Balloon Design and Performance: Presentation of various types of

Balloon Design and Performance: Presentation of various types of

Balloon Design and Performance: Presentation of various types of balloons on the market CHICAGO BALLOON SUMMIT 2016 Demetrius Lopes, MD Balloon Sum...

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Balloon Design and Performance: Presentation of various types of balloons on the market

CHICAGO BALLOON SUMMIT 2016 Demetrius Lopes, MD

Balloon Summit: So much to talk about Non-Compliant & Semi-Compliant Balloons

Compliant Balloons

Super-Compliant Balloons

Balloon Material/Construction

Complaint

Non-complaint

–Chronoprene –Polyurethane

–Nylon –PBx

Compliant Balloons • Over-the-wire and designed for use in the neurovasculature • Low pressure – less traumatic • Typically 0.5 atm (380 mmHg)

Single Lumen Balloon TransForm

ECLIPSE

COPERNIC

Hyperform

Hyperglide

Hyperballoon Size chart Hyper Balloon Options Sizes

Durometer/Pressure

Indication

HyperGlide™ 3.0 mm 3.0 x 10 mm 3.0 x 15 mm

Compliant D = 40

Balloon Test Occlusion

HyperGlide 4.0 mm 4.0 x 10 mm 4.0 x 15 mm 4.0 x 20 mm 4.0 x 30 mm HyperGlide 5.0 mm 5.0 x 15 mm 5.0 x 20 mm 5.0 x 30 mm HyperForm™ 3.0 x 7 mm 3.0 x 15 mm 4.0 x 7 mm 4.0 x 15 mm 4.0 x 20 mm 7.0 x 7 mm 7.0 x 15 mm

Low Pressure

Compliant D = 40 Low Pressure Compliant D = 40 Low Pressure

Super-Compliant D = 15 Low Pressure

Balloon Test Occlusion, Balloon-Assisted Coiling

Balloon Test Occlusion, Balloon-Assisted Coiling

Balloon Test Occlusion, Balloon-Assisted Coiling

Size Chart For Transform Balloon

Compliant (mm/mm) 10

15

20

30

3





4









5









Super Compliant (mm/mm) 5

7

10

4





7





3

15





Size Chart for Eclipse and Copernic REFERENCE

Catheter length (cm)

Balloon length (mm)

Balloon Ø (mm)

Volume max (mL)

OD max

Guidewire

/

HYBRID121 4

COPERNIC10

10

COPERNIC15

15

COPERNIC20

20

COPERNIC30

30

COPERNIC8X8 0RC

80

8

/

4,35F (1,45mm)

TRANSEND 14

80

10

/

5F (1,6mm)

TRANSEND 14

/

HYBRID121 4

COPERNIC10X 80RC

160

0,30 3 to 5

0,35 0,40 0,50

ECLIPSE7

7

0,20

ECLIPSE9

9

0,25

ECLIPSE12

12

ECLIPSE15

15

0,40

ECLIPSE20

20

0,50

4 to 6

0,30

ECLIPSE also compatible with the exchange guide HYBRID10/12D300 (length  300cm) ‘ECLIPSE’ or ‘COPERNIC’  set which includes: 1 microcatheter / 1 GW HYBRID1214D / 1 TORQUE / 1 Y shaped valve connector

COPERNIC RC 8x80

COPERNIC RC 8x80

Dual Lumen Balloon

Eclipse 2L NeuroSpeed Accent - X-tra Compliant

Eclipse 2L sizing chart REFERENCE

Balloon length (mm)

Balloon Ø (mm)

Distal tip (OD x length)

I.D (main lumen)

Double lumen O.D (thickness)

Double lumen O.D (width)

N° of markers

ECL2L6X7SN 7 ECL2L6X9

2,0F x 3mm

9

Ø 0,42mm (.017’’) Equivalent to VASCO+10

6 ECL2L6X12 12

ECL2L6X20

20

4

2,0F x 7mm

0,9mm (equivale nt to 2,7F)

1,15mm *

3

Scepter sizing

NeuroSpeed® PTA Balloon Product Overview The NeuroSpeed® PTA Balloon Catheter is indicated for dilatation of a stenosis in the cerebral arteries in order to improve perfusion.

