PTA Reference Guide - Boston Scientific...PTA REFERENCE GUIDE The Pocket Guide to Our Market-Leading Balloons Portfolio Boston Scientific Confidential. For Internal Use Only. Do Not

PTA REFERENCE GUIDEThe Pocket Guide to Our Market-Leading Balloons Portfolio

Boston Scientific Confidential. For Internal Use Only. Do Not Copy, Display or Distribute Externally. PI-630014-AA

BOSTON SCIENTIFIC OFFERS COMPLIANT AND NON-COMPLIANT PTA

Non-Compliant Balloon• Retains shape

• Transmits greater dilating force at the lesion

• ~4-6% growth within the working range when inflated

Compliant Balloon• Hourglasses or “dog-bones” around lesion

• Provides less dilating force at the lesion

• ~8-10% growth within the working range when inflated

Boston Scientific Confidential. For Internal Use Only. Do Not Copy, Display or Distribute Externally. PI-630014-AB

BALLOON CATHETER DESIGN

Over-the-Wire Balloon Catheter


Distal Bond Profile

Tip Entry Profile

Tapered Tip

Proximal Balloon ProfileLargest outer diameterat the proximal balloon cone

Balloon Materials and Design

Shaft

Inflation Port

Wire Port

Hub

Distal Balloon ProfileLargest outer diameter at the distal balloon cone

Distal Bond Profile

Tapered Tip

Balloon Materials and Design

Shaft

Inflation Port

Rapid-Exchange Guidewire Port

Distal Balloon ProfileLargest outer diameterat the proximal balloon cone

Proximal Balloon ProfileLargest outer diameter at the proximal balloon cone

Hub

Monorail™ Balloon Catheter

BALLOON CATHETER DESIGN


Tip Entry Profile

BalloonDiameter

(mm)

Balloon Length (mm)

20 30 40 60 80 100

4.0 40 atm 40 atm 40 atm 40 atm 40 atm




8.0 31 atm 31 atm 31 atm 31 atm 31 atm 31 atm

9.0 30 atm 30 atm 30 atm

10.0 30 atm 30 atm 27 atm

12.0 20 atm 20 atm 20 atm

ATHLETIS™ ULTRA-HIGH-PRESSURE BALLOON

8F6F 7F

Ultra-High pressures up to 40 ATM


Why Athletis

Breakthrough Ultra-Low Tip Profile

• Class-leading 0.042” tip entry profile*

• Designed to promote crossability through tight stenosis

• Designed to facilitate atraumatic lesion entry

Exceptional Trackability

• Smooth, seamless tip-to-shaft transitions designed to enhance trackability

• Balloon and shaft design promote navigation through tortuous vasculature

Dilatation Efficiency

• Proprietary braided balloon design enables optimized deliverability and ultra-high pressures

• Ultra-low growth beyond stated diameter of <2% even at pressure up to 40 ATM

Available Balloon Lengths

Nominal Pressure

Rated Burst Pressure

Balloon Material

Tip Profile

Available Shaft Lengths

20 – 200 mm 8 ATM Up to 40 ATM Pebax™ 0.042"50 cm, 75 cm,

135 cm

ATHLETIS™ ULTRA-HIGH-PRESSURE BALLOON

1

2

3

Ultra-High Pressure. Ultra-Low Profile. 0.035


ATHLETIS™ VS. COMPETITORS

Trackability 28% lower force than Conquest

350

300

250

200

150

100

50

0

(Bench Test)

Trac

kab

ility

(p

eak

inp

ut

forc

e, g

ram

s)

Athletis™ Conquest 40™ Conquest™

All products 8 x 40 mm balloons. Average measurements taken by Boston Scientific (n = 3). Data on file (TR 92200478).Bench test results may not necessarily by indicative of clinical performance.

S-track Test: Measure of shaft’s ability to maneuver through a tortuous artery model.

