Ethicon Edge Competitive Performance Testing · Competitive Performance Testing *Overall Strength,...

Ethicon EdgeCompetitive PerformanceTesting

Wound Closure2018

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Table of Contents

Sutures

ETHIBOND EXCEL® Polyester Suture . . . . . . 26-29

MONOCRYL® (poliglecaprone 25) Suture. . 30-31

PDS® (polydioxanone) Suture . . . . . . . . . . . . . . . . XX

PROLENE® Polypropylene Suture . . . . . . . . 32-40

Coated VICRYL® (polyglactin 910) Suture and Coated VICRYL® Plus Antibacterial (polyglactin 910) Suture . . . . . . . . . . . . . . . . . . 41-55

VICRYL RAPIDE™ (polyglactin 910) Suture . . XX

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device . . . . . . . . . . . . . . 56

STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device . . . . . . . . . . . . 57-58

STRATAFIX™ Spiral MONOCRYL™ PlusKnotless Tissue Control Device . . . . . . . . . . . . . . 58

Regional Sutures

ETHIBOND EXCEL Suture (Asia-Pacific) . . . . 59

Suture Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Topical Skin Adhesives

DERMABOND ADVANCED® Topical Skin Adhesive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

DERMABOND® PRINEO® SkinClosure System (22 cm) . . . . . . . . . . . . . . . . . . . . . . 62

Advanced Suturing Systems

PROXISURE™ Suturing Device . . . . . . . . . . . . . . 63

Vascular Access Device Protection

BIOPATCH® Protective Disk with CHG . . . . 64-67

Needles

BV-1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . XX

BV130-5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

BV175-6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9

BV175-8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

C-1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-12

CC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . XX

CC-1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . XX

CT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-14

CT-1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-16

FS-2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . XX

P-3 PRIME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . XX

PC-1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . XX

PS-1 PRIME. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . XX

PS-2 PRIME . . . . . . . . . . . . . . . . . . . . . . . . . . . . XX

RB-1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

SH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18-19

SH-1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . XX

V-5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . XX

V-7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

V-34 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

STRATAFIX™ Knotless Tissue Control Device Needles . . . . . . . . . . . . . . 21-24

Needle Glossary . . . . . . . . . . . . . . . . . . . . 25

Ethicon Surgical Needles

Competitive Performance Testing

*Overall Strength, measured as Bend Moment, is a product of Surgical Yield, Ultimate Moment, Reshape, and Stiffness characteristics.

Reference: Technical Memo CT17-001. BV130-5 Competitive Assessment. February 10, 2017. Ethicon, Inc. 3

PENETRATION FORCE COMPARISON• BV130-5 EVERPOINT (EVP)

required less penetration

force than MV-135-5 from

1 to 30 passes

• BV130-5 EVERPOINT (EVP)

showed less variability in

penetration force than

MV-135-5 from 1 to 30

passes


displayed greater strength

than MV-135-5 regardless

of the angle at which force

was applied

Testing Outcomes

Ethicon Needle Alloy Code

EVERPOINT (EVP) BV130-5

Competitor Code

Medtronic MV-135-5

PENETRATION FORCE STANDARD DEVIATION

Pe

ne

tra

tio

n F

orc

e (

gra

ms)

Pass

70

60

50

40

30

20

10

0

MEDTRONIC, MV-135-5

ETHICON, BV130-5 (EVP)

1 10 20 30

GOOD

MEDTRONIC, MV-135-5


GOOD

Sta

nd

ard

De

via

tio

n

Pass1 10 20 30

Less penetration force required

Less variability in penetration force

Greater strength regardless of angle*

✓✓✓

1.2

3.0

8.0

6.6

5.0

1.3 1.4 1.5

STRENGTH COMPARISON

Be

nd

Mo

me

nt

(gra

m •

cm

)

Angle (degrees)

MEDTRONIC, MV-135-5


30

25

20

15

10

5

0 GOOD

0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90





PENETRATION FORCE COMPARISON

STRENGTH COMPARISON



force than 2xDR6 from

1 to 30 passes


showed less variability

in penetration force than

2xDR6 from 1 to 30 passes


displayed greater (0-40º)

or statistically equivalent

(45-90º) strength

compared to 2xDR6

Testing Outcomes



Competitor Code

B. Braun 2xDR6


Pe

ne

tra

tio

n F

orc

e (

gra

ms)

Pass

60

50

40

30

20

10

0

B. BRAUN, 2xDR6


1 10 20 30

GOOD

B. BRAUN, 2xDR6


GOOD

Sta

nd

ard

De

via

tio

n

Pass1 10 20 30



Greater or statistically equivalent strength*

✓✓✓

1.2

3.3

8.5

6.66.0

1.3 1.4 1.5

Be

nd

Mo

me

nt

(gra

m •

cm

)

Angle (degrees)

B. BRAUN, 2xDR6


30

25

20

15

10

5

0 GOOD

0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90




PENETRATION FORCE COMPARISON• BV130-5 required less


MV-135-5 from 1 to 30

passes

Testing Outcomes


ETHALLOY BV130-5

Competitor Code

Medtronic MV-135-5

Pe

ne

tra

tio

n F

orc

e (

gra

ms)

Pass

60

50

40

30

20

10

0

MEDTRONIC, MV-135-5

ETHICON, BV130-5

1 10 20 30

BETTER

Less penetration force required✓



2xDR6 from 1 to 30 passes

Testing Outcomes


ETHALLOY BV130-5

Competitor Code

B. Braun 2xDR6

Pe

ne

tra

tio

n F

orc

e (

gra

ms)

Pass

60

50

40

30

20

10

0

B. BRAUN, 2xDR6

ETHICON, BV130-5

1 10 20 30

BETTER





Reference: Technical Memo CT16-001. BV175-6 Competitive Assessment. July 19, 2016. Ethicon, Inc. 6

STRENGTH COMPARISON




1 to 30 passes




MV-175-8 from 1 to 30

passes





was applied

Testing Outcomes



Competitor Code

Medtronic MV-175-8


Pe

ne

tra

tio

n F

orc

e (

gra

ms)

Pass

90

80

70

60

50

40

30

20

10

0

MEDTRONIC, MV-175-8, 8 mil

ETHICON, BV175-6 (EVP), 8 mil

1 10 20 30

GOOD

Be

nd

Mo

me

nt

(gra

m •

cm

)

Angle (degrees)



70

60

50

40

30

20

10

00 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90

GOOD


ETHICON, BV175-6 (EVP), 8 milGOOD

Sta

nd

ard

De

via

tio

n

Pass1 10 20 30




✓✓✓

2.5

4.9

8.57.6 7.4

2.3 2.2 2.2



Reference: Technical Memo CT16-001. BV175-6 Competitive Assessment. July 19, 2016. Ethicon, Inc. 7

Pe

ne

tra

tio

n F

orc

e (

gra

ms)

Pass

90

80

70

60

50

40

30

20

10

0


ETHICON, BV175-6, 8 mil

1 10 20 30

• BV175-6 required less


MV-175-8 from 1 to 30

passes

• BV175-6 showed less

variability in penetration


1 to 30 passes

Testing Outcomes

GOOD




GOOD

Sta

nd

ard

De

via

tio

n

Pass

1 10 20 30



ETHALLOY BV175-6

Competitor Code

Medtronic MV-175-8



✓✓

2.3

4.9

8.57.6 7.4

4.05.1

5.9


Reference: Technical Memo CT16-004. BV175-6 Competitive Assessment. August 23, 2016. Ethicon, Inc. 8

STRENGTH COMPARISON




DR8f from 1 to 30 passes



than DR8f regardless of

the angle at which force

was applied


Be

nd

Mo

me

nt

(gra

m •

cm

)

Angle (degrees)

B. BRAUN, DR8f, 8 mil


70

60

50

40

30

20

10

00 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90

GOOD


ETHICON, BV175-6 (EVP), 8 milGOOD

Sta

nd

ard

De

via

tio

n

Pass1 10 20 30

2.5

7.3

9.0 9.4 9.3

2.3 2.3 2.2



force than DR8f from 1 to

30 passes

Testing Outcomes

Competitor Code

B. Braun DR8f

Pe

ne

tra

tio

n F

orc

e (

gra

ms)

Pass

80

70

60

50

40

30

20

10

0



1 10 20 30

GOOD




✓✓✓


Competitive Performance TestingEthicon Needle Alloy Code


Reference: Technical Memo CT16-004. BV175-6 Competitive Assessment. August 23, 2016. Ethicon, Inc. 9

• BV175-6 showed less


force than DR8f from 1 to

30 passes




GOOD

Sta

nd

ard

De

via

tio

n

Pass1 10 20 30

2.3

7.3

9.0 9.4 9.3

4.05.1

5.9



DR8f from 1 to 30 passes

Testing Outcomes

Competitor Code

B. Braun DR8f

Pe

ne

tra

tio

n F

orc

e (

gra

ms)

Pass

80

70

60

50

40

30

20

10

0



1 10 20 30

GOOD



✓✓


Competitive Performance TestingEthicon Needle Alloy Code

ETHALLOY BV175-6

10

STRENGTH COMPARISON

Be

nd

Mo

me

nt

(gra

m •

cm

)

Angle (degrees)

70

60

50

40

30

20

10

00 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90

GOOD


Reference: Technical Memo CT16-002. BV175-8 Competitive Assessment. July 19, 2016. Ethicon, Inc.