NeuroSpeed® PTA Balloon Catheter Balloon diameter

1.5 / 2.0 / 2.5 / 3.0 / 3.5 and 4.0 mm

Balloon working length

8 mm

Inner diameter

0,0165‘‘

Outer diameter (dist./ prox.)

2.7 F / 3.7 F

Usable length

150 cm

Tip length

10 mm

Tip markers / Balloon markers

1/2

14

NeuroSpeed® PTA Balloon Catheter Product Overview – Radiopaque Marker Longer soft tip for improved trackability

One radiopaque marker indicating the distal tip of the catheter ( For positioning control)

15

Two radiopaque markers indicating the nominal length of the balloon

Flow-dependant microcatheters with non-detachable balloon

BALTACCI B1

MAGIC B1/B2 Common indications: • Bifurcation remodeling with round balloon • Vasospasm • Temporary balloon occlusion

BALTACCI

Flow Guided Balloon Chart REFERENCE

Balloon length (mm)

Balloon Ø (mm)

Max volume (mL)

Torver + hub Ø x L (cm)

Middle part Ø x L (cm)

Distal part Ø x L (cm)

Total length (cm)

BALTACCI B1

6 to 9

4 to 6

0,20

2,7F x 135

2,4/1,5F x 20

1,5F x 10

165

MAGIC

REFERENC E MAGIC B1

Balloon length (mm)

Balloon Ø (mm)

9

Torver Ø x L (cm)

Pink Pursil Ø x L (cm)

White Pursil Ø x L (cm)

Total length (cm)

2,7F x 114

2,4F x 25

1,8F x 10

155

2,7F x 114

2,4F x 25

1,8F x 10

155

6 MAGIC B2

18

Performance Comparison

What is the difference between single vs dual balloon?  Single Lumen Balloon Catheter

Dual Lumen BalloonCatheter

• • • • •

• • • • •

Less Dense Smaller Profile More Flexible Air Removal Independent of Vent Holes Mechanical Seal

More Dense (2 lumens) Larger Profile Time Consuming Preparation Less Versatile Relies on occlusion of vent holes by contrast to create seal

• Single vs Double Lumen

OVERVIEW OF HYPER BALLOONS INFLATION/DEFLATION •

Inflation/Deflation occurs through inflation holes when guidewire seals distal aperture



50% contrast and saline solution recommended to inflate balloon

Balloon Catheter Overview - Transform



Catheter Length: 150cm



Proximal OD: 2.8F



Distal OD: 2.7F



Distal Tip: 3.25mm



Fluoro Saver Marker: 94cm from distal tip



Parallel Technique: Compatible in a 6F Guide



DMSO Compatible

Balloon Construction Nominal Balloon Length 0.6mm

0.6mm

• Balloon made from a thermoplastic elastomer • Balloon mounted on a nitinol slotted hypotube with hundreds of micromachined ports for contrast infusion • Balloon material is DMOS compatible

Older technology: Infusion holes on polymer shaft

Newer technology: Nitinol hypotube

50% Contrast

100% Contrast

2.5

2.5

2

2

1.5

1.5

1

1

0.5

0.5

0

0

Inflate

Deflate Transform

HyperGlide

Inflate Ascent

Scepter C

Deflate

OVERVIEW OF HYPER BALLOONS INFLATION



Advance distal 10cm of guidewire to or past the catheter tip



Use Cadence™ syringe to inject contrast/saline solution

Wire distal=inflate

Technical Design Dual Lumen

Distal Tip Marker

Polyurethane Balloon Material •Very durable and thin •Allows hydrophilic coating on the balloon •Small crossing profile De-airing Channel •Makes balloon prep easier and faster

