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Ethicon EdgeCompetitive PerformanceTesting
Wound Closure2018
The third-party trademarks used herein are trademarks of their respective owners.
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
• BV130-5 EVERPOINT (EVP)
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
ETHICON, BV130-5 (EVP)
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
ETHICON, BV130-5 (EVP)
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
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. 4
PENETRATION FORCE COMPARISON
STRENGTH COMPARISON
• BV130-5 EVERPOINT (EVP)
required less penetration
force than 2xDR6 from
1 to 30 passes
• BV130-5 EVERPOINT (EVP)
showed less variability
in penetration force than
2xDR6 from 1 to 30 passes
• BV130-5 EVERPOINT (EVP)
displayed greater (0-40º)
or statistically equivalent
(45-90º) strength
compared to 2xDR6
Testing Outcomes
Ethicon Needle Alloy Code
EVERPOINT (EVP) BV130-5
Competitor Code
B. Braun 2xDR6
PENETRATION FORCE STANDARD DEVIATION
Pe
ne
tra
tio
n F
orc
e (
gra
ms)
Pass
60
50
40
30
20
10
0
B. BRAUN, 2xDR6
ETHICON, BV130-5 (EVP)
1 10 20 30
GOOD
B. BRAUN, 2xDR6
ETHICON, BV130-5 (EVP)
GOOD
Sta
nd
ard
De
via
tio
n
Pass1 10 20 30
Less penetration force required
Less variability in penetration force
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
ETHICON, BV130-5 (EVP)
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
Ethicon Surgical Needles
Competitive Performance Testing
Reference: Technical Memo CT17-001. BV130-5 Competitive Assessment. February 10, 2017. Ethicon, Inc. 5
PENETRATION FORCE COMPARISON• BV130-5 required less
penetration force than
MV-135-5 from 1 to 30
passes
Testing Outcomes
Ethicon Needle Alloy Code
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✓
PENETRATION FORCE COMPARISON• BV130-5 required less
penetration force than
2xDR6 from 1 to 30 passes
Testing Outcomes
Ethicon Needle Alloy Code
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
Less penetration force required✓
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 CT16-001. BV175-6 Competitive Assessment. July 19, 2016. Ethicon, Inc. 6
STRENGTH COMPARISON
PENETRATION FORCE COMPARISON• BV175-6 EVERPOINT (EVP)
required less penetration
force than MV-175-8 from
1 to 30 passes
• BV175-6 EVERPOINT (EVP)
showed less variability
in penetration force than
MV-175-8 from 1 to 30
passes
• BV175-6 EVERPOINT (EVP)
displayed greater strength
than MV-175-8 regardless
of the angle at which force
was applied
Testing Outcomes
Ethicon Needle Alloy Code
EVERPOINT (EVP) BV175-6
Competitor Code
Medtronic MV-175-8
PENETRATION FORCE STANDARD DEVIATION
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)
MEDTRONIC, MV-175-8, 8 mil
ETHICON, BV175-6 (EVP), 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
MEDTRONIC, MV-175-8, 8 mil
ETHICON, BV175-6 (EVP), 8 milGOOD
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*
✓✓✓
2.5
4.9
8.57.6 7.4
2.3 2.2 2.2
Ethicon Surgical Needles
Competitive Performance Testing
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
MEDTRONIC, MV-175-8, 8 mil
ETHICON, BV175-6, 8 mil
1 10 20 30
• BV175-6 required less
penetration force than
MV-175-8 from 1 to 30
passes
• BV175-6 showed less
variability in penetration
force than MV-175-8 from
1 to 30 passes
Testing Outcomes
GOOD
PENETRATION FORCE COMPARISON
MEDTRONIC, MV-175-8, 8 mil
ETHICON, BV175-6, 8 mil
GOOD
Sta
nd
ard
De
via
tio
n
Pass
1 10 20 30
PENETRATION FORCE STANDARD DEVIATION
Ethicon Needle Alloy Code
ETHALLOY BV175-6
Competitor Code
Medtronic MV-175-8
Less penetration force required
Less variability in penetration force
✓✓
2.3
4.9
8.57.6 7.4
4.05.1
5.9
*Overall Strength, measured as Bend Moment, is a product of Surgical Yield, Ultimate Moment, Reshape, and Stiffness characteristics.
Reference: Technical Memo CT16-004. BV175-6 Competitive Assessment. August 23, 2016. Ethicon, Inc. 8
STRENGTH COMPARISON
• BV175-6 EVERPOINT (EVP)
showed less variability in
penetration force than
DR8f from 1 to 30 passes
• BV175-6 EVERPOINT (EVP)
displayed greater strength
than DR8f regardless of
the angle at which force
was applied
PENETRATION FORCE STANDARD DEVIATION
Be
nd
Mo
me
nt
(gra
m •
cm
)
Angle (degrees)
B. BRAUN, DR8f, 8 mil
ETHICON, BV175-6 (EVP), 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
B. BRAUN, DR8f, 8 mil
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
PENETRATION FORCE COMPARISON• BV175-6 EVERPOINT (EVP)
required less penetration
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
B. BRAUN, DR8f, 8 mil
ETHICON, BV175-6 (EVP), 8 mil
1 10 20 30
GOOD
Less penetration force required
Less variability in penetration force
Greater strength regardless of angle*
✓✓✓
Ethicon Surgical Needles
Competitive Performance TestingEthicon Needle Alloy Code
EVERPOINT (EVP) BV175-6
Reference: Technical Memo CT16-004. BV175-6 Competitive Assessment. August 23, 2016. Ethicon, Inc. 9
• BV175-6 showed less
variability in penetration
force than DR8f from 1 to
30 passes
PENETRATION FORCE STANDARD DEVIATION
B. BRAUN, DR8f, 8 mil
ETHICON, BV175-6, 8 mil
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
PENETRATION FORCE COMPARISON• BV175-6 required less
penetration 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
B. BRAUN, DR8f, 8 mil
ETHICON, BV175-6, 8 mil
1 10 20 30
GOOD
Less penetration force required
Less variability in penetration force
✓✓
Ethicon Surgical Needles
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
*Overall Strength, measured as Bend Moment, is a product of Surgical Yield, Ultimate Moment, Reshape, and Stiffness characteristics.
Reference: Technical Memo CT16-002. BV175-8 Competitive Assessment. July 19, 2016. Ethicon, Inc.
