| 23.4†† 21†† 15||
Tube Type (PGA)

Polyglycolic acid:
GORE®* Trimethylene
91.4‡ < 0.5§ 8.1¶ 14¶ 24-28∂
SEAMGUARD®* carbonate
(PGA:TMC)

Scanning electron microscopy (SEM) images (below)

show that the Reinforced Reload material is
comprised of small uniformly packed fibers, resulting
in a strong, porous, and compressible material

Reinforced Reload material morphology (250x), with staple leg penetration (150x), and a cross section (250x)¥

SEAMGUARD®* material morphology (250x), with staple leg penetration (150x), and a cross section (250x)¥

∑ Reinforced Reload Benchtop Testing, In-Vitro Mass Loss, Engineering Report: 2183-060-0.
† Reinforced Reload Benchtop Testing, Sterile vs. Non-Sterile Neoveil, Engineering Report:
2183-073-1.
‡ Reinforced Reload Benchtop Testing, Competitive Buttress Characterization, Engineering
Report: 2183-081-0.
§ www.goremedical.com/resources/dam/assets/AJ0203ML5.EBSG.IFU.EN.pdf.
|| Neoveil™* IFU: NEOVEIL(Absorbable Polyglycolic acid felt): Tube type.
¶ 2183-061-0QIK00049 Final GLP Report to Ship (Strength retention defined as the
timepoint where specimens become untestable).
∂ Katz AR, Mukherjee DP, Kaganov AL, Gordon S. A new synthetic monofilament
absorbable suture made from polytrimethylene carbonate. Surgery, Gynecology &
Obstetrics 1985;161(3):213-222.
†† Gunze Engineering Report: NV tube type strength loss 20130920.
¥ Reinforced Reload Benchtop Testing, SEM Images, Engineering Report 2183-074-1.
11
 Competitive Comparison

Reinforced
Reload with GUNZE Baxter GORE®* COOK®*
Tri-Staple™ Neoveil™* Tubes Peri-Strips®* SEAMGUARD®* Biodesign®*
Technology

Preloaded ü

Synthetic ü ü ü

Absorbable ü ü ü

Absorbent ü ü ü ü ü

Available in
45 mm & 60 mm ü ü ü ü ü

Added thickness
<0.4 mm ü

No extra
“wings” ü ü ü

No strings ü ü ü

No gel required ü ü ü ü

12
 Pre-Clinical Testing

In vivo Strength Loss Strength Degradation In-vivo

95% CI for the mean
Reinforced Reload with Tri-
20
Staple™ technology had 18.4
significantly greater tensile
strength than W. L. Gore®*
SEAMGUARD®* initially and at
seven days in-vivo 15
(2-sample t-test: p-values = Reinforced Reload

Tensile Failure Force (N)

with Tri-Staple™ Technology
0.000 and 0.007). There was
Tri-Staple™ Technology
no distinguishable difference with SEAMGUARD®*
in strength at fourteen days 10
(2-sample t-test: p-value =
8.1
0.793).1
6.0

2.3
1.0
0.8

0 0 7 14

Timepoint (days)

In vitro Mass Loss Time to Material Absorbtion (Mass Loss)

24-28

Neoveil™* Tubes from GUNZE, 25

and the Reinforced Reload
with Tri-Staple™ technology
were essentially resorbed in 20
Time to <20% Original Mass (weeks)

15 weeks2,3, while W. L. Gore®*

SEAMGUARD®* takes essentially
24-28 weeks4. 15 15
15

10

0
GUNZE Neoveil™* Tube Preloaded PGA on GORE®* SEAGUARD®*
(PGA) Reinforced Reload

1. Reinforced Reload Pre-Clinical Testing, A GLP Evaluation of the Strength Loss of PGA Buttress Material in a Rabbit Model, Report # 2183-061-0.
2. Reinforced Reload Pre-Clinical Testing, In-Vitro Mass Loss; Report: In vitro Mass Loss; 1/23/14 (2183-060-0).
3. http://www.gunze.co.jp/e/medical/product/pdf/neoveil_tube_catalog.pdf
4. http://www.goremedical.com/resources/dam/assets/AJ0203ML5.EBSG.IFU.EN.pdf