255 grams

304 grams

327 grams

Low

er

is P

refe

rre

dBoston Scientific Confidential. For Internal Use Only. Do Not Copy, Display or Distribute Externally. PI-630014-AB

ATHLETIS™ VS. COMPETITORS

Lower compliance compared to Conquest and Conquest 40

*Data from Conquest 40 brochure

Soft Block Test: Measure of balloon’s ability to fully open a resistant lesion model.

All products 8 mm balloons. Average measurements taken by Boston Scientific (n = 15). Data on file (TR 92200478).Bench test results may not necessarily by indicative of clinical performance.

2.5

2

1.5

1

0.5

0

(Bench Test)

Ave

rag

e C

om

plia

nce

(%

)

Athletis™ Conquest™ Conquest™ 40

1.71% 2.2%* 1.22%


BalloonDiameter

(mm)

Balloon Length (mm)

20 30 40 60 80 100 120 150 180 200

3.0

4.0

5.0

6.0

7.0

8.0

9.0

10.0

12.0

MUSTANG™ BALLOON DILATATION CATHETER

5F 6F 7F



Nominal Pressure


Balloon Material

Tip Profile


20 – 200 mm10 ATM (3-8, 12 mm)

8 ATM (9-10 mm)Up to 24 ATM NyBax™ 0.040"

40 cm, 75 cm, 135 cm

MUSTANG™ BALLOON DILATATION CATHETER

1

2

3

Why Mustang

Deliverable High Pressure

24 atmosphere rated burst pressure with a low profile. Nybax balloon material enables great trackability and high pressure in the same balloon.

Broadest Size MatrixBalloon lengths of 20-200 mm. Diameters from 3-12 mm. Available in 40 cm, 75 cm, and 135 cm shaft lengths.

Low ProfileLesion entry only 15% larger than the guidewire. 7 x 200 through 5F, 10 x 80 through 6F.

Excellence on Every Dimension 0.035


MUSTANG™ VS. COMPETITORS

Pushability1100

1050

1000

950

900

850

800

750

700

(Bench Test)

Pu

sh R

esp

on

se (

g/c

m)

Mustang™ Dorado™ PowerFlex™P3

Ultra-thin™Diamond™

AdmiralXtreme™

Conquest™ FoxCross™ EverCross™

All products 6x40 mm balloons.Average measurements taken by Boston Scientific (n=3). Data on file. (test 90143171).Bench testing may not be representative of clinical performance.

Push Response Test: Measure of shaft’s ability to transmit force to distal tip in straight-line configuration.

Hig

he

r is

Pre

ferr

ed


MUSTANG™ VS. COMPETITORS

Trackability

350

300

250

200

150

100

50

0

(Bench Test)

Trac

k (p

eak

inp

ut

forc

e, g

)

Mustang™ EverCross™ FoxCross™ AdmiralXtreme™

PowerFlex™

P3Ultra-thin™Diamond™

Conquest™ Dorado™


All products 6x40 mm balloons.Average measurements taken by Boston Scientific (n=3). Data on file. (test 90555708).Bench testing may not be representative of clinical performance.

Low

er

is P

refe

rre

d


BalloonDiameter

(mm)

Balloon Length (mm)

20 30 40 60 80 100 120 150 180 200

3.0

4.0

5.0

6.0

7.0

8.0

9.0

10.0

12.0

CHARGER™ BALLOON DILATATION CATHETER

5F 6F 7F


Why Charger

Post-Stent Dilatation Higher pressure when needed (up to 20 atm for 5 x 200 mm). Non-compliant for excellent stent-to-wall apposition.

Broad Size Matrix Balloon lengths of 20-200 mm. Diameters from 3-12 mm. Available in 40 cm, 75 cm, and 135 cm shaft lengths.

Low Profile0.040" tip over a 0.035" guidewire. 6 x 150 mm and 7x80 mm through 5 F. 10 x 80 mm through 6 F. Excellent rewrap.