PENETRATION FORCE COMPARISON
Pe
ne
tra
tio
n F
orc
e (
gra
ms)
Pass
100
90
80
70
60
50
40
30
20
MEDTRONIC, MV-175-9, 8 mil
ETHICON, BV175-8 (EVP), 8 mil
1 10 20 30
• BV175-8 EVERPOINT (EVP)
required less penetration
force than MV-175-9 from
1 to 30 passes
• BV175-8 EVERPOINT (EVP)
showed less variability in
penetration force than
MV-175-9 from 1 to 30
passes
• BV175-8 EVERPOINT (EVP)
displayed greater strength
than MV-175-9 regardless
of the angle at which force
was applied
Testing Outcomes
GOOD
MEDTRONIC, MV-175-9, 8 mil
ETHICON, BV175-8 (EVP), 8 mil
MEDTRONIC, MV-175-9, 8 mil
ETHICON, BV175-8 (EVP), 8 mil
GOOD
Sta
nd
ard
De
via
tio
n
Pass1 10 20 30
PENETRATION FORCE STANDARD DEVIATION
Ethicon Needle Alloy Code
EVERPOINT (EVP) BV175-8
Competitor Code
Medtronic MV-175-9
Less penetration force required
Less variability in penetration force
Greater strength regardless of angle*
✓✓✓
Ethicon Surgical Needles
Competitive Performance Testing
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
Ethicon Needle Alloy Code
ETHALLOY C-1
Competitor Code
Medtronic CV-11
Greater or statistically equivalent strength*✓
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 CT17-006. C-1 Competitive Assessment. May 20, 2017. Ethicon, Inc.
12
PENETRATION FORCE COMPARISON
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
Ethicon Needle Alloy Code
ETHALLOY C-1
Competitor Code
B. Braun DR12
Less penetration force required✓Greater strength regardless of angle*✓
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 CT17-006. 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
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 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
in penetration force than
GS-24 from 1 to 30 passes
• CT displayed greater
strength than GS-24
regardless of the angle at
which force was applied
Testing Outcomes
Competitor Code
Medtronic GS-24
PENETRATION FORCE STANDARD DEVIATION
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
Less penetration force required
Less variability in penetration force
Greater strength regardless of angle*
✓✓✓
8.9
23.7
32.7 34.1 34.8
16.019.0
22.0
6.5
Ethicon Needle Alloy Code
Stainless Steel CT
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 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
in penetration force than
HR40s from 1 to 30 passes
• CT displayed greater
strength than HR40s
regardless of the angle at
which force was applied
Testing Outcomes
Competitor Code
B. Braun HR40s
PENETRATION FORCE STANDARD DEVIATION
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
Less penetration force required
Less variability in penetration force
Greater strength regardless of angle*
✓✓✓
8.910.5
19.020.1
22.3
16.019.0
22.0
Ethicon Needle Alloy Code
Stainless Steel CT
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 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
in penetration force than
GS-21 from 1 to 30 passes
• CT-1 displayed greater
strength than GS-21
regardless of the angle at
which force was applied
Testing Outcomes
Competitor Code
Medtronic GS-21
PENETRATION FORCE STANDARD DEVIATION
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
Less penetration force required
Less variability in penetration force
Greater strength regardless of angle*
✓✓✓
11.3
27.230.0
28.7 28.4
17.9 20.924.8
Ethicon Needle Alloy Code
Stainless Steel CT-1
Ethicon Surgical Needles
Competitive Performance Testing
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
Less penetration force required✓
Ethicon Needle Alloy Code
Stainless Steel CT-1
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 CT17-005. RB-1 Competitive Assessment. April 20, 2017. Ethicon, Inc. 17
STRENGTH COMPARISON• RB-1 displayed greater
strength than CV-23
regardless of the angle at
which force was applied
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*✓
Ethicon Needle Alloy Code
ETHALLOY RB-1
Ethicon Surgical Needles
Competitive Performance Testing
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
Less penetration force required
Greater strength regardless of angle*
✓✓
*Overall Strength, measured as Bend Moment, is a product of Surgical Yield, Ultimate Moment, Reshape, and Stiffness characteristics.
Reference: Technical Memo CT17-003. SH Needle Competitive Assessment. March 20, 2017. Ethicon, Inc.
Ethicon Needle Alloy Code
Stainless Steel SH
Ethicon Surgical Needles
Competitive Performance Testing
Reference: Technical Memo CT17-009. SH Competitive Assessment. September 26, 2017. Ethicon, Inc. 19
• SH showed less variability
in penetration force than
HR26 from 1 to 30 passes
Competitor Code
B. Braun HR26
Less penetration force required
Less variability in penetration force
✓✓
Ethicon Needle Alloy Code
Stainless Steel SH
• SH required less
penetration force than
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
PENETRATION FORCE STANDARD DEVIATION
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
Ethicon Surgical Needles
Competitive Performance Testing
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
Less penetration force required✓
Ethicon Needle Alloy Code
Stainless Steel V-7
• V-7 required less
penetration force than
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
Less penetration force required✓
• 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
Ethicon Needle Alloy Code
Stainless Steel V-34
PENETRATION FORCE COMPARISON
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
Competitive Performance Testing
*Overall Strength, measured as Bend Moment, is a product of Surgical Yield, Ultimate Moment, Reshape, and Stiffness characteristics.
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
Ethicon Needle Alloy Code
Stainless Steel CT-1
Ethicon Surgical Needles | STRATAFIX
Competitive Performance Testing
Reference: Technical Memo CT12-009. December 12, 2012. Ethicon, Inc.
Competitor Code
Medtronic V-Loc™ GS-25
Less penetration force required
Less variability in penetration force
✓✓
PENETRATION FORCE COMPARISON• STRATAFIX CTX required
less penetration force than
V-Loc™ GS-25 from 1 to
30 passes
• STRATAFIX CTX
showed less variability
in penetration force
than V-Loc™ GS-25 from
1 to 30 passes
Testing Outcomes
PENETRATION FORCE STANDARD DEVIATION
Pe
ne
tra
tio
n F
orc
e (
gra
ms)
Pass
ETHICON, STRATAFIX CTX, 50 mil
MEDTRONIC, V-Loc™ GS-25, 50 mil
1 10 20 30
GOOD
MEDTRONIC, V-Loc™ GS-25, 50 mil
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
Ethicon Needle Alloy Code
Stainless Steel CTX
Ethicon Surgical Needles | STRATAFIX
Competitive Performance Testing
Reference: Technical Memo CT12-009. December 12, 2012. Ethicon, Inc.
Competitor Code
Quill DE-14
Less penetration force required
Less variability in penetration force
✓✓
PENETRATION FORCE COMPARISON• STRATAFIX FS required
less penetration force than
Quill DE-14 from 1 to 30
passes
• STRATAFIX FS showed less
variability in penetration
force than Quill DE-14 from
1 to 30 passes
Testing Outcomes
PENETRATION FORCE STANDARD DEVIATION
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
QUILL, DE-14, 28 mil
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
Ethicon Needle Alloy Code
Stainless Steel FS
Ethicon Surgical Needles | STRATAFIX
Competitive Performance Testing
*Overall Strength, measured as Bend Moment, is a product of Surgical Yield, Ultimate Moment, Reshape, and Stiffness characteristics.
