Technical Guide

Below and Beyond in LAR.

Endo GIA™ Radial Reload with Tri-Staple™ Technology

Covidien is setting new standards for access, maneuverability and staple line security in LAR procedures with this innovative new design. The Endo GIA™ Radial Reload will deliver optimal performance, even in challenging cases.

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

technology allows surgeons uncompromised access and

visibility in the deep pelvis. Surgeons can operate with

confidence across a broader range of tissue thickness

and lower in the pelvis compared to Ethicon Contour®* 1.

1

Key Features

• Tri-StapleTM technology

• Progressive staple heights, unique tapered cartridge face

• Narrow profile

• Operates in both Coronal and Sagittal planes

• 360 degree rotation

• Staples and transects tissue

• Unique tissue retention feature

•Compatible with all Endo GIA™ Universal, Endo GIA™ Ultra Universal, and iDrive™ Ultra powered handles‡

Performance Beyond Expectations

•Lower access and visibility in the pelvis compared to Contour®* 1, potential for greater distal margins

•Easier placement in the deep pelvis compared to Contour®*2

•Will clamp and transect the rectum - when tissue does not exceed the length of the reload

•Designed to accommodate a wide range of tissue thicknesses, simplifying the cartridge selection process and reducing inventory burden

2

Access without compromise.

The new Radial Reload with Tri-Staple™ technology delivers unprecedented access and ease of use. It offers better visibility when compared to Contour®*1 and the potential for better distal margins.

With its curved architecture and the benefits of Tri-Staple™ technology, the Radial Reload delivers optimal performance even in challenging cases.

Enhanced access and visibility facilitate better distal margins.

The narrow profile and unique geometry improves visualization in the pelvis when compared to Contour®*1. In addition, the cartridge’s curvature places its jaws lateral to the handle and shaft.

Surgeon feedback has confirmed that these features provide improved visualization of the rectum during transection when compared to Contour®*1

Innovative tissue retention feature.

The Radial Reload incorporates a unique spring loaded tissue retainer affixed to the distal tip of the cartridge. This feature is designed to assist in guiding the device into place without entrapment of excessive tissue.

In the event that the Radial Reload is used on tissue exceeding the length of the reload, the tissue retention feature will safely retract to allow the excess tissue to extrude forward.

All the benefits of Tri-Staple™ technology.

The Radial Reload incorporates Tri-Staple™ technology and all the benefits of its unique design. This includes improved leak pressure3, added staple line security4 and the ability to manage tissue variability.

The Endo GIA™ Radial Reload with Tri-Staple™ technology will be available in Purple (3.0, 3.5, 4.0 mm).

Extra-Thin Range Thin Range Medium Range Thick Range Extra-Thick Range

RELOAD SELECTION CHART

Vascular

Medium/Thick

Ethicon Contour®* Curved Cutter and Reloads

New Endo GIA™ Radial Reload with Tri-Staple

Simplifies cartridge selection process

™ Technology

Regular Thick

Endo GIA™ Radial Reload with Tri-Staple™ Technology

Reorder Code Description Cartridge Color Staple Size (inner to outer row)

EGIARADMT Endo GIA™ Radial Reload with Tri-Staple™ Technology Purple 3.0 mm, 3.5 mm, 4.0 mm

Ordering Information

Enhanced Performance For Low Anterior Resection

3

Radial Reload vs. Contour®* Testing Highlights

Visualization

In a cadaver study, surgeons found the Radial Reload allowed better visualization than the Contour®*1

•Surgeons found the Contour®* impeded visibility over the Radial Reload (p=0.000) in the coronal plane

•Visualization score increased by 25% in the sagittal plane (p=0.0003) over the Contour®*

Depth Measurement

In a cadaver study, surgeons found the Radial Reload allowed lower access in the pelvis compared to Contour®* in both the coronal and sagittal planes1. Distance was measured from the pelvic floor to device.

• In the sagittal plane, the Radial Reload was able to get an average of 1.8 cm lower (p=0.000) than Contour®*

• In the coronal plane, the Radial Reload was able to get an average of 0.6 cm lower (p=0.000) than Contour®*

0

1

2

3

4

5

6

Contour Sagittal n=48Contour Coronal n=48Radial Sagittal n=47Radial Coronal n=47

1.4 1.42.0

3.2

Average Depth from Pelvic Floor in Cadaver

Dis

tanc

e fr

om P

elvi

c Fl

oor

(cm

)

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

Contour Sagittal n=48Radial Sagittal n=48Contour Coronal n=48Radial Coronal n=48

Average Visualization Ratings in Cadaver

Visu

aliz

atio

n Ra

ting

(Sca

le 1

-3)

Coronal Plane Sagittal Plane

4

Radial Reload in Cadaver Radial Reload in Cadaver

Radial Reload vs. Contour®* Testing Highlights

Staple Line Strength

In a strength test, staple lines were fired into Tyvek® media and pulled apart until failure. The Radial Reload showed superior staple line strength compared to Contour®*4.