Pe

ne

tra

tio

n F

orc

e (

gra

ms)

Pass

100

90

80

70

60

50

40

30

20



1 10 20 30




1 to 30 passes




MV-175-9 from 1 to 30

passes





was applied

Testing Outcomes

GOOD





GOOD

Sta

nd

ard

De

via

tio

n

Pass1 10 20 30




Competitor Code

Medtronic MV-175-9




✓✓✓



2.6

5.0

8.2

6.8 6.5

2.5 2.6 2.7

11

• C-1 displayed greater

(35-90º) or statistically

equivalent (0-30º)

strength compared

to CV-11

Testing Outcomes

STRENGTH COMPARISON

Be

nd

Mo

me

nt

(gra

m •

cm

)

Angle (degrees)

250

200

150

100

50

00 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90

GOOD

MEDTRONIC, CV-11

ETHICON, C-1


ETHALLOY C-1

Competitor Code

Medtronic CV-11

Greater or statistically equivalent strength*✓




Reference: Technical Memo CT17-006. C-1 Competitive Assessment. May 20, 2017. Ethicon, Inc.

12


Pe

ne

tra

tio

n F

orc

e (

gra

ms)

Pass

110

105

100

95

90

85

80

75

70

65

60

55

50

45

40

B. BRAUN, DR12

ETHICON, C-1

1 10 20 30

• C-1 required less

penetration force

than DR12 from

1 to 30 passes

• C-1 displayed greater

strength than DR12

regardless of the angle at

which force was applied

Testing Outcomes

GOOD


ETHALLOY C-1

Competitor Code

B. Braun DR12

Less penetration force required✓Greater strength regardless of angle*✓




Reference: Technical Memo CT17-006. C-1 Competitive Assessment. May 20, 2017. Ethicon, Inc.

STRENGTH COMPARISON

Be

nd

Mo

me

nt

(gra

m •

cm

)

Angle (degrees)

250

200

150

100

50

00 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90

GOOD

B. BRAUN, DR12

ETHICON, C-1




Reference: Technical Memo CT16-005. CT Competitive Assessment. October 17, 2016. Ethicon, Inc. 13

STRENGTH COMPARISON

PENETRATION FORCE COMPARISON• CT required less

penetration force

than GS-24 from

1 to 30 passes

• CT showed less variability


GS-24 from 1 to 30 passes

• CT displayed greater

strength than GS-24



Testing Outcomes

Competitor Code

Medtronic GS-24


Pe

ne

tra

tio

n F

orc

e (

gra

ms)

Pass

250

200

150

100

50

0

ETHICON, CT

MEDTRONIC, GS-24

1 10 20 30

GOOD

Be

nd

Mo

me

nt

(gra

m •

cm

)

Angle (degrees)

MEDTRONIC, GS-24

ETHICON, CT

6000

5000

4000

3000

2000

1000

00 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90

GOOD

MEDTRONIC, GS-24

ETHICON, CT

GOOD

Sta

nd

ard

De

via

tio

n

Pass1 10 20 30




✓✓✓

8.9

23.7

32.7 34.1 34.8

16.019.0

22.0

6.5


Stainless Steel CT




Reference: Technical Memo CT16-005. CT Competitive Assessment. October 17, 2016. Ethicon, Inc. 14

STRENGTH COMPARISON

PENETRATION FORCE COMPARISON• CT required less

penetration force

than HR40s from

1 to 30 passes

• CT showed less variability


HR40s from 1 to 30 passes

• CT displayed greater

strength than HR40s



Testing Outcomes

Competitor Code

B. Braun HR40s


Pe

ne

tra

tio

n F

orc

e (

gra

ms)

Pass

250

200

150

100

50

0

ETHICON, CT

B.BRAUN, HR40s

1 10 20 30

GOOD

Be

nd

Mo

me

nt

(gra

m •

cm

)

Angle (degrees)

B.BRAUN, HR40s

ETHICON, CT

6000

5000

4000

3000

2000

1000

00 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90

GOOD

B.BRAUN, HR40s

ETHICON, CTGOOD

Sta

nd

ard

De

via

tio

n

Pass1 10 20 30




✓✓✓

8.910.5

19.020.1

22.3

16.019.0

22.0


Stainless Steel CT




Reference: Technical Memo CT16-006. CT-1 Competitive Assessment. December 13, 2016. Ethicon, Inc. 15

STRENGTH COMPARISON

PENETRATION FORCE COMPARISON• CT-1 required less

penetration force

than GS-21 from

1 to 30 passes

• CT-1 showed less variability


GS-21 from 1 to 30 passes

• CT-1 displayed greater

strength than GS-21



Testing Outcomes

Competitor Code

Medtronic GS-21


Pe

ne

tra

tio

n F

orc

e (

gra

ms)

Pass

300

250

200

150

100

50

0

MEDTRONIC, GS-21

ETHICON, CT-1

1 10 20 30

GOOD

Be

nd

Mo

me

nt

(gra

m •

cm

)

Angle (degrees)

MEDTRONIC, GS-21

ETHICON, CT-13500

3000

2500

2000

1500

1000

500

00 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90

GOOD

MEDTRONIC, GS-21

ETHICON, CT-1

GOOD

Sta

nd

ard

De

via

tio

n

Pass1 10 20 30




✓✓✓

11.3

27.230.0

28.7 28.4

17.9 20.924.8


Stainless Steel CT-1



Reference: Technical Memo CT16-006. CT-1 Competitive Assessment. December 13, 2016. Ethicon, Inc. 16

PENETRATION FORCE COMPARISON• CT-1 required less

penetration force

than HR37s from

1 to 30 passes

Testing Outcomes

Competitor Code

B. Braun HR37s

Pe

ne

tra

tio

n F

orc

e (

gra

ms)

Pass

300

250

200

150

100

50

0

B. BRAUN, HR37s

ETHICON, CT-1

1 10 20 30

GOOD







Reference: Technical Memo CT17-005. RB-1 Competitive Assessment. April 20, 2017. Ethicon, Inc. 17

STRENGTH COMPARISON• RB-1 displayed greater

strength than CV-23



Testing Outcomes

Competitor Code

Medtronic CV-23

Be

nd

Mo

me

nt

(gra

m •

cm

)

Angle (degrees)

MEDTRONIC, CV-23

ETHICON, RB-1300

250

200

150

100

50

0

0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90

GOOD

Greater strength regardless of angle*✓


ETHALLOY RB-1



18

STRENGTH COMPARISON

PENETRATION FORCE COMPARISON• SH required less

penetration force

than V-20 from

1 to 30 passes

• SH displayed greater

strength than V-20

regardless of the angle

at which force was applied

Testing Outcomes

Competitor Code

Medtronic V-20

Pe

ne

tra

tio

n F

orc

e (

gra

ms)

Pass

160

140

120

100

80

60

40

20

0

MEDTRONIC, V-20

ETHICON, SH

1 10 20 30

GOOD

Be

nd

Mo

me

nt

(gra

m •

cm

)

Angle (degrees)

MEDTRONIC, V-20

ETHICON, SH

1200

1000

800

600

400

200

0

0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90

GOOD



✓✓


Reference: Technical Memo CT17-003. SH Needle Competitive Assessment. March 20, 2017. Ethicon, Inc.