Nominal Pressure


Balloon Material

Tip Profile


20 – 200 mm10 ATM (3-8, 12 mm)

8 ATM (9-10 mm)Up to 20 ATM NyBax™ 0.040"

75 cm, 135 cm

CHARGER™ BALLOON DILATATION CATHETER

1

2

3

Count On It 0.035


1100

1050

1000

950

900

850

800

750

700

(Bench Test)P

ush

Re

spo

nse

(g

/cm

)

Charger™ PowerFlex™P3

Ultra-thin™Diamond™

AdmiralXtreme™

FoxCross™ EverCross™

CHARGER™ VS. COMPETITORS

Pushability


All products 6x40 mm balloons. Average measurements taken by Boston Scientific (n=3). Data on file. (test 90143171). Bench testing may not be representative of clinical performance

Hig

he

r is

Pre

ferr

ed


CHARGER™ VS. COMPETITORS

Withdrawal

1.6

1.4

1.2

1

0.8

0.6

0.4

0.2

0

Through a 5 F Sheath(Bench Test)

Wit

hd

raw

al F

orc

e (

lbs)

Charger™ AdmiralXtreme™

EverCross™ PowerFlex™ P3

FoxCross™

All products 6x40 mm balloons. Average measurements taken by Boston Scientific (n=3). Data on file (90137811). Bench testing may not be representative of clinical performance.

Low

er

is P

refe

rre

d


BalloonDiameter

(mm)

Balloon Length (mm)

20 40 60 80

4.0

5.0

6.0

7.0

8.0

9.0

10.0

12.0

GLADIATOR™ ELITE BALLOON DILATATION CATHETER

5F 6F 7F

OBL ONLY



Nominal Pressure


Balloon Material

Tip Profile


20 – 80 mm10 ATM (3-8, 12 mm)

8 ATM (9-10 mm)Up to 24 ATM PeBax™ 0.037"

40 cm, 75 cm

Why Gladiator Elite

Deliverable High Pressure

24 atmosphere rated burst pressure with a low profile. Non-compliant.

Durable DesignInnovative tri-layer balloon technology for enhanced durability in challenging lesions.

Low Profile0.037" tip over a 0.035" guidewire. 7 x 80 mm through 5 F. 10 x 80 mm through 6 F.

1

2

3

GLADIATOR™ ELITE BALLOON DILATATION CATHETER

Powerful Dilatation with Agility 0.035


(Bench Test)

Gladiator™ Elite Ultra-thin™Diamond™

Blue Max™ Conquest™ Dorado™

GLADIATOR™ ELITE VS. COMPETITORS

Trackability


All products 6 x 40 mm balloons.Average measurements taken by Boston Scientific (n = 3). Data on file (TR 90909453).Bench test results may not necessarily be indicative of clinical performance.

350

300

250

200

150

100

50

0

Trac

k (p

eak

inp

ut

forc

e, g

)

Low

er

is P

refe

rre

d


GLADIATOR™ ELITE VS. COMPETITORS

Withdrawal

3.0

2.5

2.0

1.5

1.0

0.5

0.0

Through a 6 F Sheath(Bench Test)

Wit

hd

raw

al F

orc

e (

lbs)

Gladiator™ Elite Ultra-thin™Diamond™

Conquest™ Dorado™ Blue Max™

Low

er

is P

refe

rre

d

All products 6 x 40 mm balloons. Average measurements taken by Boston Scientific (n = 3). Data on file (TR 90909453). Bench test results may not necessarily be indicative of clinical performance.


BalloonDiameter

(mm)

Balloon Length (mm)

20 40 60

12.0

14.0

16.0

18.0

XXL™ BALLOON DILATATION CATHETER

7F

*16-18 mm - Indicated for Esophageal Procedures Only



Nominal Pressure


Balloon Material


20 –60 mm8 ATM (13-14 mm)5 ATM (16-18 mm)

Up to 8 ATM Selar™75 cm, 120 cm

XXL™ BALLOON DILATATION CATHETER

Trusted Strength

Why XXL

Low Profile12 mm and 14 mm diameter balloons compatible with 7F sheaths.