• 200% stronger staple line compared to Contour®* Blue (p=0.000)

• 80% stronger staple line compared to Contour®* Green (p=0.000)

0

5

10

15

20

25

Radial Reload PurpleContour GreenContour Blue

6.906 11.767 21.086 17.818

Tyvek® Pull: Staple Line Strength

Stap

le L

ine

Stre

ngth

(Ibf

)® ®

5

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

5.0

Contour n=16Radial Reload n=33

2.640 2.064

In-Vivo Leak Pressure

Aver

age

In-V

ivo

Leak

Pre

ssur

e (P

SI)

®

In-Vivo Leak Comparison

Radial Reload showed comparable leak resistance to Ethicon Contour®5.

The test consisted of fluorescently-dyed water being injected into sections of bowel. The water was infused until failure, and corresponding pressures were recorded.

In-Vitro Leak Comparison

Test results conclusively showed that the Radial Reload improves the intra-luminal leak pressure by 30% compared to the Contour®* Green (p=0.016)3.

Reloads were fired across a synthetic media tube creating a pouch. Flourescently dyed water was infused into the pouch until a leak was detected and the corresponding pressure was recorded.

0.0

0.5

1.0

1.5

2.0

2.5

3.0

Blue Contour n=4Green Contour n=12Radial Reload n=12

1.960 1.508 1.855

In-Vitro Leak Pressure

Leak

Pre

ssur

e (P

SI)

® ®

6

Radial Reload vs. Contour®* Testing Highlights

-0.02

0

0.02

0.04

0.06

0.08

0.1

0.12

0.14

0.16

Contour Green n=13Contour Blue n=3Radial Reload n=16 ® ®

Amount Blood Loss

Am

ount

Blo

od L

oss

(g)

Acute Free Bleeding

The amount of blood loss at the cut line was statistically less with the Radial Reload when compared to Contour®* Green (p=0.043)6.

After transecting the bowel with comparative staplers, blood loss was collected and weighed.

7

Expanded Test Highlights

Acute Pneumostasis

The Radial Reload showed statistically equivalent acute air leak compared to Tri-Staple™ Purple (AMT) 60s7.

Pneumostasis tests were performed in an ex-vivo model. Control and test staple lines were fired on contralateral lobes of the lung, which were then insufflated to 15, 20, 30 and 40 cm H2O and observed for leaks.

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

40 cm H2030 cm H20

Acute Pneumostasis Radial Reload vs. Tri-Staple Purple (AMT) shown with 95% confidence intervals based on sample size

Perc

enta

ge o

f Sam

ples

tha

t Le

aked

PressureThickness 0.040 - 0.110”

™

8

Competitive Analysis: Dimensions

Dimensions

Radial Reload Contour®*

Total Length (mm) 535 406

Functional Access Length (mm) 320 216

Jaw Opening (mm) 16.3 19

Head Width (mm) 81 64

Linear Staple Line from first staple to end of cut line (mm) 50 38

Full Curved Staple Line (mm) 60 48

Testing Highlights (Mean Results)

Radial Reload Contour®* Green

Contour®* Blue

Access (cm from pelvic floor)1 1.4 (coronal & sagittal) 2.0 (coronal) SS or 3.2 (sagittal) SS