Stainless Steel SH



Reference: Technical Memo CT17-009. SH Competitive Assessment. September 26, 2017. Ethicon, Inc. 19

• SH showed less variability


HR26 from 1 to 30 passes

Competitor Code

B. Braun HR26



✓✓


Stainless Steel SH

• SH required less


HR26 from 1 to 10 passes

Testing OutcomesPENETRATION FORCE COMPARISON

Pe

ne

tra

tio

n F

orc

e (

gra

ms)

Pass

145

140

135

130

125

120

115

110

105

100

95

90

85

80

75

B. BRAUN, HR26

ETHICON, SH

1 10 20 30

GOOD


B. BRAUN, HR26

ETHICON, SHGOOD

Sta

nd

ard

De

via

tio

n

Pass1 10 20 30

5.4

7.6

11.110.6

10.210.4 9.89.5



Reference: Technical Memo CT18-003. V-34 Competitive Assessment. April 3, 2018. Ethicon, Inc.

Reference: Technical Memo CT18-001. V-7 Competitive Assessment. February 15, 2018. Ethicon, Inc.

20

Competitor Code

Medtronic KV-7



Stainless Steel V-7

• V-7 required less


KV-7 from 1 to 30 passes

Testing Outcomes

PENETRATION FORCE COMPARISONP

en

etr

ati

on

Fo

rce

(g

ram

s)

Pass

150

145

140

135

130

125

120

115

110

105

100

95

90

85

80

75

MEDTRONIC, KV-7

ETHICON, V-7

1 10 20 30

GOOD


• V-34 required less penetration

force than Meril Endo-Surgery 40

mm from 1 to 30 passes

Testing Outcomes

Competitor Code

Meril Endo-Surgery 40 mm


Stainless Steel V-34


Pe

ne

tra

tio

n F

orc

e (

gra

ms)

Pass

380

360

340

320

300

280

260

240

220

200

MERIL, ENDO-SURGERY 40 MM

ETHICON, V-34

1 10 20 30

GOOD

Ethicon Surgical Needles | STRATAFIX



Reference: Technical Memo CT12-009. December 12, 2012. Ethicon, Inc.

• STRATAFIX CT-1 displayed

greater strength than

V-Loc™ GS-21 regardless of

the angle at which force

was applied

Testing Outcomes

Competitor Code

Medtronic V-Loc™ GS-21

Greater strength regardless of angle*✓

STRENGTH COMPARISON

To

rqu

e (g

ram

• c

m)

Angle (degrees)

MEDTRONIC, V-Loc™ GS-21, 39 mil

ETHICON, STRATAFIX CT-1, 40 mil

4000

3500

3000

2500

2000

1500

1000

500

00 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90

GOOD






Competitor Code

Medtronic V-Loc™ GS-25



✓✓

PENETRATION FORCE COMPARISON• STRATAFIX CTX required

less penetration force than

V-Loc™ GS-25 from 1 to

30 passes

• STRATAFIX CTX


in penetration force

than V-Loc™ GS-25 from

1 to 30 passes

Testing Outcomes


Pe

ne

tra

tio

n F

orc

e (

gra

ms)

Pass

ETHICON, STRATAFIX CTX, 50 mil


1 10 20 30

GOOD


ETHICON, STRATAFIX CTX, 50 milGOOD

Sta

nd

ard

De

via

tio

n

Pass1 10 20 30

12.0

27.7

44.349.1

55.0

18.522.2 24.1

350

300

250

200

150

100

50

0


Stainless Steel CTX




Competitor Code

Quill DE-14



✓✓

PENETRATION FORCE COMPARISON• STRATAFIX FS required

less penetration force than

Quill DE-14 from 1 to 30

passes

• STRATAFIX FS showed less


force than Quill DE-14 from

1 to 30 passes

Testing Outcomes


Pe

ne

tra

tio

n F

orc

e (

gra

ms)

Pass

ETHICON, STRATAFIX FS, 29 mil

QUILL, DE-14, 28 mil

1 10 20 30

GOOD


ETHICON, STRATAFIX FS, 29 mil

GOOD

Sta

nd

ard

De

via

tio

n

Pass

1 10 20 30

10.0

20.6 21.5 21.7 22.5

10.9 10.4 11.1

250

200

150

100

50

0


Stainless Steel FS




Reference: Technical Memo CT09-022. January 20, 2010. Ethicon, Inc.

STRENGTH COMPARISON

PENETRATION FORCE COMPARISON• STRATAFIX FS-2


force than Quill DE-12

from 1 to 30 passes

• STRATAFIX FS-2


in penetration force

than Quill DE-12 from

1 to 30 passes

• STRATAFIX FS-2


than Quill DE-12 regardless


was applied

Testing Outcomes

Competitor Code

Quill DE-12


Pe

ne

tra

tio

n F

orc

e (

gra

ms)

Pass

160

140

120

100

80

60

40

20

0


ETHICON, STRATAFIX FS-2, 24 mil

1 10 20 30

GOOD

To

rqu

e (g

ram

• c

m)

Angle (degrees)



1200

1000

800

600

400

200

00 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90

GOOD



GOOD

Sta

nd

ard

De

via

tio

n

Pass1 10 20 30




✓✓✓

8.0

13.5

11.0 11.4 10.7

5.4

7.68.3


Stainless Steel FS-2

Needle Glossary

Surgical Yield

Needles will flex under pressure or load. When the pressure

is released, the needle will ‘spring back’ to its original shape.

When the pressure on the needle becomes too great, the

needle will fail to return to its original shape. This is known

as Surgical Yield. Needle alloy, wire diameter, needle-body

geometry, and heat treatment during manufacturing are

all factors that can affect a needle's ability to resist pressure.

In more scientific terms, Surgical Yield may be defined

as the amount of Moment required to initiate plastic

deformation during bend tests. (ASTM standard F-1840-98a)

Refer to Graph.

Ultimate Moment

In lab tests, a curved needle is subjected to an increasing

pressure until the needle is bent 90º. The amount of

pressure the needle can resist until it bends 90º is referred

to as the Ultimate Moment. In more scientific terms,

Ultimate Moment is defined as the maximum Moment

applied during bend tests. (ASTM standard F-1840-98a)

Refer to Graph.

Width

I-BEAM SQUARE BODY

Height

NEEDLE BODY GEOMETRY

CROSS-SECTIONS

Be

nd

Mo

me

nt

(ne

wto

ns

• cm

)

Angular Deflection (degrees)

ElasticRegion

Surgical Yield

UltimateMoment

0 10 20 30 40 50 60 70 80 90

Graph

REPRESENTATION OF

NEEDLE STRENGTH PROFILES

I-Beam Body

This refers to the cross-section of the needle body.

In general terms, the height of the body is greater than the

width of the body, as shown in the illustration. If the corners

are rounded, then the body is referred to as a round corner

I-beam.

Square Body

This refers to the cross-section of the needle body.

In general terms, the height of the body is equal to the

width of the body, as shown in the illustration.

Ductility

Ductility is the ability of a needle to resist breaking while being bent under pressure. If a needle lacks ductility, it may break

when pressure is exerted upon it. If a needle is ductile, the needle will bend under pressure before it will break. Needle

designs aim to make a needle as strong as possible to resist bending, while also imparting ductility so it can bend when the

force applied becomes too strong. A test known as a Reshape Test determines the ductility of a needle. In this test, a needle

is bent 90º and then bent back to its original shape (or as close as the needle will allow). The more times a needle can be

bent in this manner, the greater the needle’s ability to resist breaking. Refer to Graph.