Reference: Technical Memo CT09-022. January 20, 2010. Ethicon, Inc.
STRENGTH COMPARISON
PENETRATION FORCE COMPARISON• STRATAFIX FS-2
required less penetration
force than Quill DE-12
from 1 to 30 passes
• STRATAFIX FS-2
showed less variability
in penetration force
than Quill DE-12 from
1 to 30 passes
• STRATAFIX FS-2
displayed greater strength
than Quill DE-12 regardless
of the angle at which force
was applied
Testing Outcomes
Competitor Code
Quill DE-12
PENETRATION FORCE STANDARD DEVIATION
Pe
ne
tra
tio
n F
orc
e (
gra
ms)
Pass
160
140
120
100
80
60
40
20
0
QUILL, DE-12, 22 mil
ETHICON, STRATAFIX FS-2, 24 mil
1 10 20 30
GOOD
To
rqu
e (g
ram
• c
m)
Angle (degrees)
QUILL, DE-12, 22 mil
ETHICON, STRATAFIX FS-2, 24 mil
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
QUILL, DE-12, 22 mil
ETHICON, STRATAFIX FS-2, 24 mil
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*
✓✓✓
8.0
13.5
11.0 11.4 10.7
5.4
7.68.3
Ethicon Needle Alloy Code
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
Competitive Performance Testing
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
ETHICON, 2-0 ETHIBOND
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
ETHICON, 2-0 ETHIBOND
MEDTRONIC, 2-0 Ti-Cron
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
MEDTRONIC, 2-0 Ti-Cron
80
72
Ethicon Suture
2-0 ETHIBOND EXCEL® Polyester Suture
Ethicon Sutures
Competitive Performance Testing
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
2-0 ETHIBOND EXCEL® Polyester Suture
Competitor
B. Braun 2-0 PremiCron® Suture
Greater straight tensile strength✓
Greater intrinsic straight tensile strength✓
Less package memory✓
Greater controlled linear elongation✓
More reliable knot slide✓
ETHICON, 2-0 ETHIBOND
B. BRAUN, 2-0 Premicron
14.0012.40
Straight Tensile Strength (lbs)
• 2-0 ETHIBOND EXCEL Suture displayed less package
memory than 2-0 PremiCron® Suture
ETHICON, 2-0 ETHIBOND
B. BRAUN, 2-0 Premicron
6.87
13.63
Package Memory - Short Pack (%)
• 2-0 ETHIBOND EXCEL Suture displayed greater intrinsic
straight tensile strength than 2-0 PremiCron® Suture
ETHICON, 2-0 ETHIBOND
B. BRAUN, 2-0 Premicron
103.6
94.7
Intrinsic Straight Tensile Strength (kpsi)
Controlled Linear Elongation (%)
• 2-0 ETHIBOND EXCEL Suture displayed greater
controlled linear elongation than 2-0 PremiCron® Suture
ETHICON, 2-0 ETHIBOND
B. BRAUN, 2-0 Premicron
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
B. BRAUN, 2-0 Premicron
100
67
Reference: Technical Report PE-2017-0023. October 2, 2017. Ethicon, Inc. 28
Ethicon Sutures
Competitive Performance TestingEthicon Suture
4-0 ETHIBOND EXCEL® Polyester Suture
Competitor
Medtronic 4-0 Ti-Cron™ Suture
Less package memory✓
• 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, 4-0 ETHIBOND
MEDTRONIC, 4-0 Ti-Cron
✓
Reference: Technical Report PE-2017-0023. October 2, 2017. Ethicon, Inc. 29
Ethicon Sutures
Competitive Performance Testing
119.91 115.86
Intrinsic Straight Tensile Strength (kpsi)
Ethicon Suture
4-0 ETHIBOND EXCEL® Polyester Suture
Competitor
B. Braun 4-0 PremiCron® Suture
Greater intrinsic straight tensile strength✓Less package memory✓Greater controlled linear elongation✓More reliable knot slide✓
• 4-0 ETHIBOND EXCEL Suture
displayed greater intrinsic
straight tensile strength than
4-0 PremiCron® Suture
Testing Outcomes ETHICON, 4-0 ETHIBOND
B. BRAUN, 4-0 Premicron
5.30
10.57
10.96 10.09
Package Memory – Short Pack (%)
Controlled Linear Elongation (%)
• 4-0 ETHIBOND EXCEL Suture
displayed less package memory
than 4-0 PremiCron® Suture
• 4-0 ETHIBOND EXCEL Suture
displayed greater controlled
linear elongation than 4-0
PremiCron® Suture
ETHICON, 4-0 ETHIBOND
B. BRAUN, 4-0 Premicron
ETHICON, 4-0 ETHIBOND
B. BRAUN, 4-0 Premicron
10087
Knot Slide Occurrences (%)
• 4-0 ETHIBOND EXCEL Suture
displayed more reliable knot
slide compared to 4-0
PremiCron® Suture
ETHICON, 4-0 ETHIBOND
B. BRAUN, 4-0 Premicron
4.763.00
136.46
87.55
• 5-0 MONOCRYL Suture displayed
greater straight tensile strength
than 5-0 Caprosyn™ Suture
• 5-0 MONOCRYL Suture displayed
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
ETHICON, 5-0 MONOCRYL
MEDTRONIC, 5-0 Caprosyn
Straight Tensile Strength (lbs)
Intrinsic Straight Tensile Strength (kpsi)
Reference: Technical Report PE-2017-0031. October 2, 2017. Ethicon, Inc.