Distal 5mm Tip •Steam shapeable •Very soft

Balloon Markers

Technical Design Dual Lumen

Air

Air-purge Hole • For quick air-purging • Filled with contrast solution after airpurging • Can be closed with steaming after prepping

Inflation Plug • Unifies the inner and outer members • Enhances reliable balloon deflation

Contrast Solution

FLAT CATHETER CONCEPT Inflation tube

Infusion catheter •

Wide lumen to both the inflation tube & the infusion catheter which enables the use in parallel of the remodeling balloon & a guide, stent, liquid embolic or coiling microcatheter in a single 6F guiding catheter



The wide inflation tube allows a much better control of the inflation / deflation. The ECLIPSE 2L deflates 5 times quicker than competitor’s balloons on a coaxial catheter - 8 seconds for the ECLIPSE - 40 seconds for other 2L balloon



Quick inflation / deflation time of the balloons, a wider range of balloons can be proposed : up to

20 mm long

• 100% contrast solution

Other balloon

2L

coaxial double lumen I.D. .017’’(0,43mm) 1 lumen for Balloon I.D. .017’’(0,43mm)

Balloon GuideWir e Coils Stent

ECLIPSE 2L

ECLIPSE Single lumen I.D. .024’’ HYBRID1214

1 lumen for : GuideWire Coils Stent I.D. .017’’(0,43mm)

Balloon

I.D. Ø 1,78mm FRGMAX

I.D. Ø 1,78mm FRGMAX

O.D. Ø 0,80mm VASCO+10 / ECHELON10

O.D. Ø 0,80mm VASCO+10 / ECHELON10

Double microcatheter: compatibility with 0.070” ID Guide Catheter Insert Microcatheter first and Balloon Occlusion Catheter second!!!!!

Balloon Microcatheter

Balloon

6F Guide

Total outer diameters (balloon + microcatheter) Microcatheter

Green: Can be used without friction Yellow: The balloon must be inserted before a microcatheter Red: Cannot be used together Total outer diameter (inch)

Microcatheter

Max OD (inch)

Headway Duo

Scepter C/XC .037

HyperGlide™ HyperForm™ 4mm .040

HyperForm ™ 7mm .046

Ascent® .038

Eclipse .037

Copernic .035

Eclipse 2L .045

Copernic 2L .050

TransForm™ .041

.028

.065

.068

.074

.066

.065

.063

.073

.078

.069

Headway17

.030

.067

.070

.076

.068

.067

.065

.075

.080

.071

Headway21

.031

.068

.071

.077

.069

.068

.066

.076

.081

.072

SL10

.030

.067

.070

.076

.068

.067

.065

.075

.080

.071

Echelon10

.028

.065

.068

.074

.066

.065

.063

.073

.078

.069

Echelon14

.030

.067

.070

.076

.068

.067

.065

.075

.080

.071

Prowler14

.030

.067

.070

.076

.068

.067

.065

.075

.080

.071

Excel14

.032

.069

.072

.078

.070

.069

.067

.077

.082

.073

Excelsior1018

.034

.071

.074

.080

.072

.071

.069

.079

.084

.075

Air Purging vs. Blood Aspiration

VS.

EASY VALVE PURGING SYSTEM WITH NO BACK FLOW The new design is particularly helpful for purging the air out of the balloon. Risk of blood aspiration while deflating the device : - No need to seal the purge with hot air - No risk of damaging the balloon

Deflation Time Approximate Balloon Deflation Time (seconds) 4x10

4x15

4x20

Scepter XC 4x11

9

12

14

8

Scepter C

Contrast Name Contrast:Saline Omnipaque™ 300

50:50

 Deflation time of the Hyper Balloons is 18-35 sec with 50:50 contrast-saline solution (Omnipaque™300) according to the IFU.  Deflation time of the TransForm™ balloon is 10 sec with 50:50 contrast-saline solution (Omnipaque™ 300) according to the IFU.