7

6

5

4

3

2

1

0

Ethicon Sutures


Reference: Technical Report PE-2017-0012. July 14, 2017. Ethicon, Inc.26

• 2-0 ETHIBOND EXCEL Suture displayed greater straight

tensile strength than 2-0 Ti-Cron™ Suture

• 2-0 ETHIBOND EXCEL Suture displayed less package

memory than 2-0 Ti-Cron™ Suture

Testing Outcomes

Competitor

Medtronic 2-0 Ti-Cron™ Suture

Greater straight tensile strength✓

Less package memory✓Greater controlled linear elongation✓Greater knot security✓

ETHICON, 2-0 ETHIBOND

MEDTRONIC, 2-0 Ti-Cron

14.0013.32


MEDTRONIC, 2-0 Ti-Cron 6.8710.20

Straight Tensile Strength (lbs)

Package Memory - Short Pack (%)

Controlled Linear Elongation (%)

• 2-0 ETHIBOND EXCEL Suture displayed greater

controlled linear elongation than 2-0 Ti-Cron™ Suture



13.9412.79

Knot Security Occurrences (%)

• 2-0 ETHIBOND EXCEL Suture displayed greater knot

security compared to 2-0 Ti-Cron™ SutureETHICON, 2-0 ETHIBOND


80

72

Ethicon Suture

2-0 ETHIBOND EXCEL® Polyester Suture

Ethicon Sutures


Reference: Technical Report PE-2017-0012. July 14, 2017. Ethicon, Inc.27

• 2-0 ETHIBOND EXCEL Suture displayed greater straight

tensile strength than 2-0 PremiCron® Suture

Testing Outcomes

Ethicon Suture


Competitor

B. Braun 2-0 PremiCron® Suture


Greater intrinsic straight tensile strength✓

Less package memory✓

Greater controlled linear elongation✓

More reliable knot slide✓


B. BRAUN, 2-0 Premicron

14.0012.40


• 2-0 ETHIBOND EXCEL Suture displayed less package

memory than 2-0 PremiCron® Suture



6.87

13.63


• 2-0 ETHIBOND EXCEL Suture displayed greater intrinsic

straight tensile strength than 2-0 PremiCron® Suture



103.6

94.7

Intrinsic Straight Tensile Strength (kpsi)


• 2-0 ETHIBOND EXCEL Suture displayed greater

controlled linear elongation than 2-0 PremiCron® Suture



13.9412.89

Knot Slide Occurrences (%)

• 2-0 ETHIBOND EXCEL Suture displayed more reliable

knot slide compared to 2-0 PremiCron® SutureETHICON, 2-0 ETHIBOND


100

67

Reference: Technical Report PE-2017-0023. October 2, 2017. Ethicon, Inc. 28

Ethicon Sutures

Competitive Performance TestingEthicon Suture


Competitor

Medtronic 4-0 Ti-Cron™ Suture


• 4-0 ETHIBOND EXCEL Suture

displayed less package memory

than 4-0 Ti-Cron™ Suture

Testing Outcomes

5.307.43

Package Memory – Short Pack (%)



✓


Ethicon Sutures


119.91 115.86


Ethicon Suture


Competitor

B. Braun 4-0 PremiCron® Suture

Greater intrinsic straight tensile strength✓Less package memory✓Greater controlled linear elongation✓More reliable knot slide✓


displayed greater intrinsic

straight tensile strength than

4-0 PremiCron® Suture

Testing Outcomes ETHICON, 4-0 ETHIBOND


5.30

10.57

10.96 10.09





than 4-0 PremiCron® Suture


displayed greater controlled

linear elongation than 4-0

PremiCron® Suture





10087



displayed more reliable knot

slide compared to 4-0

PremiCron® Suture



4.763.00

136.46

87.55

• 5-0 MONOCRYL Suture displayed

greater straight tensile strength

than 5-0 Caprosyn™ Suture


greater intrinsic straight tensile

strength than 5-0 Caprosyn™ Suture

Testing Outcomes

Greater intrinsic straight tensile strength✓Greater straight tensile strength✓

Greater knot tensile strength✓

ETHICON, 5-0 MONOCRYL

MEDTRONIC, 5-0 Caprosyn





Reference: Technical Report PE-2017-0031. October 2, 2017. Ethicon, Inc.

Ethicon Sutures


30

Ethicon Suture

5-0 MONOCRYL® (poliglecaprone 25) Suture

Competitor

Medtronic 5-0 Caprosyn™ Suture


More reliable knot slide✓

11.90

51.37

2.25 1.80


greater knot tensile strength than

5-0 Caprosyn™ Suture



Knot Tensile Strength (lbs)

• 5-0 MONOCRYL Suture


than 5-0 Caprosyn™ Suture




100

83• 5-0 MONOCRYL Suture

displayed more reliable

knot slide compared to

5-0 Caprosyn™ Suture




4.763.71


greater straight tensile strength

than 5-0 Monosyn® Suture




5-0 Monosyn® Suture

Testing Outcomes

Greater straight tensile strength✓Greater intrinsic straight tensile strength✓Less package memory ✓


B. BRAUN, 5-0 Monosyn



136.46

91.80




Ethicon Sutures


5-0 MONOCRYL® (poliglecaprone 25) Suture

Competitor

B. Braun 5-0 Monosyn® Suture



than 5-0 Monosyn® Suture



11.90

39.07


Ethicon Sutures


Reference: Technical Report PE-2016-0020. July 21, 2017. Ethicon, Inc. 32

• 5-0 PROLENE Suture displayed less package memory

than 5-0 Optilene™ Suture

• 5-0 PROLENE Suture displayed greater controlled linear

elongation than 5-0 Optilene™ Suture

Testing Outcomes

Ethicon Suture

5-0 PROLENE® Polypropylene Suture

Competitor

B. Braun 5-0 Optilene™ Suture (Non-Absorbable)



ETHICON, 5-0 PROLENE

B. BRAUN, 5-0 Optilene

40.3

47.0



35.231.6




elongation than 5-0 Surgipro™ II Suture

Testing Outcomes

Ethicon Suture


Competitor

Medtronic 5-0 Surgipro™ II Polypropylene Monofilament Suture



MEDTRONIC 5-0 Surgipro II

35.230.7


Ethicon Sutures


Reference: Technical Report PE-2016-0020. July 21, 2017. Ethicon, Inc. 33

• 5-0 PROLENE Suture displayed greater straight tensile

strength than 5-0 Premilene® Suture

Testing Outcomes

Ethicon Suture


Competitor

B. Braun 5-0 Premilene® Suture (Non-Absorbable)


B. BRAUN, 5-0 Premilene

2.21 1.86



Greater knot tensile strength✓Greater intrinsic straight tensile strength✓


• 5-0 PROLENE Suture displayed greater knot tensile

strength than 5-0 Premilene® SutureETHICON, 5-0 PROLENE

B. BRAUN, 5-0 Premilene 1.75 1.53Knot Tissue Strength (lbs)

• 5-0 PROLENE Suture displayed greater intrinsic straight

tensile strength than 5-0 Premilene® Suture ETHICON, 5-0 PROLENE


84.672.7




than 5-0 Premilene® Suture


B. BRAUN, 5-0 Premilene 40.3 43.4

Ethicon Sutures


Reference: Technical Report PE-2016-0020. October 19, 2016. Ethicon, Inc.34


than 6-0 Optilene™ Non-Absorbable Suture


elongation than 6-0 Optilene™ Non-Absorbable Suture

Testing Outcomes

Ethicon Suture


Competitor

B. Braun 6-0 Optilene™ Non-Absorbable Suture


B. BRAUN, 6-0 Optilene25.2

37.6




36.2

28.9


Less package memory

Greater controlled linear elongation

✓✓


elongation than 6-0 Surgipro™ II Suture

Testing Outcomes

Ethicon Suture


Competitor




MEDTRONIC, 6-0 Surgipro II

36.231.8


Ethicon Sutures



Ethicon Suture


Competitor




Testing OutcomesETHICON, 6-0 PROLENE


1.060.79





0.86 0.78





Greater controlled linear elongation✓Less package memory ✓




tensile strength than 6-0 Premilene® Suture



86.270.7



B. BRAUN, 6-0 Premilene25.234.1



elongation than 6-0 Premilene® SutureETHICON, 6-0 PROLENE


36.2

26.7


Ethicon Sutures


Reference: Technical Report PE-2016-0020. November 8, 2016. Ethicon, Inc.36





Testing Outcomes

Ethicon Suture


Competitor




Less package memory✓Greater controlled linear elongation✓



0.620.46


B. BRAUN, 7-0 Premilene0.50 0.44




B. BRAUN, 7-0 Premilene7.5

9.7


elongation than 7-0 Premilene® Suture








99.881.6




29.325.2


Ethicon Sutures


Reference: Technical Report PE-2016-0020. February 1, 2017. Ethicon, Inc.37





Testing Outcomes

Ethicon Suture


Competitor




132.9123.6



122.489.3

Straight Tensile Strength (gram-force)



strength than 8-0 Premilene® SutureETHICON, 8-0 PROLENE


107.7 101.6

Knot Tensile Strength (gram-force)

Greater straight tensile strength✓Greater intrinsic straight tensile strength✓Greater knot tensile strength✓