Ethicon Sutures
Competitive Performance Testing
30
Ethicon Suture
5-0 MONOCRYL® (poliglecaprone 25) Suture
Competitor
Medtronic 5-0 Caprosyn™ Suture
Less package memory✓
More reliable knot slide✓
11.90
51.37
2.25 1.80
• 5-0 MONOCRYL Suture displayed
greater knot tensile strength than
5-0 Caprosyn™ Suture
ETHICON, 5-0 MONOCRYL
MEDTRONIC, 5-0 Caprosyn
Knot Tensile Strength (lbs)
• 5-0 MONOCRYL Suture
displayed less package memory
than 5-0 Caprosyn™ Suture
ETHICON, 5-0 MONOCRYL
MEDTRONIC, 5-0 Caprosyn
Package Memory - Short Pack (%)
100
83• 5-0 MONOCRYL Suture
displayed more reliable
knot slide compared to
5-0 Caprosyn™ Suture
ETHICON, 5-0 MONOCRYL
MEDTRONIC, 5-0 Caprosyn
Knot Slide Occurrences (%)
4.763.71
• 5-0 MONOCRYL Suture displayed
greater straight tensile strength
than 5-0 Monosyn® Suture
• 5-0 MONOCRYL Suture
displayed greater intrinsic
straight tensile strength than
5-0 Monosyn® Suture
Testing Outcomes
Greater straight tensile strength✓Greater intrinsic straight tensile strength✓Less package memory ✓
ETHICON, 5-0 MONOCRYL
B. BRAUN, 5-0 Monosyn
ETHICON, 5-0 MONOCRYL
B. BRAUN, 5-0 Monosyn
136.46
91.80
Straight Tensile Strength (lbs)
Intrinsic Straight Tensile Strength (kpsi)
Reference: Technical Report PE-2017-0031. October 2, 2017. Ethicon, Inc. 31
Ethicon Sutures
Competitive Performance TestingEthicon Suture
5-0 MONOCRYL® (poliglecaprone 25) Suture
Competitor
B. Braun 5-0 Monosyn® Suture
• 5-0 MONOCRYL Suture
displayed less package memory
than 5-0 Monosyn® Suture
ETHICON, 5-0 MONOCRYL
B. BRAUN, 5-0 Monosyn
11.90
39.07
Package Memory – Short Pack (%)
Ethicon Sutures
Competitive Performance Testing
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)
Less package memory✓
Greater controlled linear elongation✓
ETHICON, 5-0 PROLENE
B. BRAUN, 5-0 Optilene
40.3
47.0
ETHICON, 5-0 PROLENE
B. BRAUN, 5-0 Optilene
35.231.6
Package Memory - Short Pack (%)
Controlled Linear Elongation (%)
• 5-0 PROLENE Suture displayed greater controlled linear
elongation than 5-0 Surgipro™ II Suture
Testing Outcomes
Ethicon Suture
5-0 PROLENE® Polypropylene Suture
Competitor
Medtronic 5-0 Surgipro™ II Polypropylene Monofilament Suture
Greater controlled linear elongation✓
ETHICON, 5-0 PROLENE
MEDTRONIC 5-0 Surgipro II
35.230.7
Package Memory - Short Pack (%)
Ethicon Sutures
Competitive Performance Testing
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
5-0 PROLENE® Polypropylene Suture
Competitor
B. Braun 5-0 Premilene® Suture (Non-Absorbable)
ETHICON, 5-0 PROLENE
B. BRAUN, 5-0 Premilene
2.21 1.86
Straight Tensile Strength (lbs)
Greater straight tensile strength✓
Greater knot tensile strength✓Greater intrinsic straight tensile strength✓
Less package memory✓
• 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
B. BRAUN, 5-0 Premilene
84.672.7
Intrinsic Straight Tensile Strength (kpsi)
Package Memory - Short Pack (%)
• 5-0 PROLENE Suture displayed less package memory
than 5-0 Premilene® Suture
ETHICON, 5-0 PROLENE
B. BRAUN, 5-0 Premilene 40.3 43.4
Ethicon Sutures
Competitive Performance Testing
Reference: Technical Report PE-2016-0020. October 19, 2016. Ethicon, Inc.34
• 6-0 PROLENE Suture displayed less package memory
than 6-0 Optilene™ Non-Absorbable Suture
• 6-0 PROLENE Suture displayed greater controlled linear
elongation than 6-0 Optilene™ Non-Absorbable Suture
Testing Outcomes
Ethicon Suture
6-0 PROLENE® Polypropylene Suture
Competitor
B. Braun 6-0 Optilene™ Non-Absorbable Suture
ETHICON, 6-0 PROLENE
B. BRAUN, 6-0 Optilene25.2
37.6
Package Memory – Short Pack (%)
ETHICON, 6-0 PROLENE
B. BRAUN, 6-0 Optilene
36.2
28.9
Controlled Linear Elongation (%)
Less package memory
Greater controlled linear elongation
✓✓
• 6-0 PROLENE Suture displayed greater controlled linear
elongation than 6-0 Surgipro™ II Suture
Testing Outcomes
Ethicon Suture
6-0 PROLENE® Polypropylene Suture
Competitor
Medtronic 6-0 Surgipro™ II Polypropylene Monofilament Suture
Greater controlled linear elongation✓
ETHICON, 6-0 PROLENE
MEDTRONIC, 6-0 Surgipro II
36.231.8
Controlled Linear Elongation (%)
Ethicon Sutures
Competitive Performance Testing
Reference: Technical Report PE-2016-0020. October 19, 2016. Ethicon, Inc. 35
Ethicon Suture
6-0 PROLENE® Polypropylene Suture
Competitor
B. Braun 6-0 Premilene® Suture (Non-Absorbable)
• 6-0 PROLENE Suture displayed greater straight tensile
strength than 6-0 Premilene® Suture
Testing OutcomesETHICON, 6-0 PROLENE
B. BRAUN, 6-0 Premilene
1.060.79
• 6-0 PROLENE Suture displayed greater knot tensile
strength than 6-0 Premilene® Suture
ETHICON, 6-0 PROLENE
B. BRAUN, 6-0 Premilene
0.86 0.78
• 6-0 PROLENE Suture displayed less package memory
than 6-0 Premilene® Suture
Greater straight tensile strength✓
Greater knot tensile strength✓Greater intrinsic straight tensile strength✓
Greater controlled linear elongation✓Less package memory ✓
Straight Tensile Strength (lbs)
Knot Tensile Strength (lbs)
• 6-0 PROLENE Suture displayed greater intrinsic straight
tensile strength than 6-0 Premilene® Suture
ETHICON, 6-0 PROLENE
B. BRAUN, 6-0 Premilene
86.270.7
Intrinsic Straight Tensile Strength (kpsi)
ETHICON, 6-0 PROLENE
B. BRAUN, 6-0 Premilene25.234.1
Package Memory – Short Pack (%)
• 6-0 PROLENE Suture displayed greater controlled linear
elongation than 6-0 Premilene® SutureETHICON, 6-0 PROLENE
B. BRAUN, 6-0 Premilene
36.2
26.7
Controlled Linear Elongation (%)
Ethicon Sutures
Competitive Performance Testing
Reference: Technical Report PE-2016-0020. November 8, 2016. Ethicon, Inc.36
• 7-0 PROLENE Suture displayed greater straight tensile