13
 Pre-Clinical Testing

Acute Hemostasis
Reinforced Reload AMT was fired across canine small bowel and compared against Tri-Staple™
technology AMT with SEAMGUARD®* and Tri-Staple™ technology AMT without buttress.
Reinforced Reload exhibited a completely bloodless staple line 100% of the time when
firing across canine small bowel, which was superior compared to non-buttressed reloads
(2-Proportion Test, Fisher’s exact test, p-value = 0.037, n=12)1. All reloads provided adequate
hemostasis; however, the additional compression provided by the Reinforced Reload with
Tri‑Staple™ technology eliminated small areas of focal bleeding compared to equivalent,
non-buttressed staple lines.

Percentage of Dry Staple Lines In Acute Hemostasis Testing

p-value=0.0371
100% 100%
100

80

58%
Percentage (%)

60

40

20

0 Tri-Staple™ Technology Reinforced Reload Tri-Staple™ Technology

without Buttress with Tri-Staple™ with SEAMGUARD®*
Technology

1. R
 einforced Reload Bench Top Testing, Acute Hemostasis in Canine Small Bowel, 11/26/13, Report # 2183-075
(Published Model, applicable to EGIA60AMT reload).

14
 Bench Top Testing

Acute Pneumostasis
Reinforced Reload AMT and Tri-Staple™ technology AMT without buttress were fired in
freshly excised canine lungs in a match paired scheme. The lungs were submerged and
positive pressure was applied using a ventilator at 15, 20, 30 and 40 cm H 0. No air leaks 2

were observed in any of the Reinforced Reload staple lines while the Tri-Staple™ technology
without buttress staple lines began to leak significantly at 30-40 cm H 0. Reinforced Reloads 2

with Tri-Staple™ technology provided superior pneumostasis at 40 cm H 0 (2-Proportion Test, 2

Fisher’s exact, p-value = 0.001)1.

100
of Pneumostatic Staple Lines (%)

80

60
Reinforced Reload with
Tri-Staple™ Technology
Tri-Staple™ Technology
without Buttress
40

20

0
15 20 30 40

Pressure (cm H2O)

1. R
 einforced Reload Bench Top Testing, Acute Pneumostasis in Canine Lung, 11/20/13, Report # 2183-075 (Published Model, Contini E,
Godek ML, Whiffen JM, Bronson DG. Ex Vivo Pneumostasis Evaluation of a Variable-Height Staple Design. Innovations:Technology and
Techniques in Cardiothoracic and Vascular Surgery 2013;8:284-8 10.1097/IMI.0b013e3182a6912a.)
15
 Pre-Clinical Testing

Acute Leak Test

Reinforced Reload was fired across canine bowel in a match paired study to compare the acute
leak pressure against Tri-Staple™ technology with SEAMGUARD®* and Tri-Staple™ technology
without buttress. Reinforced Reload had a superior leak pressure compared to Tri-Staple™
technology without buttress and there was no significant difference compared to Tri-Staple™
technology with SEAMGUARD®* (ANOVA with Tukey Family Grouping, p-value = 0.004)1.

Gastrointestinal Leak Pressure

95% CI for the Mean

250
12/12 12/12

200
Leak Pressure (mm Hg)

150

100

50

0
Tri-Staple™ Technolgy Tri-Staple™ Technology Reinforced Reload
without Buttress with SEAMGUARD®* with Tri-Staple™
Technology

1. Reinforced Reload Bench Top Testing, In Vivo Leak Testing in Canine Bowel, 12/2013, Report # 2183-075-In Vivo Competitive Testing.
16
 Bench Top Testing

Bench Top Comparison of Material Abrasion

A novel benchtop method was developed to compare the relative abrasiveness
between Reinforced Reload AMT compared to Tri-Staple™ technology AMT
with SEAMGUARD®*, and Tri-Staple™ technology AMT with Neoveil™* Tube Type
reinforcement. Test specimens were made to mimic a lung wedge resection by firing
crossing staple lines from each group into a synthetic media to form a 90º wedge.
Samples from each group (n=9) were dragged across a soft gel using an actuator and
the resulting defects were evaluated using 3-dimensional laser scanner. The resulting
defects from the Reinforced Reload group were on average smaller in volume than
Tri-Staple™ technology with SEAMGUARD®* or Tri-Staple™ technology with Neoveil™*
Tube Type.1-3