Balloon compliance vs length difference? Scepter XC 4x11

HyperForm™ 4x7

Barrel Stent

Center Markers (x6) Distal Barrel Marker

Proximal Barrel Marker Distal Markers (x3)

Should we calculate bifurcation span to choose balloon? OR Should balloon disclose its bifurcation span?

Catheter Construction •

Single lumen balloon sealed by an 0.014 in guidewire that is passed through the distal tip



Catheter made of multi-durometer __________ polymers to obtain variable stiffness from proximal end to distal end



Catheter length is reinforced with braided metal



Hydrophilically coated



Inner shaft has a lubricious liner

Shared lumen

Proximal Fluoro Saver Marker Shaft wall

Coil vs Braid Reinforcement + Balloon Stability

Single Coil reinforced

Double Coil reinforced

Scepter No reinforced

Single Coil reinforced

HyperForm/Glide™ Laser cut design

Braided reinforced

TransForm™

Scepter

Designed for Stability and Trackability Catheter shaft support profile optimizes balance between stability and trackability

Distal Tip Deflection Test The distal 5mm of the Scepter C and XC Balloon are:  11.7% softer than the HyperGlide™ Catheter  100% softer than the Ascent® Catheter  5.8% softer than the Copernic Catheter  35.2% softer than the TransForm™ Catheter 2mm/min

Test Appar atus

0

Fixed at 5mm from the distalThe balloon tip

30

Recording the maximum load

Less Deflection = Softer Tip 0.8 0.7

0.6 0.5

gf

0.4

0.3 0.2 0.1

0

Scepter C Scepter XC HyperGlide Ascent

Copernic TransForm

hydrophilic coating Balloon

Hydrophilic coating on the balloon and catheter shaft assist the trackability of the Scepter balloon

Hydrophilic coating on the balloon

MV

Covidien

Scepter C Scepter XC

HyperGlide™ HyperForm™

TransForm™

Yes

No

No

Scepter

HyperForm™

TransForm™

Hydrophilic coating

Stryker

compliance chart Balloon Inflation Compliance Scepter C Dia., (mm)

Scepter XC Dia., (mm)

4x10 4x15 4x20

0.02 0.04 0.06 0.08 0.10 0.12 0.14 0.16 0.18 0.20 0.22 0.24 0.26 0.28 0.30 0.32** 0.34 0.36 0.38** 0.40 0.42 0.44 0.46** *After Priming Catheter

1.9 2.6 3.0 3.2 3.5 3.6 3.8 4.0 4.1 4.2 4.4 4.5 4.6 4.7 4.8 4.9

1.8 2.4 2.9 3.2 3.4 3.5 3.7 3.8 4.0 4.1 4.2 4.3 4.5 4.6 4.7 4.8 4.9 4.9 5.0

Scepter Compliance Chart

4x11

1.8 2.4 2.8 3.1 3.3 3.4 3.6 3.7 3.8 3.9 4.0 4.1 4.2 4.3 4.4 4.4 4.5 4.6 4.6 4.7 4.8 4.9 4.9

**Maximum Injection Volume

1.8 2.6 3.2 3.6 3.9 4.2 4.5 4.7 4.9 5.0 5.2 5.3 5.5 5.6 5.7 5.9

6.0

XC

5.5

5.0

Balloon Diameter (mm)

Inflation Volume* (cc)

C 4x10

4.5

4.0

3.5

3.0

2.5

2.0

1.5

Injection Volume

C 4x15

C 4x20

Clinical Applications

Indications Distal & bifurcation remodeling (smaller vessels) Vasospasms

Temporary occlusion tests

Carotid Syphon Remodeling

balloon assisted coiling

Step 1: Jail microcatheter and inflate balloon

Step 2: Begin to coil aneurysm

Step 3: Deflate balloon and check for stability within the coil mass.