Non-Compliant Design

Strong material designed to enhance radial force without deformation for a predictable balloon diameter

Superb Pushability and Trackability

Quadra-Fold technology for tight rewrapping of balloon around catheter shaft for a low deflated profile.

1

2

3

0.035


BalloonDiameter

(mm)

Balloon Length (mm)

10 15 20 30 40 60 80 100 120 150 200 220

2.02.53.03.54.04.55.05.56.06.57.08.09.010.0

STERLING™ AND STERLING™ SL BALLOON DILATATION CATHETER

STERLING OTW & MR

5F4F4F6F5F4F

STERLING OTW STERLING MR



Nominal Pressure


Balloon Material

Tip Profile


10 – 220 mm 6 ATM Up to 14 ATM Pebax™ 0.020"40 cm, 80 cm, 90 cm, 135 cm,

150 cm

Demand More

Why Sterling

Breakthrough Deliverability

Laser-bonded, tapered tip designed to promote crossability through tight stenosis and near occlusions. Semi-compliant Pebax balloon material.

Broadest Size Matrix The most comprehensive size offering available in both over-the-wire and monorail rapid-exchange. Indicated for wider acute use including carotid.

Low Profile Exceptionally low 0.020" lesion entry profile on a 0.018" guidewire. 7 x 220 mm through 5F. Flexible tip promotes easy navigation through tortuous vasculature.

1

2

3

STERLING™ AND STERLING™ SL BALLOON DILATATION CATHETER

0.018


STERLING™ VS. COMPETITORS

Tip Entry Profile

0.035

0.03

0.025

0.02

0.015

0.01

(Bench Test)P

rofi

le (

inch

es)

Sterling™ PowerCross™ Pacific™

XtremeUltraverse™

018Savvy™ Long

Low

er

is P

refe

rre

d

Tip entry measurements performed at the distal-most portion of the tip. Average measurements taken by Boston Scientific (n=3, 5 mm x 150 mm balloons). Data on file. (TR 90884555). Bench testing may not be representative of clinical performance.


(Bench Test)

Sterling™ Ultraverse™

018Savvy™ Long Pacific™ Xtreme PowerCross™

STERLING™ VS. COMPETITORS

Trackability


Tip entry measurements performed at the distal-most portion of the tip. Average measurements taken by Boston Scientific (n=3, 5 mm x 150 mm balloons). Data on file. (TR 90884555). Bench testing may not be representative of clinical performance. All photographs are property of Boston Scientific.

240

220

200

180

160

140

120

100

Trac

k (p

eak

inp

ut

forc

e, g

)

Low

er

is P

refe

rre

d


BalloonDiameter

(mm)

Balloon Length (mm)

20 30 40 60 80 100 120 150 220

1.5

2.0

2.5

3.0

3.5

4.0

COYOTE ES OTW & MR COYOTE OTW & MR

COYOTE™ AND COYOTE™ ES BALLOON DILATATION CATHETER

4F4F



Nominal Pressure


Balloon Material

Tip Profile


20 – 220 mm8 ATM (Coyote)

6 ATM (Coyote ES)Up to 14

ATMNyBax™ 0.017"

90 cm, 142 cm, 143 cm, 144 cm, 145 cm, 146 cm, 150 cm

COYOTE™ AND COYOTE™ ES BALLOON DILATATION CATHETER

Get To. Get Through. Get Going.

Why Coyote

Fast Deflation Deflation time of less than 10 seconds.

Excellent Trackability Available in four configurations: over-the-wire and Monorail platforms on 90 cm and 150 cm shaft lengths optimized for maximum push and excellent track.

Low Profile Ultra-low 0.017" lesion entry profile and best-in-class 0.030" crossing profile.