Individual Value Plot of Defect Volume (mm3)

95% CI for the Mean

300
Defect Volume (mm3)

200

100

0
Reinforced Reload SEAMGUARD®* Neoveil™* Tubes
with Tri-Staple™
Technology

1. Engineering Report 2183-033-0 A Comparative Analysis of Staple Line Reinforcement in Benchtop and Pre-Clinical Studies
2. Benchtop Model for Comparison of Abrasiveness between Surgical Devices. Timothy Ebner, David Jermine, Angela Throm, Dwight
Bronson. Society for Biomaterials 2014, Oral Abstract Presentation.
3. A Benchtop Model for Comparison of Implant Abrasiveness. Tim D. Ebner, Angela Throm, David Jermine, Elizabeth Contini, Dwight
Bronson. European Society for Surgical Research 2014, Oral Abstract Presentation.
17
 Pre-Clinical Testing

Chronic Thoracic Model

A canine model was utilized to evaluate the effect of staple lines with and without staple
line reinforcement materials on surrounding tissues in the thoracic cavity. A total of ten
clinically relevant sites were created in each subject (see Figure 1 below). Subjects were
evaluated at post-operative Day 7. A scoring method was established for assessing abrasion
(range of scores: 0 (no abrasions) - 5 (severe abrasions)). Reinforced Reload with Tri-Staple™
technology (n = 50) was compared with SEAMGUARD®* used in conjunction with
Tri-Staple™ technology (n = 50) and Tri-Staple™ technology staple lines without buttress
material (n = 20); all staplers utilized were the same size.

Results: Median Abrasion Scoring

There were no intraoperative air Cranial 2 4
leaks from any staple lines, nor were 5

any post-operative complications 1

3
observed. Performance for
Reinforced Reload with Tri-Staple™
Left Lateral view
technology and SEAMGUARD®* Cranial

used in conjunction with Tri-Staple™

5 2
technology were determined to be 4
comparable for metrics assessed. The 1
3
median abrasion score for Reinforced
Reload with Tri-Staple™ technology Figure 1 1.
Figure Right lateral view
was lower than that observed for
SEAMGUARD®* used in conjunction
with Tri-Staple™ technology (n = 50 for both, p = 0.0016).1-2

Reinforcement Product Median Abrasion Score

Reinforced Reload with Tri-Staple technology (n = 50)
™
0 (no abrasions)
SEAMGUARD®* used in conjunction with Tri-Staple™ 1 (Roughening of the surface of the pleura
technology (n = 50) or presence of sub pleural petechiae)
Tri-Staple™ technology without buttress (n =20) 0 (no abrasions)

Figure 2. Image (left) shows Reinforced Reload with

Tri-Staple™ technology staple lines at postoperative
Day 7. Areas of the staple line have been circled; the
circled area to the left shows a “tab” that was cut to
a standardized length and intentionally left in place for
the study. The circled area to the right shows a staple
line that is well encapsulated by tissue. Between the
two circles lies an area where the staple lines were
deliberately crossed.

1. Reinforced Reload Pre-Clinical Testing, Abrasion Assessment of Staple line Reinforcement Materials in the Thorax of a
Canine, 4/4/13, Report #2183-027.
2. Soltz et al, Abrasion Assessment of Staple Line Reinforcement Materials in the Thorax of a Canine (2014). Society of
American Gastrointestinal and Endoscopic Surgeons.
18
 Pre-Clinical Testing