Ethicon Sutures



• 8-0 OS PROLENE Suture displayed greater straight tensile

strength than 8-0 Optilene™ Suture

• 8-0 OS PROLENE Suture displayed greater knot tensile

strength than 8-0 Optilene™ Suture

Testing Outcomes

Ethicon Suture

8-0 Oversized (OS) PROLENE® Polypropylene Suture

Competitor

B. Braun 8-0 Optilene™ Non-Absorbable Suture

ETHICON, 8-0 OS PROLENE


217.5161.1



167.4112.9



• 8-0 OS PROLENE Suture displayed greater controlled

linear elongation than 8-0 Optilene™ SutureETHICON, 8-0 OS PROLENE


35.6824.42


Greater straight tensile strength✓Greater knot tensile strength✓Greater controlled linear elongation✓

Ethicon Sutures





• 8-0 OS PROLENE Suture displayed greater intrinsic

straight tensile strength than 8-0 Premilene® Suture

Testing Outcomes

Ethicon Suture


Competitor







217.5

123.6



109.289.3



• 8-0 OS PROLENE Suture displayed greater knot




167.4

101.6


Ethicon Sutures







strength than 8-0 Surgipro™ II Suture

• 8-0 OS PROLENE Suture displayed greater intrinsic

straight tensile strength than 8-0 Surgipro™ II Suture

Testing Outcomes

Ethicon Suture


Competitor




217.5

173.8


MEDTRONIC, 8-0 Surgipro II109.2 104.0



• 8-0 OS PROLENE Suture displayed greater knot tensile

strength than 8-0 Surgipro™ II Suture



167.4134.8


• Size 1 VICRYL Suture

displayed greater straight

tensile strength than

size 1 Novosyn® Suture


displayed greater knot



Testing Outcomes




ETHICON, Size 1 VICRYL

B. BRAUN, Size 1 Novosyn

28.74 27.61



15.39 13.91





straight tensile strength

than size 1 Novosyn® Suture



94.9

84.5



displayed less package

memory than size 1

Novosyn® Suture



19.87

30.87


Reference: Technical Report PE-2017-0019. September 25, 2017. Ethicon, Inc.

Ethicon Sutures


41

Ethicon Suture

Size 1 Coated VICRYL® (polyglactin 910) Suture

Competitor

B. Braun Size 1 Novosyn® Suture

28.75 27.61

ETHICON, Size 1 VICRYL Plus


Reference: Technical Report PE-2017-0019. September 25, 2017. Ethicon, Inc. 42

Ethicon Sutures


Size 1 Coated VICRYL® Plus Antibacterial

(polyglactin 910) Suture

Competitor


• Size 1 VICRYL Plus Suture








Testing Outcomes

Greater straight tensile strength✓Greater intrinsic straight tensile strength✓

Greater knot tensile strength ✓





88.084.5








15.13 13.91

• Size 1 VICRYL Suture displayed

greater intrinsic straight tensile

strength than size 1 MITSU AB™

Suture


displayed greater in vivo

breaking strength retention

(BSR) at 14, 21, and 28 days

compared to size 1 MITSU

AB™ Suture

Testing Outcomes

Greater intrinsic straight tensile strength✓Greater in vivo breaking strength retention✓Greater controlled linear elongation✓More reliable knot slide✓


MERIL, Size 1 MITSU AB



94.989.4




linear elongation than size 1

MITSU AB™ Suture



23.7

18.0




97

0





size 1 MITSU AB™ Suture

Reference: Technical Report PE-2017-0039. April 17, 2018. Ethicon, Inc.

Ethicon Sutures


43

Ethicon Suture


Competitor

Meril Size 1 MITSU AB™ Suture

14 Days 21 Days 28 Days

22.615.7

9.9

18.2

0.0

10.5

In Vivo BSR Load (lbs)


displayed greater in vivo

breaking strength retention

(BSR) at 14, 21, and 28 days

compared to size 1 MITSU

AB™ Suture



linear elongation than size 1

MITSU AB™ Suture

Testing Outcomes

Greater in vivo breaking strength retention✓Greater controlled linear elongation✓More reliable knot slide✓




size 1 MITSU AB™ Suture

Reference: Technical Report PE-2017-0039. April 17, 2018. Ethicon, Inc.

Ethicon Sutures


44

Ethicon Suture

Size 1 Coated VICRYL® Plus Antibacterial

(polyglactin 910) Suture

Competitor

Meril Size 1 MITSU AB™ Suture



14 Days 21 Days 28 Days

20.615.7

9.9

14.6

0.05.2

In Vivo BSR Load (lbs)



100

0



MERIL, Size 1 MITSU AB23.918.0


Ethicon Sutures



• Size 0 VICRYL Suture displayed greater

intrinsic straight tensile strength than

size 0 Polysorb™ Suture

Testing Outcomes

Ethicon Suture


Competitor

Medtronic Size 0 Polysorb™ Suture

Greater intrinsic straight tensile strength✓Less package memory✓More reliable knot slide✓


MEDTRONIC, Size 0 Polysorb

109.8102.7



less package memory than

size 0 Polysorb™ Suture


MEDTRONIC, Size 0 Polysorb 11.80

18.93



more reliable knot slide compared

to size 0 Polysorb™ SutureETHICON, Size 0 VICRYL


100

53


Ethicon Sutures



• Size 0 VICRYL Suture displayed greater intrinsic straight

tensile strength than size 0 Novosyn® Suture

Testing Outcomes

Ethicon Suture


Competitor


Greater knot tensile strength✓Less package memory✓


Greater knot security✓



109.8103.0


• Size 0 VICRYL Suture displayed greater knot tensile

strength than size 0 Novosyn® SutureETHICON, Size 0 VICRYL

B. BRAUN, Size 0 Novosyn11.53 11.04


• Size 0 VICRYL Suture displayed less package memory

than size 0 Novosyn® Suture



11.80

28.80


• Size 0 VICRYL Suture displayed greater knot security

compared to size 0 Novosyn® Suture



8273


Ethicon Sutures



Greater intrinsic straight tensile strength✓More reliable knot slide✓

• Size 0 VICRYL Plus Suture displayed more reliable

knot slide compared to size 0 Polysorb™ Suture


MEDTRONIC, Size 0 Polysorb53


• Size 0 VICRYL Plus Suture displayed greater intrinsic

straight tensile strength than size 0 Polysorb™ Suture

Testing Outcomes

Ethicon Suture

Size 0 Coated VICRYL® Plus Antibacterial (polyglactin 910) Suture

Competitor

Medtronic Size 0 Polysorb™ Suture



107.3 102.7


100

Ethicon Sutures



Greater straight tensile strength✓Greater intrinsic straight tensile strength✓Greater knot tensile strength✓

• Size 0 VICRYL Plus Suture displayed greater intrinsic

straight tensile strength than size 0 Novosyn® SutureETHICON, Size 0 VICRYL Plus


107.3 103.0


• Size 0 VICRYL Plus Suture displayed greater

knot tensile strength than size 0 Novosyn® SutureETHICON, Size 0 VICRYL Plus

B. BRAUN, Size 0 Novosyn11.58 11.04


• Size 0 VICRYL Plus Suture displayed greater straight

tensile strength than size 0 Novosyn® Suture

Testing Outcomes

Ethicon Suture

Size 0 Coated VICRYL® Plus Antibacterial (polyglactin 910) Suture

Competitor




23.22 22.32


Ethicon Sutures


Reference: Technical Report PE-2016-0025. December 15, 2016. Ethicon, Inc.49

Testing Outcomes

Ethicon Suture

2-0 Coated VICRYL® (polyglactin 910) Suture

Competitor

Medtronic 2-0 Polysorb™ Suture

Greater intrinsic straight tensile strength✓Less package memory✓More reliable knot slide✓