strength than 7-0 Premilene® Suture
• 7-0 PROLENE Suture displayed greater knot tensile
strength than 7-0 Premilene® Suture
Testing Outcomes
Ethicon Suture
7-0 PROLENE® Polypropylene Suture
Competitor
B. Braun 7-0 Premilene® Suture (Non-Absorbable)
Greater straight tensile strength✓
Greater knot tensile strength✓Greater intrinsic straight tensile strength✓
Less package memory✓Greater controlled linear elongation✓
ETHICON, 7-0 PROLENE
B. BRAUN, 7-0 Premilene
0.620.46
ETHICON, 7-0 PROLENE
B. BRAUN, 7-0 Premilene0.50 0.44
• 7-0 PROLENE Suture displayed less package memory
than 7-0 Premilene® Suture
ETHICON, 7-0 PROLENE
B. BRAUN, 7-0 Premilene7.5
9.7
• 7-0 PROLENE Suture displayed greater controlled linear
elongation than 7-0 Premilene® Suture
Straight Tensile Strength (lbs)
Knot Tensile Strength (lbs)
Package Memory - Short Pack (%)
• 7-0 PROLENE Suture displayed greater intrinsic straight
tensile strength than 7-0 Premilene® Suture
ETHICON, 7-0 PROLENE
B. BRAUN, 7-0 Premilene
99.881.6
Intrinsic Straight Tensile Strength (kpsi)
ETHICON, 7-0 PROLENE
B. BRAUN, 7-0 Premilene
29.325.2
Controlled Linear Elongation (%)
Ethicon Sutures
Competitive Performance Testing
Reference: Technical Report PE-2016-0020. February 1, 2017. Ethicon, Inc.37
• 8-0 PROLENE Suture displayed greater straight tensile
strength than 8-0 Premilene® Suture
• 8-0 PROLENE Suture displayed greater intrinsic straight
tensile strength than 8-0 Premilene® Suture
Testing Outcomes
Ethicon Suture
8-0 PROLENE® Polypropylene Suture
Competitor
B. Braun 8-0 Premilene® Suture (Non-Absorbable)
ETHICON, 8-0 PROLENE
B. BRAUN, 8-0 Premilene
132.9123.6
ETHICON, 8-0 PROLENE
B. BRAUN, 8-0 Premilene
122.489.3
Straight Tensile Strength (gram-force)
Intrinsic Straight Tensile Strength (kpsi)
• 8-0 PROLENE Suture displayed greater knot tensile
strength than 8-0 Premilene® SutureETHICON, 8-0 PROLENE
B. BRAUN, 8-0 Premilene
107.7 101.6
Knot Tensile Strength (gram-force)
Greater straight tensile strength✓Greater intrinsic straight tensile strength✓Greater knot tensile strength✓
Ethicon Sutures
Competitive Performance Testing
Reference: Technical Report PE-2016-0020. February 1, 2017. Ethicon, Inc.38
• 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
B. BRAUN, 8-0 Optilene
217.5161.1
ETHICON, 8-0 OS PROLENE
B. BRAUN, 8-0 Optilene
167.4112.9
Straight Tensile Strength (gram-force)
Knot Tensile Strength (gram-force)
• 8-0 OS PROLENE Suture displayed greater controlled
linear elongation than 8-0 Optilene™ SutureETHICON, 8-0 OS PROLENE
B. BRAUN, 8-0 Optilene
35.6824.42
Controlled Linear Elongation (%)
Greater straight tensile strength✓Greater knot tensile strength✓Greater controlled linear elongation✓
Ethicon Sutures
Competitive Performance Testing
Reference: Technical Report PE-2016-0020. February 1, 2017. Ethicon, Inc.39
• 8-0 OS PROLENE Suture displayed greater straight tensile
strength than 8-0 Premilene® Suture
• 8-0 OS PROLENE Suture displayed greater intrinsic
straight tensile strength than 8-0 Premilene® Suture
Testing Outcomes
Ethicon Suture
8-0 Oversized (OS) PROLENE® Polypropylene Suture
Competitor
B. Braun 8-0 Premilene® Suture (Non-Absorbable)
Greater straight tensile strength✓
Greater intrinsic straight tensile strength✓
Greater knot tensile strength✓
ETHICON, 8-0 OS PROLENE
B. BRAUN, 8-0 Premilene
217.5
123.6
ETHICON, 8-0 OS PROLENE
B. BRAUN, 8-0 Premilene
109.289.3
Straight Tensile Strength (gram-force)
Intrinsic Straight Tensile Strength (kpsi)
• 8-0 OS PROLENE Suture displayed greater knot
strength than 8-0 Premilene® Suture
ETHICON, 8-0 OS PROLENE
B. BRAUN, 8-0 Premilene
167.4
101.6
Knot Tensile Strength (gram-force)
Ethicon Sutures
Competitive Performance Testing
Reference: Technical Report PE-2016-0020. February 1, 2017. Ethicon, Inc.40
Greater straight tensile strength✓
Greater intrinsic straight tensile strength✓
Greater knot tensile strength✓
• 8-0 OS PROLENE Suture displayed greater straight tensile
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
8-0 Oversized (OS) PROLENE® Polypropylene Suture
Competitor
Medtronic 8-0 Surgipro™ II Polypropylene Monofilament Suture
ETHICON, 8-0 OS PROLENE
MEDTRONIC, 8-0 Surgipro II
217.5
173.8
ETHICON, 8-0 OS PROLENE
MEDTRONIC, 8-0 Surgipro II109.2 104.0
Straight Tensile Strength (gram-force)
Intrinsic Straight Tensile Strength (kpsi)
• 8-0 OS PROLENE Suture displayed greater knot tensile
strength than 8-0 Surgipro™ II Suture
ETHICON, 8-0 OS PROLENE
MEDTRONIC, 8-0 Surgipro II
167.4134.8
Knot Tensile Strength (gram-force)
• Size 1 VICRYL Suture
displayed greater straight
tensile strength than
size 1 Novosyn® Suture
• Size 1 VICRYL Suture
displayed greater knot
tensile strength than
size 1 Novosyn® Suture
Testing Outcomes
Greater straight tensile strength✓
Greater knot tensile strength✓Greater intrinsic straight tensile strength✓
Less package memory✓
ETHICON, Size 1 VICRYL
B. BRAUN, Size 1 Novosyn
28.74 27.61
ETHICON, Size 1 VICRYL
B. BRAUN, Size 1 Novosyn
15.39 13.91
Straight Tensile Strength (lbs)
Knot Tensile Strength (lbs)
• Size 1 VICRYL Suture
displayed greater intrinsic
straight tensile strength
than size 1 Novosyn® Suture
ETHICON, Size 1 VICRYL
B. BRAUN, Size 1 Novosyn
94.9
84.5
Intrinsic Straight Tensile Strength (kpsi)
• Size 1 VICRYL Suture
displayed less package
memory than size 1
Novosyn® Suture
ETHICON, Size 1 VICRYL
B. BRAUN, Size 1 Novosyn
19.87
30.87
Package Memory - Short Pack (%)
Reference: Technical Report PE-2017-0019. September 25, 2017. Ethicon, Inc.