Chronic Abdominal Model

A canine model was utilized to evaluate the effect of staple lines with and without staple line
reinforcement materials on surrounding tissues in the abdominal cavity, and to assess the extent
and maturity of adhesions present, if any. A total of eight clinically relevant sites were created in the
stomach and duodenum of each subject (see Figure 1 below). Subjects were evaluated at postoperative
Day 14. Scoring methods were established for assessing abrasion (range of scores: 0 (no abrasions)
- 5 (severe abrasions)) and adhesions (range of scores 0 (no adhesions) – 3 (multi focal adhesions)).
Reinforced Reload with
Tri‑Staple™ technology (n 1. Line of the gastrectomy (towards the cardia
as shown in Fig 1)
= 40) was compared with 1
2. Line of the gastrectomy (towards pylorus as
SEAMGUARD used in
®* 2
shown in Fig 1)
conjunction with Tri-Staple™ 4
3
(Approximately 1m length) 3. Gastro-jejunostomy enterotomy closure
technology (n = 40) and Tri- 5 7 4. Duodenal transection (oral)
Staple technology staple lines
™ 8 5. Duodenal transection (aboral)
6. Oral jejunal transection
without buttress material (n = 6
7. Aboral jejunal transection
16); all staplers utilized were the 8. Jeju-jejunostomy enterotomy closure
same size. Figure 1.

Results
No abrasions were observed in any of the subjects at post-mortem evaluation. Omental covering
was observed on most of the anastomotic staple lines (Figure 2, below). The adhesion extent
for Reinforced Reload with Tri-Staple™ technology and SEAMGUARD®* used in conjunction
with Tri-Staple™ technology was found to be no different from non-buttressed staple lines (p =
1.000). There were no intraoperative air leaks from any staple lines, nor were any post-operative
complications observed.1-2

Reinforcement Product Median Abrasion Score Median Adhesions

Reinforced Reload with Tri-Staple ™
0 (no abrasions) 1 (adhesion involved one organ)
technology (n = 40)
SEAMGUARD®* used in conjunction
0 1
with Tri-Staple™ technology (n = 40)
Tri-Staple™ technology without
0 1
buttress (n =16)

Figure 2. Image (left) shows representative results for

gross observations upon necropsy (postoperative Day
14). Areas which were covered by the omentum have
been indicated with white circles.

1. Reinforced Reload Pre-Clinical Testing, Development and Utilization of a Canine Model to Assess Staple Line Reinforcement Materials in the
Abdomen, 5/9/13, Report #2183-034.
2. Soltz et al, Abrasion Development and Utilization of a Canine Model to Assess Staple Line Reinforcement Materials in the Abdomen (2014). 19
Society of American Gastrointestinal and Endoscopic Surgeons.
 Histopathology

Results: Pre-Clinical Thoracic Model Histopathology

(Lung Parenchyma, Post-Operative Day 71)

H&E, 100X
Figure 1. Photomicrograph (100 times magnification) of tissue stained with hematoxylin and
eosin (H & E). PGA material (light blue structures), N = neovascularization, I = mild inflammation.

Results
• PGA (blue oval structures) was present (as expected) at post-operative Day 7 in canine
lung tissue

• Moderate to marked neovascularization (“N”) and mild to moderate inflammation (“I”)

were observed throughout the area containing PGA (buttress) material, indicative of the
healing response

• Additionally, mild tissue ingrowth was observed at this time point, indicative of
remodeling of the wound site

1. Reinforced Reload Pre-Clinical Testing, Abrasion Assessment of Staple Line Reinforcement Materials in the Thorax of Canine, 4/4/13,
Report #2183-027.
2. Reinforced Reload Preclinical Testing. Histology Summary for Thoracic Chronic Data. Engineering Report 2183-089-0 with Appendix 1.

20
 Histopathology

Results: Chronic Abdominal Model Histopathology

(Stomach and Duodenum, Post-Operative Day 141)

H&E, 100X

H&E, 100X
Figure 1. Photomicrograph (100 times magnification) of tissue stained with Figure 2. Photomicrograph (100 times magnification) of tissue stained with hematoxy-
hematoxylin and eosin (H & E). PGA material (light blue structures), yellow arrows = lin and eosin (H & E). PGA material (light blue structures), yellow arrows = neovascular-
neovascularization, I = mild inflammation, TI = tissue ingrowth. ization, I = mild inflammation TI = tissue ingrowth.

Results: Median Abrasion Scoring

• PGA (blue oval structures) was present (as expected) at post-operative Day 14 in canine
gastrointestinal tissue

• Mild neovascularization (red areas) and mild to moderate inflammation (“I”) were
observed throughout the area containing PGA (buttress) material, indicative of the
healing response

• Additionally, mild tissue ingrowth (TI) was observed at this time point, indicative of
remodeling of the wound site

1. R
 einforced Reload Pre-Clinical Testing, Development and Utilization of a Canine Model to Assess Staple Line Reinforcement Materials
in the Abdomen, 5/9/13, Report #2183-034.
2. R
 einforced Reload Preclinical Testing, Histology Summary for Abdominal Chronic Data, Engineering Report 2183-090-0 with Appendix
1 and 2.