1

2

3

0.014


COYOTE™ VS. COMPETITORS

Pushability

800

700

600

500

400

300

200

(Bench Test)P

ush

Re

spo

nse

(g

/cm

)

Coyote™ Sleek™ NanoCross™ AmphirionDeep™

SAVVY™Long

Ultraverse™

014Armada™ 14

Average measurements taken by Boston Scientific (n=3, 2 mm x 120 mm balloons). Data on file (TM 90110865, 90226022, 90143171, 90483622). Bench test results may not necessarily be indicative of clinical performance.


Hig

he

r is

Pre

ferr

ed

OTW

Mo

no

rail™


COYOTE™ VS. COMPETITORS

Trackability

40

36

32

28

24

20

(Bench Test)Tr

ack

(pea

k in

pu

t fo

rce,

g)

Coyote™ SAVVY™Long

Sleek™ Ultraverse™

014Armada™ 14 Amphirion

Deep™NanoCross™

Average measurements taken by Boston Scientific (n=3, 2 mm x 120 mm balloons). Data on file (TM 90110865, 90226022, 90143171, 90483622). Bench test results may not necessarily be indicative of clinical performance.


Low

er

is P

refe

rre

d

OTW

Mo

no

rail™


BalloonDiameter

(mm)

Balloon Length (mm)

20

5.0

6.0

7.0

8.0

PERIPHERAL CUTTING BALLOON™MICROSURGICAL DILATATION DEVICE FOR HEMODIALYSIS ACCESS MANAGEMENT

7F6F



Nominal Pressure


Balloon Material


20 mm 6 ATM Up to 10 ATMPolyethlene Terapthalate

(PET)

50 cm, 90 cm, 135 cm

The Proven Solution

Why Peripheral Cutting Balloon

Controlled Dilatation Designed for predictable, controlled dilatation.

Superior Results Over POBA

63% 12-month primary patency using PCB in arteriovenous stenosis vs 37% 12-month primary patency for conventional PTA.

Superior Results Over High Pressure PTA

66% 6-month primary patency using PCB in arteriovenous stenosis vs 40% 6-month primary patency for high pressure PTA.

1

2

3

0.018

PERIPHERAL CUTTING BALLOON™MICROSURGICAL DILATATION DEVICE FOR HEMODIALYSIS ACCESS MANAGEMENT


ENCORE™ 26 INFLATOR

• Sold individually or a box of 5

• Inflates up to 26 ATMs

• 20 ml Inflation capability, complete with pressure gauge

• Large printed pressure gauge dial with finger latch mechanism for 1-step locking and pressure release

The Encore 26 Inflation Device is recommended for use with balloon dilatation catheters to create and monitor pressure in the balloon, and to deflate the balloon.


ENCORE™ 40 INFLATOR

• Inflates up to 40 ATMs

• 25 cc capacity, complete with pressure gauge

• Large printed pressure gauge that glows in the dark for easy reading in dark labs

• Quick latch mechanism allows for rapid deflation, even from max pressure.

• Clear barrel provides a precise view of the content and volume allowing user to perform thorough purging.


PTA SUPPORT


Bre

adth

an

d D

epth

of

Pro

du

cts

We believe the best way to help our customers achieve the patient outcomes they’re looking for is to provide best-in-class support and service.

Customer Satisfaction

Our balloons portfolio is the ideal balance between highest quality PTA products and market-leading breadth of offerings.

Peripheral Interventions300 Boston Scientific WayMarlborough, MA 01752-1234www.bostonscientific.com

To order product or for more informationcontact customer service at 1.888.272.1001.

© 2020 Boston Scientific Corporationor its affiliates. All rights reserved.

PI-630014-AB

Boston Scientific Confidential. For Internal Use Only. Do Not Copy, Display or Distribute Externally. Mustang, Charger, Gladiator Elite, XXL, Sterling and Peripheral Cutting Balloon are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. All other trademarks are property of their respective owners.

Documents

PTA Reference Guide - Boston Scientific...PTA REFERENCE GUIDE The Pocket Guide to Our Market-Leading Balloons Portfolio Boston Scientific Confidential. For Internal Use Only. Do Not