Scoreflex PTA

PTA Balloon Catheter

Lowest profile scoring
for safe and effective plaque modification

Focused Force Angioplasty for Safe and Controlled Dilatation

Scoreflex PTA is a focused force dilatation balloon with a dual-wire system which creates a focal stress pattern to facilitate safe and controlled plaque modification at lower resolution pressure.

Advance a standard guidewire across the target lesion.

Advance Scoreflex PTA over the guidewire and cross the target lesion.

Inflate the Scoreflex PTA balloon in a stepwise fashion.

Withdraw the deflated Scoreflex PTA once the desired result is achieved.

G-70-1159 Rev01

Scoreflex PTA construction

TIP

A short rapid exchange tip with the guidewire exit port proximal to the tip

WIRE

A nitinol integral wire, welded from tip to hypotube, serving as one of the scoring elements

MARKERS

Two radiopaque markers on the integral wire aligned to the balloon shoulders

The guidewire exits proximal to the tip and acts as the second scoring element

Catheter for excellent deliverability

Continuous hub-to-tip metallic construction for enhanced pushability, with a
combination of hydrophilic and hydrophobic coatings to minimize friction

Hydro-X hydrophilic coating adds lubricity to reduce friction to enhance crossability

IMPROVES CROSSABILITY

Invio hydrophobic coating is a water-repellent and minimizes guidewire friction

IMPROVES TRACKABILITY

G-70-0697 Rev03

Anatomy	AV Fistula	SFA	BTK
Proximal Shaft	2.5F	2.5F	2.3F
Distal Shaft	3.5F	3.5F	2.9F
Catheter Working Length	40 cm	90 cm	150 cm
Tip Length	11 mm	11 mm	11 mm
Scoring Elements	0.014” Integral guidewire; 0.018″ conventional guidewire	0.014” Integral guidewire; 0.018″ conventional guidewire	0.011” Integral guidewire; 0.014″ conventional guidewire
Marker Bands	2	2	2
Nominal Pressure	6 atm	6 atm	6 atm
Rated Burst Pressure	14 atm	14 atm	14 atm
Coating	Hydrophilic (tip & distal shaft); Hydrophobic (guidewire lumen & balloon)	Hydrophilic (tip & distal shaft); Hydrophobic (guidewire lumen & balloon)	Hydrophilic (tip & distal shaft); Hydrophobic (guidewire lumen & balloon)
Minimum Sheath Size	5F (4.0 – 5.0 mm); 6F (6.0 mm)	5F (4.0 – 5.0 mm); 6F (5.5 – 6.0 mm)	4F
Crossing Profile	0.043″ (Ø 4.0 mm)	0.038″ (Ø 3.0 mm)	0.036″ (Ø 3.0 mm)
Balloon Material	Nylon	Nylon	Nylon
Balloon Compliance	Semi-Compliant	Semi-Compliant	Semi-Compliant

Anatomy

AV Fistula

SFA

BTK

Proximal Shaft

2.5F

2.3F

Distal Shaft

3.5F

2.9F

Catheter Working Length

40 cm

90 cm

150 cm

Tip Length

11 mm

Scoring Elements

0.014” Integral guidewire;
0.018″ conventional guidewire

0.011” Integral guidewire;
0.014″ conventional guidewire

Marker Bands

Nominal Pressure

6 atm

Rated Burst Pressure

14 atm

Coating

Hydrophilic (tip & distal shaft);
Hydrophobic (guidewire lumen & balloon)

Minimum Sheath Size

5F (4.0 – 5.0 mm); 6F (6.0 mm)

5F (4.0 – 5.0 mm); 6F (5.5 – 6.0 mm)

Crossing Profile

0.043″ (Ø 4.0 mm)

0.038″ (Ø 3.0 mm)

0.036″ (Ø 3.0 mm)