21
 Post Market Study

Economic Evidence Shows Benefits of

Preloaded Buttress Material versus
a Manually Loaded Buttress Material
Covidien conducted a post market qualitative survey with 250 U.S. surgeons and
nurses who are familiar with buttress products. They were asked to compare their
experience with a preloaded buttress on an endo stapling device versus manually
loading a buttress on an endo stapling device.

The results indicate:

• Buttress waste is prevalent, with 2-in-3 HCPs reporting at least some (under ~20% of
surgeries) buttress waste in an average month.

• Each time a buttress is wasted, 7 to 10 minutes of time is lost, depending on the

type of buttress waste (e.g. material wrinkled and moved; material wasn't loaded
correctly or the strings were not removed as per the IFU).

• 2-in-3 health care professionals report roughly 10% of buttress material is wasted in
an average month.

Summary: In indicated procedures where buttress material is needed, Reinforced

Reloads with Tri-Staple™ technology may provide a hospital with increased OR
efficiency (via improved time savings and reduced product spoilage) when compared
to buttress material that must be separately loaded onto a stapler cartridge1.

1. "Survey of tissue reinforcement users to determine waste and time loss attributed to separately loaded buttress materials in the OR."
Online U.S. national sample of 125 surgeons and 125 OR nurses. Covidien-sponsored study by ORC International, 11/9/11.
22
510(k) Clearance

23
 510(k) Clearance

24
Box size: 15.5 x 5.25
Overall Size: 8.5 x 11
Folds to: 4.25 x 3.667
Instructions For Use

7. Securing the target tissue prior to and during firing with an atraumatic grasper may reduce tissue slipping during the firing stroke. When closing the Endo
GIA™ reinforced reload with Tri-Staple™ Technology, the tissue may extrude distally and laterally as you clamp and/or fire when in thick tissue and/or crossing
intersecting staple lines. To minimize this, the use of an atraumatic grasper is recommended to place and secure the tissue within the jaws. As the instrument is