• 2-0 VICRYL Suture displayed less package memory

than 2-0 Polysorb™ Suture

ETHICON, 2-0 VICRYL

MEDTRONIC, 2-0 Polysorb 14.00

24.20


• 2-0 VICRYL Suture displayed greater intrinsic straight

tensile strength than 2-0 Polysorb™ Suture

ETHICON, 2-0 VICRYL

MEDTRONIC, 2-0 Polysorb

125.3 119.0


• 2-0 VICRYL Suture displayed more reliable knot

slide compared to 2-0 Polysorb™ SutureETHICON, 2-0 VICRYL


100

63


Ethicon Sutures



25.10

• 2-0 VICRYL Plus Suture displayed less package memory

than 2-0 Polysorb™ Suture

Testing Outcomes

Ethicon Suture

2-0 Coated VICRYL® Plus Antibacterial (polyglactin 910) Suture

Competitor


Less package memory✓More reliable knot slide✓

ETHICON, 2-0 VICRYL Plus

MEDTRONIC, 2-0 Polysorb16.3324.20


• 2-0 VICRYL Plus Suture displayed more reliable

knot slide compared to 2-0 Polysorb™ SutureETHICON, 2-0 VICRYL Plus


100

63


Ethicon Sutures



• 2-0 VICRYL Suture displayed greater straight tensile

strength than 2-0 Novosyn® Suture

• 2-0 VICRYL Suture displayed greater intrinsic straight

tensile strength than 2-0 Novosyn® Suture

Testing Outcomes

Ethicon Suture


Competitor

B. Braun 2-0 Novosyn® Suture

Greater straight tensile strength✓Greater intrinsic straight tensile strength✓Less package memory✓Greater knot security✓

ETHICON, 2-0 VICRYL

B. BRAUN, 2-0 Novosyn

16.48 16.05

ETHICON, 2-0 VICRYL


125.3 120.4



• 2-0 VICRYL Suture displayed less package memory than

2-0 Novosyn® Suture

ETHICON, 2-0 VICRYL


14.00

25.10


• 2-0 VICRYL Suture displayed greater knot security

compared to 2-0 Novosyn® SutureETHICON, 2-0 VICRYL


92

72


Ethicon Sutures



• 2-0 VICRYL Plus Suture displayed less package memory

than 2-0 Novosyn® Suture

Testing Outcomes

Ethicon Suture


Competitor


Less package memory✓Greater knot security✓



16.33

25.10




87

72


• 2-0 VICRYL Plus Suture displayed greater knot security

compared to 2-0 Novosyn® Suture

Ethicon Sutures


Reference: Technical Report PE-2016-0025. January 11, 2017. Ethicon, Inc.53

• 3-0 VICRYL Suture displayed less package

memory than 3-0 Polysorb™ Suture

Testing Outcomes

Ethicon Suture


Competitor


Less package memory✓More reliable knot slide✓

ETHICON, 3-0 VICRYL


12.17

22.03


• 3-0 VICRYL Plus Suture displayed less package

memory than 3-0 Polysorb™ Suture

Testing Outcomes

Ethicon Suture


Competitor


Less package memory✓Superior knot slide characteristics✓



17.70

22.03


ETHICON, 3-0 VICRYL


100

66



• 3-0 VICRYL Suture displayed more reliable

knot slide compared to 3-0 Polysorb™ Suture



100

66

• 3-0 VICRYL Plus Suture displayed more reliable

knot slide compared to 3-0 Polysorb™ Suture

Ethicon Sutures



• 3-0 VICRYL Suture displayed greater straight

tensile strength than 3-0 Novosyn® Suture

• 3-0 VICRYL Suture displayed greater knot tensile

strength than 3-0 Novosyn® Suture

Testing Outcomes

Ethicon Suture


Competitor


Greater straight tensile strength✓Greater intrinsic straight tensile strength✓Greater knot tensile strength✓Less package memory✓

ETHICON, 3-0 VICRYL


10.01 9.45

ETHICON, 3-0 VICRYL


5.24 4.91


• 3-0 VICRYL Suture displayed greater intrinsic

straight tensile strength than 3-0 Novosyn® Suture

ETHICON, 3-0 VICRYL


121.1111.4



• 3-0 VICRYL Suture displayed less package memory

than 3-0 Novosyn® Suture

ETHICON, 3-0 VICRYL


12.17

23.87


Ethicon Sutures



• 3-0 VICRYL Plus Suture displayed greater

straight tensile strength than 3-0 Novosyn® Suture

• 3-0 VICRYL Plus Suture displayed greater

knot tensile strength than 3-0 Novosyn® Suture

Testing Outcomes

Ethicon Suture


Competitor


Greater straight tensile strength✓Greater knot tensile strength✓Less package memory✓



9.76 9.45



5.314.91



• 3-0 VICRYL Plus Suture displayed less

package memory than 3-0 Novosyn® Suture



17.70

23.87


Ethicon Sutures


References: 1. Tissue-holding comparisons, 100326296. May 26, 2015. Ethicon, Inc. 2. STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device,Instructions for Use. Ethicon, Inc. Somerville, NJ. 3. V-Loc™ 180 Absorbable Wound Closure Device, Instructions for Use, Medtronic. 56

Ethicon Suture

STRATAFIX™ Symmetric PDS™ Plus

Knotless Tissue Control Device

Competitor

Medtronic V-Loc™ 180 Absorbable

Wound Closure Device

Greater tissue-holding strength*

Greater extended tissue support

✓✓

• STRATAFIX Symmetric PDS Plus Device

displayed greater tissue-holding

strength than V-Loc™ 180 Device*

• STRATAFIX Symmetric PDS Plus Device

provides 6 weeks of tissue support while

V-Loc™ 180 Device provides support for

only 3 weeks

Testing Outcomes

*In porcine fascia

MEDTRONIC, V-Loc 180 Device

90.06

78.38ETHICON, STRATAFIX Symmetric PDS Plus Device

Days Implantation

% S

tre

ng

th R

ete

nti

on

90

80

70

60

50

7 14 21 28 35 42

ETHICON, STRATAFIX Symmetric PDS Plus Device

MEDTRONIC, V-Loc 180 Device

Tissue-Holding Strength (lbf)

Ethicon Sutures


References: 1. Report for Assessment 100552029. July 14, 2017. Ethicon, Inc. 2. Report for Assessment 100559286. July 19, 2017. Ethicon, Inc. 3. Performance Testing Report 100491281. November 17, 2016. 57

Ethicon Suture

STRATAFIX™ Spiral PDS™ Plus

Knotless Tissue Control Device

Competitor

Medtronic V-Loc™ 180 Absorbable

Wound Closure Device

Greater extended tissue support

Statistically equivalent tissue-holding strength

✓=

• STRATAFIX Spiral PDS Plus Device displayed greater extended tissue support than V-Loc™ 180 Device over a range of sizes

Testing Outcomes

Day 0 Day 28 In Vitro Day 42 In Vitro

100 100

55

81

1

50

% S

tre

ng

th R

ete

nti

on

MEDTRONIC, Size 0 V-Loc 180 Device

ETHICON, Size 0 STRATAFIXSpiral PDS Plus Device

MEDTRONIC, Size 2-0 V-Loc 180 Device

ETHICON, Size 2-0 STRATAFIXSpiral PDS Plus Device


100 100

72

88

3

45

% S

tre

ng

th R

ete

nti

on


100 100

86

95

17

60

% S

tre

ng

th R

ete

nti

on






100 100

7168

14

61

% S

tre

ng

th R

ete

nti

on

• STRATAFIX Spiral PDS Plus Device displayed

statistically equivalent tissue-holding strength

compared to V-Loc™ 180 Device over a range

of sizes

MEDTRONIC, 3-0 V-Loc 180 Device

50.961.4

ETHICON, 3-0 STRATAFIX Spiral PDS Plus Device



26.923.4

ETHICON, 4-0 STRATAFIX Spiral PDS Plus Device


Ethicon Sutures


References: 1. Report for Assessment 100559286. July 19, 2017. Ethicon, Inc. 2. Performance Testing Report 100491281. November 17, 2016.