Balloon Material

Nylon

Balloon Compliance

Semi-Compliant

Pressure (atm)	Balloon Diameter (Ø mm)
	2.0	2.5	3.0	3.5	4.0	4.5	5.0	5.5	6.0
2	1.92	2.42	2.89	3.38	3.85	4.29	4.79	5.25	5.72
4	1.96	2.46	2.95	3.44	3.93	4.40	4.89	5.37	5.86
6 NOM*	2.00	2.50	3.00	3.50	4.00	4.50	5.00	5.50	6.00
8	2.04	2.54	3.05	3.56	4.07	4.60	5.11	5.63	6.14
10	2.08	2.58	3.11	3.62	4.15	4.71	5.21	5.75	6.28
12	2.12	2.63	3.16	3.68	4.22	4.81	5.32	5.88	6.42
14 RBP**	2.16	2.67	3.21	3.74	4.30	4.91	5.43	6.01	6.56
16	2.20	2.71	3.27	3.80	4.37	5.02	5.54	6.13	6.70
18	2.24	2.75	3.32	3.85	4.45	5.12	5.64	6.26	6.84

Pressure (atm)

Balloon Diameter (Ø mm)

2.0

2.5

3.0

3.5

4.0

4.5

5.0

5.5

6.0

1.92

2.42

2.89

3.38

3.85

4.29

4.79

5.25

5.72

1.96

2.46

2.95

3.44

3.93

4.40

4.89

5.37

5.86

6 NOM*

2.00

2.50

3.00

3.50

4.00

4.50

5.00

5.50

6.00

2.04

2.54

3.05

3.56

4.07

4.60

5.11

5.63

6.14

2.08

2.58

3.11

3.62

4.15

4.71

5.21

5.75

6.28

2.12

2.63

3.16

3.68

4.22

4.81

5.32

5.88

6.42

14 RBP**

2.16

2.67

3.21

3.74

4.30

4.91

5.43

6.01

6.56

2.20

2.71

3.27

3.80

4.37

5.02

5.54

6.13

6.70

2.24

2.75

3.32

3.85

4.45

5.12

5.64

6.26

6.84

Balloon Diameter (Ø mm)	Balloon Working Length (mm)
	20	40
4.0	●	●
5.0	●	●
6.0	●	●

Balloon Diameter (Ø mm)

Balloon Working Length (mm)

4.0

●

5.0

●

6.0

●

Balloon Diameter (Ø mm)	Balloon Working Length (mm)
	20	40
4.0	●	●
4.5	●	●
5.0	●	●
5.5	●	●
6.0	●	●

Balloon Diameter (Ø mm)

Balloon Working Length (mm)

4.0

●

4.5

●

5.0

●

5.5

●

6.0

●

Balloon Diameter (Ø mm)	Balloon Working Length (mm)
	15	20	40
2.0	●	●	●
2.5	●	●	●
3.0	●	●	●
3.5	●	●	●
4.0	●	●	●

Balloon Diameter (Ø mm)

Balloon Working Length (mm)

2.0

●

2.5

●

3.0

●

3.5

●

4.0

●

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Scoreflex PTA

Lowest profile scoring
for safe and effective plaque modification

Focused Force Angioplasty for Safe and Controlled Dilatation

Scoreflex PTA construction

Catheter for excellent deliverability

Technical Specifications

AV Fistula and SFA

BTK

Compliance chart

Available Configurations for AV Fistula (0.018″ system)

Available Configurations for SFA (0.018″ system)

Available Configurations for BTK (0.014″ system)

Balloon Diameter (Ø mm)	Balloon Working Length (mm)
	15	20	40
2.0	●	●	●
2.5	●	●	●
3.0	●	●	●
3.5	●	●	●
4.0	●	●	●

Balloon Diameter (Ø mm)	Balloon Working Length (mm)
	15	20	40
2.0	●	●	●
2.5	●	●	●
3.0	●	●	●
3.5	●	●	●
4.0	●	●	●

Scoreflex PTA

Lowest profile scoring for safe and effective plaque modification

Focused Force Angioplasty for Safe and Controlled Dilatation

Scoreflex PTA construction

Catheter for excellent deliverability

Technical Specifications

AV Fistula and SFA

BTK

Compliance chart

Available Configurations for AV Fistula (0.018″ system)

Available Configurations for SFA (0.018″ system)

Available Configurations for BTK (0.014″ system)

Lowest profile scoring
for safe and effective plaque modification

Balloon Diameter (Ø mm)	Balloon Working Length (mm)
	15	20	40
2.0	●	●	●
2.5	●	●	●
3.0	●	●	●
3.5	●	●	●
4.0	●	●	●