Endo GIA™ fired, use gentle proximal traction with the grasper placed next to the reload until the deployed staples provide acceptable support.
8. As with any temporary implanted prosthetic, the material can elicit a slight acute inflammatory response in tissues, and its implantation may result in
inflammation or partial extrusion of material with late absorption or mechanical irritation and may result in a pH decrease by accumulation of dissolved
Reinforced Reload with Tri-Staple™ Technology unmetabolized degradents and inflammation caused from the pH decrease.
9. As with any foreign body, prolonged contact of this or any other reinforcement material with salt solutions, such as those found in the urinary or biliary tracts,
1073714 may result in calculus formation.
10. To avoid damage or contamination, always use clean gloves and ensure care is taken when handling the Endo GIA™ reinforced reload with Tri-Staple™
Technology, so as not to damage the staple line reinforcement material.
A 11. Dispose of used instruments and used reloads in accordance with the end-user’s medical and biological waste disposal requirements.
12. Store at room temperature. Avoid prolonged exposure to elevated temperatures.
B 13. If the desiccant packaged in the foil pouch has been compromised, discard the Endo GIA™ reinforced reload with Tri-Staple™ Technology.
14. Before attempting to load a previously loaded but unused reload, reattach the shipping wedge ensuring that the raised post on the shipping wedge is
C D properly seated in the anvil of the reload. Then follow the loading procedure as described in the instructions for use for the GIA™ universal stapler, Endo GIA™
universal stapler, Endo GIA™ Ultra universal stapler, and iDrive™ Ultra powered handle with Endo GIA™ adapter.
15. The titanium staples in this device are nonferromagnetic and may undergo MRI and/or NMR procedures at forces of 3.0 Tesla or less after implantation.
1 SCHEMATIC VIEW
E A) SINGLE USE REINFORCED RELOAD WITH Tri-Staple™ TECHNOLOGY (45 or 60mm lengths)
B) ANVIL
C) STAPLE CARTRIDGE
BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY. D) SHIPPING WEDGE
IMPORTANT! E) STAPLE LINE REINFORCEMENT
This booklet is designed to assist in using this product. It is not a reference to surgical techniques. NOTE: Dipping the reload in sterile saline prior to positioning the reload at the target tissue may help flatten the material on the
This device was designed, tested and manufactured for single patient use only. Reuse or reprocessing of this device may lead to its failure and subsequent patient cartridge.
injury. Reprocessing and/or resterilization of this device may create the risk of contamination and patient infection. Do not reuse, reprocess or resterilize this
device.
DESCRIPTION
The Endo GIA™ reinforced reload with Tri-Staple™ Technology is pre-attached with a polyglycolic acid (PGA) staple line reinforcement. The reload includes a
non-woven absorbable mesh prepared of polyglycolic acid and dyed with D&C Green No. 6 on both the anvil and cartridge. This decreases the thickness of tissue
that can be compressed by 0.3 mm. The PGA reinforcement material degrades via a combination of hydrolytic and enzymatic pathways. The PGA staple line
reinforcement material has been found to be biocompatible and non-antigenic, with a history of use as bio-absorbable sutures and other implantable devices.
The strength profile for the reinforcement material shows mechanical strength through the critical wound healing period of 10 to 14 days post-surgery. The
residual measurable strength for the reinforcement material is 32% at 7 days and 2% at 14 days.
The PGA staple line reinforcement material is secured to the anvil and cartridge of the Endo GIA™ reinforced reload with Tri-Staple™ Technology and a Maxon™
synthetic absorbable anchoring suture. During firing, the Maxon™ anchoring sutures release the PGA reinforcement material from the reload to allow its
placement of the PGA reinforcement material on the tissue. The Maxon™ suture remains with the reload and is discarded after use.
The Endo GIA™ reinforced reload with Tri-Staple™ Technology places a triple-staggered row of titanium staples and two layers of absorbable reinforcement
material on either side of the cut line. As the staples are deployed, the tissue and staple line reinforcement material are simultaneously divided. The size of the
staples is determined by the selection of the reload. The Endo GIA™ reinforced reload with Tri-Staple™ Technology is available in articulating 45 mm and 60 mm
lengths in purple and black configurations. The purple reload has height progressive rows of 3.0 mm, 3.5 mm and 4.0 mm titanium staples on either side of the
cut line. The black reload has height progressive rows of 4.0 mm, 4.5 mm and 5.0 mm titanium staples on either side of the cut line.
The Endo GIA™ reinforced reload with Tri-Staple™ Technology is provided STERILE for single use only. The Endo GIA™ reinforced reload with Tri-Staple™
Technology is sterilized by ethylene oxide gas. The product should be stored at room temperature.
The Endo GIA™ reinforced reload with Tri-Staple™ Technology can be used with the GIA™ universal staplers, Endo GIA™ universal staplers, Endo GIA™ Ultra
universal staplers and the iDrive™ Ultra powered handle with Endo GIA™ adapter.
Refer to the instructions for use for the GIA™ universal stapler, Endo GIA™ universal stapler, Endo GIA™ Ultra universal stapler and the iDrive™ Ultra powered
handle with Endo GIA™ adapter for specific indications, contraindications, warnings, precautions, and operating instructions.
INDICATIONS