58

Ethicon Suture

STRATAFIX™ Spiral PDS™ Plus Knotless

Tissue Control Device

Competitor

Ethicon PDS® Plus Antibacterial

(polydioxanone) Suture

Greater tissue-holding strength✓

• STRATAFIX Spiral PDS Plus Device displayed

greater tissue-holding strength than PDS Plus

Suture over a range of sizes

Testing Outcomes ETHICON, Size 1 PDS Plus Device

93.3

69.0 ETHICON, Size 1 STRATAFIX Spiral PDS Plus Device


ETHICON, 4-0 PDS Plus Device

26.9

15.9

ETHICON 4-0 STRATAFIX Spiral PDS Plus Device


• STRATAFIX Spiral MONOCRYL Plus Device displayed

statistically equivalent tissue-holding strength compared

to V-Loc™ 90 Device over a range of sizes

Testing Outcomes

Ethicon Suture

STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device

Competitor

Medtronic V-Loc™ 90 Absorbable Wound Closure Device

Statistically equivalent tissue-holding strength=

MEDTRONIC, 2-0 V-Loc 90 Device56.5

45.8

ETHICON, 2-0 STRATAFIX Spiral MONOCRYL Plus Device



22.0 18.6 ETHICON, 4-0 STRATAFIX Spiral MONOCRYL Plus Device


14.009.33

Ethicon Regional Sutures


Reference: Technical Report PE-2017-0028. September 22, 2017. Ethicon, Inc. 59

Ethicon Suture


Asia-Pacific Competitor

Alfresa 2-0 Nescosuture® Suture

Greater straight tensile strength✓Greater intrinsic straight tensile strength✓Greater knot security✓



tensile strength than 2-0

Nescosuture® Suture




2-0 Nescosuture® Suture

Testing Outcomes



ALFRESA, 2-0 Nescosuture

103.6

60.5




80

2






security compared to

2-0 Nescosuture® Suture

Suture Glossary

Straight Tensile Strength vs. Intrinsic Straight Tensile Strength

Straight tensile strength is a measure of the maximum load a suture

can resist before breaking. However, in a head-to-head matchup

when the diameter of one of the sutures exceeds the USP size listed

on the box—known as oversizing—this measurement alone does not

accurately describe which suture material is stronger. To correct for

oversizing, Ethicon Edge factors in suture diameter as well as

straight tensile strength to calculate intrinsic straight tensile strength.

When a particular matchup yields an advantage for the Ethicon

suture for intrinsic straight tensile strength, but not one for straight

tensile strength, the competitive suture may have been oversized.

Controlled Linear Elongation

Linear elongation is a key factor in how a suture handles and feels,

and refers to how much a suture stretches under tension. Ideally, a

suture should elongate to a point under tension to allow for wound

edema, but then return to its original length when edema subsides

to maintain the integrity of the closure. A suture that stretches more

and is able to return to its original length afterwards is said to exhibit

greater controlled linear elongation.

Knot Slide vs. Knot Security

Knot slide refers to a knot’s ability to slide down the suture during

tying, and it is essential to proper function. Ideally, the knot will slide

completely closed and then hold firm as pressure is applied to the

suture ends, eventually breaking at the knot. Failure of the knot to

slide properly may indicate a poorly constructed suture or an

inadequate coating.

The knot security test verifies that the knot will hold as pressure is

exerted on the ends of the suture. A passing knot exhibits no

movement or slippage before breaking, as indicated by a broken

suture with pigtails of equal length at the conclusion of the test.

60

Straight Tensile Strength

Controlled linear elongation

Knot Slide

Knot Security

ADVANCED MEDICAL SOLUTIONS, Skin Affix

10.13

3.54

ETHICON, DERMABOND ADVANCED Adhesive

Tensile Strength (lbf)

ADVANCED MEDICAL SOLUTIONS, Skin Affix

95


Drying Time (sec)

Ethicon Topical Skin Adhesives

Performance Testing

References: 1. Protocol Report 09PD070. January 15, 2010. Ethicon, Inc. 2. Performance Evaluation AST-2013-0548. September 30, 2014. Ethicon, Inc. 3. Technical Report 11TR053. August 16, 2011. Ethicon, Inc. 4. Performance Evaluation AST-2015-0256. August 13, 2015. Ethicon, Inc.

• In separate studies, DERMABOND ADVANCED

Adhesive displayed greater tensile strength (2-D)

than Skin Affix™1,2*


Adhesive displayed faster drying time than

Skin Affix™2,3†

Testing Outcomes

Ethicon Topical Skin Adhesive

DERMABOND ADVANCED® Topical Skin Adhesive

Competitor

Advanced Medical Solutions Skin Affix™ Topical Skin Adhesive

Faster drying time2,3†✓Greater tensile strength1,2*✓

171

MCKESSON, Liquiband Exceed

10.13

6.40


Tensile Strength (lbf)


Adhesive displayed greater tensile strength (2-D)

than Liquiband® Exceed™1,4‡

Testing Outcomes


DERMABOND ADVANCED® Topical Skin Adhesive

Competitor

McKesson Liquiband® Exceed™ Topical Skin Adhesive

Greater tensile strength1,4‡✓

61

*DERMABOND ADVANCED Adhesive value based on benchtop testing (09PD070) of porcine skin using the end-to-end skin tensile method RD-6-245 (N=50). Skin Affix™ value based on benchtop testing (AST-2013-0548) of porcine skin using end-to-end skin tensile method RD-6-245 (N=20).

†DERMABOND ADVANCED Adhesive value based on benchtop testing (11TR053) of porcine skin heated to 33ºC; product considered fully polymerized when no material transferred to cotton swab from any area of the application site (N=12). Skin Affix™ value based on benchtop testing (AST-2013-0548) of porcine skin heated to 33ºC; product considered set when no adhesive transferred to cotton swab (N=20).

‡DERMABOND ADVANCED Adhesive value based on benchtop testing (09PD070) of porcine skin using the end-to-end skin tensile method RD-6-245 (N=50). Liquiband® Exceed™ value based on benchtop testing (AST-2015-0256) of porcine skin using end-to-end skin tensile method RD-6-245 (N=23).


with subcuticular 4-0 MONOCRYL Sutures

20.59

13.92

9.30 ETHICON, DERMABOND PRINEO System


without subcuticular sutures

Tissue-Holding Strength (lbs)

Ethicon Topical Skin Adhesives


Reference: Performance Evaluation 100253930. September 4, 2014. Ethicon, Inc.62

• DERMABOND PRINEO System displayed

greater tissue-holding strength than DERMABOND

ADVANCED Adhesive with or without subcuticular

4-0 MONOCRYL® (poliglecaprone 25) Sutures

Testing Outcomes


DERMABOND® PRINEO® Skin Closure System (22 cm)

Competitor

ETHICON DERMABOND ADVANCED® Topical Skin Adhesive

with and without subcuticular sutures

Greater tissue-holding strength✓

MEDTRONIC, Endo Stitch with Surgidac

14.2812.96

ETHICON, PROXISURE with ETHIBOND

Knot Strength (lbf)

PENETRATION FORCE REQUIRED

MEDTRONIC, Endo Stitch Straight Needle

ETHICON, PROXISURE Curved Needle

GOOD

Pe

ne

tra

tio

n F

orc

e (

gra

ms)

Pass

1 35

56

173 168

85

Ethicon Advanced Suturing Systems


References: 1. Technical Memo CT16-001. May 11, 2016. Ethicon, Inc. 2. Engineering Study PRC073011. December 24, 2015. Ethicon, Inc.63

• PROXISURE Suturing Device’s curved

needle required 3x less penetration force

than the straight Endo Stitch™ needle1*

• PROXISURE Suturing Device with

ETHIBOND EXCEL Suture achieved

greater knot strength than Endo

Stitch™ with Surgidac™ suture2†

Testing Outcomes

Ethicon Advanced Suturing System

PROXISURE™ Suturing Device

with ETHIBOND EXCEL® Polyester Suture

Less penetration force required1*✓Greater knot strength2†✓

Competitor

Medtronic Endo Stitch™ Suturing Device with Surgidac™

Polyester Suture

†Size 2-0 sutures were tested using a benchtop method and equipment and material as described in test method DOC021468 (ETHIBOND N=19, Surgidac N=17).

*Needles tested through 35 passes in 0.4 mm Permair in accordance with TM406-080 (N=10). All measurements taken using an optical comparator or dial indicator.