Ethicon Sutures
Competitive Performance Testing
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
B. BRAUN, Size 1 Novosyn
Reference: Technical Report PE-2017-0019. September 25, 2017. Ethicon, Inc. 42
Ethicon Sutures
Competitive Performance TestingEthicon Suture
Size 1 Coated VICRYL® Plus Antibacterial
(polyglactin 910) Suture
Competitor
B. Braun Size 1 Novosyn® Suture
• Size 1 VICRYL Plus Suture
displayed greater straight
tensile strength than
size 1 Novosyn® Suture
• Size 1 VICRYL Plus Suture
displayed greater intrinsic
straight tensile strength than
size 1 Novosyn® Suture
Testing Outcomes
Greater straight tensile strength✓Greater intrinsic straight tensile strength✓
Greater knot tensile strength ✓
ETHICON, Size 1 VICRYL Plus
B. BRAUN, Size 1 Novosyn
Straight Tensile Strength (lbs)
Intrinsic Straight Tensile Strength (kpsi)
88.084.5
ETHICON, Size 1 VICRYL Plus
B. BRAUN, Size 1 Novosyn
• Size 1 VICRYL Plus Suture
displayed greater knot
tensile strength than
size 1 Novosyn® Suture
Knot Tensile Strength (lbs)
15.13 13.91
• Size 1 VICRYL Suture displayed
greater intrinsic straight tensile
strength than size 1 MITSU AB™
Suture
• Size 1 VICRYL 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✓
ETHICON, Size 1 VICRYL
MERIL, Size 1 MITSU AB
ETHICON, Size 1 VICRYL
MERIL, Size 1 MITSU AB
94.989.4
Intrinsic Straight Tensile Strength (kpsi)
• Size 1 VICRYL Suture
displayed greater controlled
linear elongation than size 1
MITSU AB™ Suture
ETHICON, Size 1 VICRYL
MERIL, Size 1 MITSU AB
23.7
18.0
Controlled Linear Elongation (%)
ETHICON, Size 1 VICRYL
MERIL, Size 1 MITSU AB
97
0
Knot Slide Occurrences (%)
• Size 1 VICRYL Suture
displayed more reliable
knot slide compared to
size 1 MITSU AB™ Suture
Reference: Technical Report PE-2017-0039. April 17, 2018. Ethicon, Inc.
Ethicon Sutures
Competitive Performance Testing
43
Ethicon Suture
Size 1 Coated VICRYL® (polyglactin 910) 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)
• Size 1 VICRYL Plus Suture
displayed greater in vivo
breaking strength retention
(BSR) at 14, 21, and 28 days
compared to size 1 MITSU
AB™ Suture
• Size 1 VICRYL Plus Suture
displayed greater controlled
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 VICRYL Plus Suture
displayed more reliable
knot slide compared to
size 1 MITSU AB™ Suture
Reference: Technical Report PE-2017-0039. April 17, 2018. Ethicon, Inc.
Ethicon Sutures
Competitive Performance Testing
44
Ethicon Suture
Size 1 Coated VICRYL® Plus Antibacterial
(polyglactin 910) Suture
Competitor
Meril Size 1 MITSU AB™ Suture
ETHICON, Size 1 VICRYL Plus
MERIL, Size 1 MITSU AB
14 Days 21 Days 28 Days
20.615.7
9.9
14.6
0.05.2
In Vivo BSR Load (lbs)
ETHICON, Size 1 VICRYL Plus
MERIL, Size 1 MITSU AB
100
0
Knot Slide Occurrences (%)
ETHICON, Size 1 VICRYL Plus
MERIL, Size 1 MITSU AB23.918.0
Controlled Linear Elongation (%)
Ethicon Sutures
Competitive Performance Testing
Reference: Technical Report PE-2016-0025. February 28, 2017. Ethicon, Inc.45
• Size 0 VICRYL Suture displayed greater
intrinsic straight tensile strength than
size 0 Polysorb™ Suture
Testing Outcomes
Ethicon Suture
Size 0 Coated VICRYL® (polyglactin 910) Suture
Competitor
Medtronic Size 0 Polysorb™ Suture
Greater intrinsic straight tensile strength✓Less package memory✓More reliable knot slide✓
ETHICON, Size 0 VICRYL
MEDTRONIC, Size 0 Polysorb
109.8102.7
Intrinsic Straight Tensile Strength (kpsi)
• Size 0 VICRYL Suture displayed
less package memory than
size 0 Polysorb™ Suture
ETHICON, Size 0 VICRYL
MEDTRONIC, Size 0 Polysorb 11.80
18.93
Package Memory - Short Pack (%)
• Size 0 VICRYL Suture displayed
more reliable knot slide compared
to size 0 Polysorb™ SutureETHICON, Size 0 VICRYL
MEDTRONIC, Size 0 Polysorb
100
53
Knot Slide Occurrences (%)
Ethicon Sutures
Competitive Performance Testing
Reference: Technical Report PE-2016-0025. February 28, 2017. Ethicon, Inc.46
• Size 0 VICRYL Suture displayed greater intrinsic straight
tensile strength than size 0 Novosyn® Suture
Testing Outcomes
Ethicon Suture
Size 0 Coated VICRYL® (polyglactin 910) Suture
Competitor
B. Braun Size 0 Novosyn® Suture
Greater knot tensile strength✓Less package memory✓
Greater intrinsic straight tensile strength✓
Greater knot security✓
ETHICON, Size 0 VICRYL
B. BRAUN, Size 0 Novosyn
109.8103.0
Intrinsic Straight Tensile Strength (kpsi)
• 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
Knot Tensile Strength (lbs)
• Size 0 VICRYL Suture displayed less package memory
than size 0 Novosyn® Suture
ETHICON, Size 0 VICRYL
B. BRAUN, Size 0 Novosyn
11.80
28.80
Package Memory - Short Pack (%)
• Size 0 VICRYL Suture displayed greater knot security
compared to size 0 Novosyn® Suture
ETHICON, Size 0 VICRYL
B. BRAUN, Size 0 Novosyn
8273
Knot Security Occurrences (%)
Ethicon Sutures
Competitive Performance Testing
Reference: Technical Report PE-2016-0025. February 28, 2017. Ethicon, Inc.47
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
ETHICON, Size 0 VICRYL Plus
MEDTRONIC, Size 0 Polysorb53
Knot Slide Occurrences (%)
• 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
ETHICON, Size 0 VICRYL Plus
MEDTRONIC, Size 0 Polysorb
107.3 102.7
Intrinsic Straight Tensile Strength (kpsi)
100
Ethicon Sutures
Competitive Performance Testing
Reference: Technical Report PE-2016-0025. February 28, 2017. Ethicon, Inc.48
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
B. BRAUN, Size 0 Novosyn
107.3 103.0