Endo GIA™ reinforced reload with Tri-Staple™ Technology preloaded with polyglycolic acid staple line reinforcement has applications in abdominal, gynecologic,
pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. They may be used for transection and resection of liver substance,
hepatic vasculature and biliary structures, and for transection and resection of pancreas.
CONTRAINDICATIONS
Do not use for the patch reconstruction of cardiovascular defects such as cardiac, great vessel and peripheral vascular arteries or vein.
To allow for the reinforcement material total thickness of 0.300 mm on a reload, the tissue thickness ranges are as follows:
For the purple reload: Do not use on tissue that does not easily compress to 1.2 mm-1.95 mm.
For the black reload: Do not use on tissue that does not easily compress to 1.95 mm-2.7 mm.
WARNINGS
1. Use of this product in applications other than those indicated has the potential for serious complications, such as inadequate reinforcement strength, staple
pullout, infection, abrasion, migration and erosion.
2. When positioning the stapler on the application site, ensure that no obstructions, such as clips, are incorporated into the instrument jaws. Firing over an
obstruction may result in incomplete cutting action and/or improperly formed staples.
3. Do not use the Endo GIA™ reinforced reload with Tri-Staple™ Technology in conjunction with other reinforcement materials. This may cause staple malfunction
and poor hemostasis resulting in leaks and tissue ischemia.
4. In the event there is extra material with or without staples protruding beyond the tissue and cut edge, remove this material with scissors.
5. Do not attempt to remove the yellow shipping wedge until the Endo GIA™ reinforced reload with Tri-Staple™ Technology is loaded into the instrument. Failure
to do so may result in loading unit jaws not opening after clamping and firing on tissue. The shipping wedge should be retained until the completion of the case.
Please refer to the applicable Endo GIA™ universal stapler and Endo GIA™ Ultra universal stapler instructions for use for detailed loading instructions.
6. Do not clamp instrument prior to removing shipping wedge.
ADVERSE REACTIONS
Possible adverse reactions may include, but are not limited to: infection, inflammation, adhesions and hematoma.
PRECAUTIONS
1. If the Endo GIA™ reinforced reload with Tri-Staple™ Technology is inserted percutaneously, ensure the incision is wide enough to accommodate the instrument
so that excessive force is not placed on the jaws of the instrument.
2. When using the Endo GIA™ Ultra universal stapler to grasp or manipulate tissue multiple times, the staple line reinforcement material secured on the anvil
and cartridge may move and/or dislodge.
3. In the event that the reinforcement material shifts upon clamping, unclamp the stapler and reposition on tissue.
4. When using the Endo GIA™ reinforced reload with Tri-Staple™ Technology with the iDrive™ Ultra powered handle and Endo GIA™ adapter in challenging
applications, the firing sequence may stop prematurely. The propensity to stop prematurely may increase if the reload is in the articulated position. If the firing
does stop prematurely, release the blue CLOSE/FIRE button, assess the tissue for obstructions, and wait approximately 15 – 30 seconds to allow the tissue to
compress. After waiting 15-30 seconds, press the CLOSE/FIRE button to continue the firing stroke. The knife blade will stop automatically at the distal end of the
reload when the firing stroke is complete. A complete firing stroke can be confirmed by visual indicators on the iDrive™ Ultra powered handle and the reload. In
the event that the firing cannot be completed, the knife blade can be retracted and the jaws opened by pressing the silver OPEN button. Refer to Precaution #5 Do not use if Caution, consult
for instructions to release the distal Maxon™ anchoring sutures in the event of an incomplete firing. Do not package is opened accompanying
5. In the event of an incomplete firing of the Endo GIA™ reinforced reload with Tri-Staple™ Technology, the distal Maxon™ anchoring sutures used to secure Single use resterilize or damaged documents
the staple line reinforcement material to the anvil and cartridge may not be released, the inability to release the distal anchor suture will prevent the jaws from
opening fully when the device is unclamped. The remaining intact staple line reinforcement material on the reload will need to be removed from the device by © 2013 Covidien.
gentle traction and/or by cutting the anchor suture with scissors. Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA.
6. After complete firing, inspect the staple line for hemostasis; minor bleeding may be controlled by electrocautery or manual sutures. Additionally, small Covidien Ireland Limited, IDA Business & Technology Park, Tullamore.
pieces of the Maxon™ sutures that secured the Endo GIA™ reinforced reload with Tri-Staple™ Technology with the PGA staple line reinforcement material may be
www.covidien.com
dislodged and observed in the surgical field.
COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of Covidien AG. Other brands are
trademarks of a Covidien company, ™* brands are trademarks of their respective owner.
2014/02 - 3

25
 COVIDIEN, COVIDIEN with logo, COVIDIEN logo and positive results for life are U.S.
and internationally registered trademarks of Covidien AG. ™* and ®*are Trademarks
of its respective owner. Other brands are trademarks of a Covidien company.
©2014 Covidien. 7.14 P140008-1

555 Long Wharf Drive Phone: 1-800-722-8772 www.covidien.com

New Haven, CT Fax: 1-888-636-1002
06511
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