360º coverage around catheter site✓

✓

Easier removal designed to lower the risk of catheter dislodgment

✓

64

Ethicon Vascular Access Device Protection

Competitive Performance TestingEthicon IV Protection

BIOPATCH® Protective Disk with CHG

Competitor

3M Tegaderm™ CHG Chlorhexidine Gluconate IV Securement Dressing

*BIOCLUSIVE is the securement dressing used with BIOPATCH Disk.References: 1. Westergom C, Mistry P, Bhende S, Aickin S. Comparative In Vitro/Ex Vivo Analysis of Two Catheter-Site Insertion Dressings. Presented at the Association for Vascular Access: September 11-14, 2008. Ethicon, Inc. 2. CDC Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011. 3. Approved claim 062483-161028. Ethicon, Inc. 4. Maki DG, Mermel LA, Kluger D, et al. The Efficacy of a Chlorhexidine-Impregnated Sponge (Biopatch) for the Prevention of Intravascular Catheter-Related Infection – A Prospective, Randomized, Controlled Multicenter Study. Abstracts of the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, September 2000, p. 422. 5. Ruschulte H, Franke M, Gastmeier P, et al. Prevention of central venous catheter related infections with chlorhexidine gluconate impregnated wound dressings: a randomized controlled trial. Ann Hematol. 2009;88:267-272. 6. Timsit JF, Schwebel C, Bouadma L, et al. Chlorhexidine-Impregnated Sponges and Less Frequent Dressing Changes for Prevention of Catheter-Related Infections in Critically Ill Adults. JAMA. 2009;301(12):1231-124. 7. Document BP-470-10-12/12. In Vitro Comparative Analysis of a Chlorhexidine Gluconate (CHG) Impregnated Sponge Dressing and a CHG-containing Hydrogel Dressing, 2010. Ethicon, Inc.

Only IV dressing with CHG proven in multiple randomized controlled trials (RCTs) to reduce incidence of catheter-related bloodstream infections (CRBSIs) in central venous and arterial catheters

• BIOPATCH Disk allows 360º delivery of CHG

around the catheter insertion site; Tegaderm™

CHG does not1

• BIOPATCH Disk is the only

IV dressing with CHG proven

in multiple RCTs to reduce

incidence of CRBSIs in central

venous and arterial catheters3

Testing Outcomes

• BIOPATCH Disk allows for easier

removal than Tegaderm™ CHG

which may lower the risk of

catheter dislodgment7

The density of skin flora at the catheter

insertion site is a major risk factor

for CRBSI2

3M, Tegaderm

ETHICON, BIOCLUSIVE*

3M, Tegaderm

0 5 73

Ne

wto

ns

16

12

8

4

0

Time (days)

FORCE REQUIRED TO REMOVE DRESSING

ETHICON, BIOPATCH

Maki, et al. 20004 687 BIOPATCH Disk significantly reduced the risk of life-threatening

CRBSI (1.2% in BIOPATCH group vs. 3.3% in control group, p=0.026)

Ruschulte, et al. 20095 601 BIOPATCH Disk significantly reduced CRBSI in immunocompromised

patients (6.3% in the BIOPATCH group vs. 11.3% in control group, p=0.016)

Study N Conclusion

Timsit, et al. 20096 1,636 Use of BIOPATCH Disk led to 69% decrease in CRBSI rate versus

non-chlorhexidine dressings (p=0.03)

Visuals depict CHG delivery zones for each product.

65

✓




Competitor

Medline Aegis™ CHG-Impregnated Foam Disc

• Unlike Aegis, BIOPATCH Disk

meets the updated CDC 1A

guideline as stated in the “2017

Updated Recommendations on

the Use of Chlorhexidine-Impregnated

Dressings for Prevention of

Intravascular Catheter-Related

Infections”

Testing Outcomes

ETHICON, BIOPATCH

MEDLINE, Aegis

7

6

5

4

3

2

1

0

BIOPATCH Disk is the only IV dressing with CHG proven in multiple randomized controlled trials (RCTs) to reduce incidence of catheter-related bloodstream infections (CRBSIs) in central venous and arterial catheters

✓BIOPATCH Disk meets the updated CDC 1A guideline as stated in the “2017 Updated Recommendations on the Use of Chlorhexidine-Impregnated Dressings for Prevention of Intravascular Catheter-Related Infections”

*Swab test resultsReferences: 1. Approved claim 062483-161028. Ethicon, Inc. 2. Maki DG, Mermel LA, Kluger D, et al. The Efficacy of a Chlorhexidine-Impregnated Sponge (Biopatch) for the Prevention of Intravascular Catheter-Related Infection – A Prospective, Randomized, Controlled Multicenter Study. Abstracts of the 40th Interscience Conference on Antimicrobial Agents and Chemothera-py, September 2000, p. 422. 3. Ruschulte H, Franke M, Gastmeier P, et al. Prevention of central venous catheter related infections with chlorhexidine gluconate impregnated wound dressings: a randomized controlled trial. Ann Hematol. 2009;88:267-272. 4. Timsit JF, Schwebel C, Bouadma L, et al. Chlorhexidine-Impregnated Sponges and Less Frequent Dressing Changes for Prevention of Catheter-Related Infections in Critically Ill Adults. JAMA. 2009;301(12):1231124. 5. BIOPATCH, Guardiva, Aegis. Study report for in vitro microbiological evaluation of Antimicrobial Barrier Dressings using zone of inhibition assay. June 28, 2016. Ethicon, Inc.

MRSA MRSE VRE P. aeruginosa A. baumanii K. pneumoniae C. albicans

DAYS WITH SUSTAINED MICROBICIDAL ACTIVITY UNDER THE DRESSING5*










Study N Conclusion



66



*Swab test resultsReferences: 1. Approved claim 062483-161028. Ethicon, Inc. 2. Maki DG, Mermel LA, Kluger D, et al. The Efficacy of a Chlorhexidine-Impregnated Sponge (Biopatch) for the Prevention of Intravascular Catheter-Related Infection – A Prospective, Randomized, Controlled Multicenter Study. Abstracts of the 40th Interscience Conference on Antimicrobial Agents and Chemothera-py, September 2000, p. 422. 3. Ruschulte H, Franke M, Gastmeier P, et al. Prevention of central venous catheter related infections with chlorhexidine gluconate impregnated wound dressings: a randomized controlled trial. Ann Hematol. 2009;88:267-272. 4. Timsit JF, Schwebel C, Bouadma L, et al. Chlorhexidine-Impregnated Sponges and Less Frequent Dressing Changes for Prevention of Catheter-Related Infections in Critically Ill Adults. JAMA. 2009;301(12):1231124. 5. BIOPATCH, Guardiva, Aegis. Study report for in vitro microbiological evaluation of Antimicrobial Barrier Dressings using zone of inhibition assay. June 28, 2016. Ethicon, Inc.

ETHICON, BIOPATCH

BARD, Guardiva

7

6

5

4

3

2

1

0


MRSA MRSE VRE P. aeruginosa A. baumanii K. pneumoniae C. albicans

Ethicon IV Protection


Competitor

Bard GuardIVa® Antimicrobial Hemostatic IV Dressing

Testing Outcomes






• Unlike GuardIVa®, BIOPATCH Disk







Infections”





Study N Conclusion



✓BIOPATCH Disk is the only IV dressing with CHG proven in multiple randomized controlled trials (RCTs) to reduce incidence of catheter-related bloodstream infections (CRBSIs) in central venous and arterial catheters


©2018 Ethicon US, LLC. All rights reserved. 063555-180509

67




Competitor

Medtronic Kendall™ AMD Antimicrobial Foam Disc Dressing

• Unlike Kendall™, BIOPATCH Disk







Infections”

*Swab test resultsReferences: 1. Approved claim 062483-161028. Ethicon, Inc. 2. Maki DG, Mermel LA, Kluger D, et al. The Efficacy of a Chlorhexidine-Impregnated Sponge (Biopatch) for the Prevention of Intravascular Catheter-Related Infection – A Prospective, Randomized, Controlled Multicenter Study. Abstracts of the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, September 2000, p. 422. 3. Ruschulte H, Franke M, Gastmeier P, et al. Prevention of central venous catheter related infections with chlorhexidine gluconate impregnated wound dressings: a randomized controlled trial. Ann Hematol. 2009;88:267-272. 4. Timsit JF, Schwebel C, Bouadma L, et al. Chlorhexidine-Impregnated Sponges and Less Frequent Dressing Changes for Prevention of Catheter-Related Infections in Critically Ill Adults. JAMA. 2009;301(12):1231124. 5. BIOPATCH-PHMB. Study report for in vitro microbiological evaluation of Antimicrobial Barrier Dressings using zone of inhibition assay. June 28, 2016. Ethicon, Inc.

ETHICON, BIOPATCH

MEDTRONIC, Kendall

7

6

5

4

3

2

1

0 MRSA MRSE VRE P. aeruginosa A. baumanii K. pneumoniae C. albicans


Testing Outcomes










Study N Conclusion



✓BIOPATCH Disk is the only IV dressing with CHG proven in multiple randomized controlled trials (RCTs) to reduce incidence of catheter-related bloodstream infections (CRBSIs) in central venous and arterial catheters


For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.

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