Intrinsic Straight Tensile Strength (kpsi)
• 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
Knot Tensile Strength (lbs)
• 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
B. Braun Size 0 Novosyn® Suture
ETHICON, Size 0 VICRYL Plus
B. BRAUN, Size 0 Novosyn
23.22 22.32
Straight Tensile Strength (lbs)
Ethicon Sutures
Competitive Performance Testing
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
Package Memory - Short Pack (%)
• 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
Intrinsic Straight Tensile Strength (kpsi)
• 2-0 VICRYL Suture displayed more reliable knot
slide compared to 2-0 Polysorb™ SutureETHICON, 2-0 VICRYL
MEDTRONIC, 2-0 Polysorb
100
63
Knot Slide Occurrences (%)
Ethicon Sutures
Competitive Performance Testing
Reference: Technical Report PE-2016-0025. December 15, 2016. Ethicon, Inc.50
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
Medtronic 2-0 Polysorb™ Suture
Less package memory✓More reliable knot slide✓
ETHICON, 2-0 VICRYL Plus
MEDTRONIC, 2-0 Polysorb16.3324.20
Package Memory - Short Pack (%)
• 2-0 VICRYL Plus Suture displayed more reliable
knot slide compared to 2-0 Polysorb™ SutureETHICON, 2-0 VICRYL Plus
MEDTRONIC, 2-0 Polysorb
100
63
Knot Slide Occurrences (%)
Ethicon Sutures
Competitive Performance Testing
Reference: Technical Report PE-2016-0025. December 15, 2016. Ethicon, Inc.51
• 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
2-0 Coated VICRYL® (polyglactin 910) 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
B. BRAUN, 2-0 Novosyn
125.3 120.4
Straight Tensile Strength (lbs)
Intrinsic Straight Tensile Strength (kpsi)
• 2-0 VICRYL Suture displayed less package memory than
2-0 Novosyn® Suture
ETHICON, 2-0 VICRYL
B. BRAUN, 2-0 Novosyn
14.00
25.10
Package Memory - Short Pack (%)
• 2-0 VICRYL Suture displayed greater knot security
compared to 2-0 Novosyn® SutureETHICON, 2-0 VICRYL
B. BRAUN, 2-0 Novosyn
92
72
Knot Security Occurrences (%)
Ethicon Sutures
Competitive Performance Testing
Reference: Technical Report PE-2016-0025. December 15, 2016. Ethicon, Inc.52
• 2-0 VICRYL Plus Suture displayed less package memory
than 2-0 Novosyn® Suture
Testing Outcomes
Ethicon Suture
2-0 Coated VICRYL® Plus Antibacterial (polyglactin 910) Suture
Competitor
B. Braun 2-0 Novosyn® Suture
Less package memory✓Greater knot security✓
ETHICON, 2-0 VICRYL Plus
B. BRAUN, 2-0 Novosyn
16.33
25.10
Package Memory - Short Pack (%)
ETHICON, 2-0 VICRYL Plus
B. BRAUN, 2-0 Novosyn
87
72
Knot Security Occurrences (%)
• 2-0 VICRYL Plus Suture displayed greater knot security
compared to 2-0 Novosyn® Suture
Ethicon Sutures
Competitive Performance Testing
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
3-0 Coated VICRYL® (polyglactin 910) Suture
Competitor
Medtronic 3-0 Polysorb™ Suture
Less package memory✓More reliable knot slide✓
ETHICON, 3-0 VICRYL
MEDTRONIC, 3-0 Polysorb
12.17
22.03
Package Memory - Short Pack (%)
• 3-0 VICRYL Plus Suture displayed less package
memory than 3-0 Polysorb™ Suture
Testing Outcomes
Ethicon Suture
3-0 Coated VICRYL® Plus Antibacterial (polyglactin 910) Suture
Competitor
Medtronic 3-0 Polysorb™ Suture
Less package memory✓Superior knot slide characteristics✓
ETHICON, 3-0 VICRYL Plus
MEDTRONIC, 3-0 Polysorb
17.70
22.03
Package Memory - Short Pack (%)
ETHICON, 3-0 VICRYL
MEDTRONIC, 3-0 Polysorb
100
66
Knot Security Occurrences (%)
Knot Security Occurrences (%)
• 3-0 VICRYL Suture displayed more reliable
knot slide compared to 3-0 Polysorb™ Suture
ETHICON, 3-0 VICRYL Plus
MEDTRONIC, 3-0 Polysorb
100
66
• 3-0 VICRYL Plus Suture displayed more reliable
knot slide compared to 3-0 Polysorb™ Suture
Ethicon Sutures
Competitive Performance Testing
Reference: Technical Report PE-2016-0025. January 11, 2017. Ethicon, Inc.54
• 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
3-0 Coated VICRYL® (polyglactin 910) Suture
Competitor
B. Braun 3-0 Novosyn® Suture
Greater straight tensile strength✓Greater intrinsic straight tensile strength✓Greater knot tensile strength✓Less package memory✓
ETHICON, 3-0 VICRYL
B. BRAUN, 3-0 Novosyn
10.01 9.45
ETHICON, 3-0 VICRYL
B. BRAUN, 3-0 Novosyn
5.24 4.91
Straight Tensile Strength (lbs)
• 3-0 VICRYL Suture displayed greater intrinsic
straight tensile strength than 3-0 Novosyn® Suture
ETHICON, 3-0 VICRYL
B. BRAUN, 3-0 Novosyn
121.1111.4
Intrinsic Straight Tensile Strength (kpsi)
Knot Tensile Strength (lbs)
• 3-0 VICRYL Suture displayed less package memory
than 3-0 Novosyn® Suture
ETHICON, 3-0 VICRYL
B. BRAUN, 3-0 Novosyn
12.17
23.87
Package Memory - Short Pack (%)
Ethicon Sutures
Competitive Performance Testing
Reference: Technical Report PE-2016-0025. January 11, 2017. Ethicon, Inc.55
• 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
3-0 Coated VICRYL® Plus Antibacterial (polyglactin 910) Suture
Competitor
B. Braun 3-0 Novosyn® Suture
Greater straight tensile strength✓Greater knot tensile strength✓Less package memory✓
ETHICON, 3-0 VICRYL Plus
B. BRAUN, 3-0 Novosyn
9.76 9.45
ETHICON, 3-0 VICRYL Plus
B. BRAUN, 3-0 Novosyn
5.314.91
Straight Tensile Strength (lbs)
Knot Tensile Strength (lbs)
• 3-0 VICRYL Plus Suture displayed less
package memory than 3-0 Novosyn® Suture
ETHICON, 3-0 VICRYL Plus
B. BRAUN, 3-0 Novosyn
17.70
23.87
Package Memory - Short Pack (%)
Ethicon Sutures
Competitive Performance Testing
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
Competitive Performance Testing
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