Tyvek® Pull Strength (lbs)4 21.1 11.8 SS 6.9 SS

In-Vitro Leak Pressure (PSI)3 2.0 1.5 SS 1.9

In-Vivo Leak Pressure (PSI)5 2.6 2.1

In-Vivo Hemostasis (g blood loss)6 0.018 0.068 SS 0.018* n=2

9

Competitive Analysis: Shaft Length

Functional Access Length = 12.6 in / 320 mm

Total Length Radial Reload = 21 in / 535 mm

Functional Access Length = 8.5 in / 216 mm

Total Length Contour®* = 16 in / 406 mm

Jaw 0.64 in / 16.3 mm

0.56 in / 14.2 mm

Jaw 0.75 in / 19 mm

10

Competitive Analysis: Width

2.76 in / 70 mm

3.2 in / 81 mm

2.0 in / 50.8 mm

2.5 in / 63.5 mm

11

Competitive Analysis: Linear Length

Tissue Envelope

Curved length from 1st staple to end of cut line

Linear length from 1st staple to end of cut line

Contour®*: 43 mm Contour®*: 38 mm

Linear length between tissue stops: 1.5 in/38.1 mm

Linear length between tissue stops: 1.6 in/40.6 mm

Total curved staple line length: 1.9 in/48.3 mm

Curve length between tissue stops: 1.8 in/45.7 mm

Curve length between tissue stops: 2.0 in/54.3 mm

Radial Reload: 55 mm

Radial Reload: 50 mm

Total curved staple line length: 2.4 in/60 mm

Radial Reload Contour®*

12

Tri-Staple™ Technology And Tissue Retention Feature

13

Tri-Staple™ Technology (Medium/Thick Cartridge)

3 rows 3.5 mm staples

Flat cartridge face

Staple heights

4.0 mm3.5 mm

3.0 mm

Stepped cartridge face

Tissue Retention Feature

Designed to maximize control, the retainer aids in the capture of tissue and prevents it from extruding during placement.

It is spring loaded and atraumatic, so if a second firing is required it will not damage tissue.

Current

Tri-Staple technology enables surgeons to use staplers in a wider variety of procedures and in a broader range of tissue thicknesses than ever before.

• Outstanding performance in variable compressed tissue thickness

•Lessstressduringclampingandcompression8

• Mayallowgreaterperfusionofbloodintothestapleline9

14

The Difference Is Intelligent† Compression

COVIDIEN, COVIDIEN with logo, and positive results for life are U.S. and/or internationally registered trademarks of Covidien AG.

All other brands are trademarks of a Covidien company. © 2012 Covidien. P110024

555 Long Wharf Drive

New Haven 06511

www.covidien.com

www.tristaple.com

Phone: 1-800-722-8772

Fax: 1-888-636-1002

1.Pelvicdepth,access,andrectaltransectioncomparativehumancadaverstudysponsoredbyCovidieninMay2010comparing the performance of the Endo GIA™ Radial Reload with Tri-Staple™ technology to the Ethicon Contour® Curved Cutter Stapler. Statistically significant results in both coronal and sagittal planes (Covidien Engineering Report No. WBS-1895; data on file).

2. Ease of Access Comparative Human Cadaver Study between Radial Reload versus the CONTOUR® Stapler. Study conducted on 12 cadavers to compare the ease of placement of the devices in the distal rectum. Study sponsored by Covidien in 2011. 

3.In-VitroBurstComparisonbetweenRadialReload,Tri-Staple60AMT,andCONTOUR®Stapler.Staplerswerefiredon non-porous foam tubing, which was then filled with fluorescently dyed water until leak and/or burst was observed from staple line, and pressure recorded. Study performed by Covidien in 2011. 

4.TyvekPullApartComparisonbetweenRadialReload,Tri-staple60AMT,andCONTOUR®Stapler. Staplerswerefired into double layers Tyvek material which was then pulled apart by Instron, the peak forces were recorded. Study performed by Covidien in 2011. 

5.In-VivoLeakTestComparisonbetweenRadialReload,Tri-staple60AMT,andCONTOUR®Stapler. Staplerswerefired into 3 canines bowel and colon, the pouches created by a RR line and a control line were infused with fluorescently dyed water until leak and/or burst was observed from each staple line, and the corresponding pressures were recorded. Study performed by Covidien in 2010. 

6.AcuteFreeBleed/HemostasisComparisonbetweenRadialReload,Tri-staple60AMT,andCONTOUR®Stapler. Staplers were fired into 2 canines bowel and colon, if bleeding occurred at the cut line, the blood was collected and weighed using blotting paper. Study performed by Covidien in 2010. 

7.PnuemostasisComparisonbetweenRadialReloadandTri-Staple60AMT. Staplerswerefiredinto2caninesand4porcine lung tissue, the lungs were inflated to 15, 20, 30, and 40 cm H2O and air leaks were observed and ranked. Study performed by Covidien in 2010.

8. 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 (data on file).

9. 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; data on file).

† Benefits are due to graduated tissue compression technology. Device is not software controlled.

‡ Not launching until FY13

Always refer to Product Instructions for Use for complete indications, contraindications, warnings, precautions and instructions

*Ethicon Contour® is a registered trademark of Ethicon Endo-Surgery, Inc.

References