Day 0 Day 28 In Vitro Day 42 In Vitro
100 100
72
88
3
45
% S
tre
ng
th R
ete
nti
on
Day 0 Day 28 In Vitro Day 42 In Vitro
100 100
86
95
17
60
% S
tre
ng
th R
ete
nti
on
MEDTRONIC, Size 3-0 V-Loc 180 Device
ETHICON, Size 3-0 STRATAFIXSpiral PDS Plus Device
MEDTRONIC, Size 4-0 V-Loc 180 Device
ETHICON, Size 4-0 STRATAFIXSpiral PDS Plus Device
Day 0 Day 28 In Vitro Day 42 In Vitro
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
Tissue-Holding Strength (lbf)
MEDTRONIC, 4-0 V-Loc 180 Device
26.923.4
ETHICON, 4-0 STRATAFIX Spiral PDS Plus Device
Tissue-Holding Strength (lbf)
Ethicon Sutures
Competitive Performance Testing
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
Tissue-Holding Strength (lbf)
ETHICON, 4-0 PDS Plus Device
26.9
15.9
ETHICON 4-0 STRATAFIX Spiral PDS Plus Device
Tissue-Holding Strength (lbf)
• 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
Tissue-Holding Strength (lbf)
MEDTRONIC, 4-0 V-Loc 90 Device
22.0 18.6 ETHICON, 4-0 STRATAFIX Spiral MONOCRYL Plus Device
Tissue-Holding Strength (lbf)
14.009.33
Ethicon Regional Sutures
Competitive Performance Testing
Reference: Technical Report PE-2017-0028. September 22, 2017. Ethicon, Inc. 59
Ethicon Suture
2-0 ETHIBOND EXCEL® Polyester Suture
Asia-Pacific Competitor
Alfresa 2-0 Nescosuture® Suture
Greater straight tensile strength✓Greater intrinsic straight tensile strength✓Greater knot security✓
• 2-0 ETHIBOND EXCEL Suture
displayed greater straight
tensile strength than 2-0
Nescosuture® Suture
• 2-0 ETHIBOND EXCEL Suture
displayed greater intrinsic
straight tensile strength than
2-0 Nescosuture® Suture
Testing Outcomes
Straight Tensile Strength (lbs)
ETHICON, 2-0 ETHIBOND
ALFRESA, 2-0 Nescosuture
103.6
60.5
Intrinsic Straight Tensile Strength (kpsi)
ETHICON, 2-0 ETHIBOND
ALFRESA, 2-0 Nescosuture
80
2
Knot Security Occurrences (%)
ETHICON, 2-0 ETHIBOND
ALFRESA, 2-0 Nescosuture
• 2-0 ETHIBOND EXCEL Suture
displayed greater knot
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
ETHICON, DERMABOND ADVANCED Adhesive
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*
• In separate studies, DERMABOND ADVANCED
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
ETHICON, DERMABOND ADVANCED Adhesive
Tensile Strength (lbf)
• In separate studies, DERMABOND ADVANCED
Adhesive displayed greater tensile strength (2-D)
than Liquiband® Exceed™1,4‡
Testing Outcomes
Ethicon Topical Skin Adhesive
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).
ETHICON, DERMABOND ADVANCED Adhesive
with subcuticular 4-0 MONOCRYL Sutures
20.59
13.92
9.30 ETHICON, DERMABOND PRINEO System
ETHICON, DERMABOND ADVANCED Adhesive
without subcuticular sutures
Tissue-Holding Strength (lbs)
Ethicon Topical Skin Adhesives
Competitive Performance Testing
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
Ethicon Topical Skin Adhesive
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
Competitive Performance Testing
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
✓
Ethicon Vascular Access Device Protection
Competitive Performance TestingEthicon IV Protection
BIOPATCH® Protective Disk with CHG
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*
• BIOPATCH Disk is the only
IV dressing with CHG proven
in multiple RCTs to reduce
incidence of CRBSIs in central
venous and arterial catheters1
Maki, et al. 20002 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. 20093 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. 20094 1,636 Use of BIOPATCH Disk led to 69% decrease in CRBSI rate versus
non-chlorhexidine dressings (p=0.03)
66
Ethicon Vascular Access Device Protection
Competitive Performance Testing
*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
DAYS WITH SUSTAINED MICROBICIDAL ACTIVITY UNDER THE DRESSING5*
MRSA MRSE VRE P. aeruginosa A. baumanii K. pneumoniae C. albicans
Ethicon IV Protection
BIOPATCH® Protective Disk with CHG
Competitor
Bard GuardIVa® Antimicrobial Hemostatic IV Dressing
Testing Outcomes
• BIOPATCH Disk is the only
IV dressing with CHG proven
in multiple RCTs to reduce
incidence of CRBSIs in central
venous and arterial catheters1
• Unlike GuardIVa®, 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”
Maki, et al. 20002 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. 20093 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. 20094 1,636 Use of BIOPATCH Disk led to 69% decrease in CRBSI rate versus
non-chlorhexidine dressings (p=0.03)
✓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”
©2018 Ethicon US, LLC. All rights reserved. 063555-180509
67
Ethicon Vascular Access Device Protection
Competitive Performance TestingEthicon IV Protection
BIOPATCH® Protective Disk with CHG
Competitor
Medtronic Kendall™ AMD Antimicrobial Foam Disc Dressing
• Unlike Kendall™, 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 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
DAYS WITH SUSTAINED MICROBICIDAL ACTIVITY UNDER THE DRESSING5*
Testing Outcomes
• BIOPATCH Disk is the only
IV dressing with CHG proven
in multiple RCTs to reduce
incidence of CRBSIs in central
venous and arterial catheters1
Maki, et al. 20002 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. 20093 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. 20094 1,636 Use of BIOPATCH Disk led to 69% decrease in CRBSI rate versus
non-chlorhexidine dressings (p=0.03)
✓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”
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.