Step 4: Remove microcatheter and balloon.

Stent delivery

1 - Balloon assisted embolization

2 - After balloon deflation, some coil prolapses into the parent vessel

4 – Deploy the stent * Regulatory approval may vary per countries

3 – Deliver LVIS Jr device through Scepter Balloon

5 – The stent is placed in the parent vessel

LE INJECTION THROUGH SCEPTER BALLOON

Liquid embolic such as Onyx™ Liquid Embolic can be infused through working lumen of the Scepter Balloon with the balloon inflated. •Dead space of the working lumen is 0.44cc •Distal tip length is 5mm •Distal tip steaming prior to use may be recommended in order to prevent gradual balloon deflation over the time (about 5 min depending on viscosity of contrast solution)

BAC APPLICATIONS Sidewall Aneurysm

BAC APPLICATIONS Efferent Artery Protection

BAC APPLICATIONS

Heel of the Balloon

BAC APPLICATIONS

Toe of the Balloon

Heel of the Balloon

BAC APPLICATIONS Tip of the Balloon

BAC APPLICATIONS Dual Balloon Technique

Coiling with two balloon remodeling the aneurysm neck

BAC APPLICATIONS Parent Artery Visualization

BAC APPLICATIONS Rupture Protection

BAC APPLICATIONS Balloon-Assisted Catheterization

Single lumen balloon prep

1.

Balloon

2.

Guidewire

3.

Rotating Hemostatic Valve (RHV)

4.

3-Way Stopcock

5.

3 cc Syringe

6.

1cc Syringe

7.

Saline and Contrast

Balloon Guide Catheters Cello FlowGate

CORAIL+

Cello™ Balloon Guide Catheter Product Overview Key BGC Details: – Distal balloon occludes flow and assists in aspiration – 4 sizes available: 6F+, 7F+, 8F and 9F

CelloTM Balloon Guide Catheter Ordering Information Reference Number 1610560

Product Name Cello 6F+

Conformable Sheath 7F

Tip Length (mm) 3

Balloon Length (mm) 7

OD (in)

ID (in)

0.075

1610570

Cello 7F+

8F

3

7

1610580

Cello 8F

8F

3

1610590

Cello 9F

9F

3

3

0.051

Effective Length (cm) 95

Total Length (cm) 103

0.095

0.067

95

103

10

0.102

0.075

95

103

10

0.118

0.085

92

100

Cello™ IFU – H-525 Ver. 2 August 29, 2012 and label. All images are the property of Covidien.

Cello™ Balloon Guide Catheter Inflation Tables Balloon Diameter / Recommended Balloon Volume Cello™ 6F+ BGC

Cello™ 7F+ BGC

Cello™ 8F BGC

3mm

0.02ml

-

4mm

0.04ml

4mm

0.04ml

4mm

0.04ml

4mm

0.04ml

5mm

0.07ml

5mm

0.07ml

5mm

0.08ml

5mm

0.07ml

6mm

0.11ml

6mm

0.11ml

6mm

0.12ml

6mm

0.12ml

7mm

0.18ml

7mm

0.16ml

7mm

0.17ml

7mm

1.18ml

8mm

0.26ml

8mm

0.24ml

8mm

0.25ml

8mm

0.26ml

9mm

0.34ml

9mm

0.35ml

9mm

0.36ml

Max V*

0.8 ml

-

Cello™ 9F BGC

1.0ml

-

1.0ml

1.0ml

*Inflation volumes in an unconstrained environment.

Do not inflate the balloon over 1.0mL, this is the maximum inflation volume. Inflation beyond this volume may cause the balloon to over expand and occlude the main lumen.

Image of over-inflation 4

All information from Cello™ IFU – H-525 Ver. 2 August 29, 2012 and label. All images are the property of Covidien.

Optimizing Stroke Access with a Balloon Guide Catheter A large lumen balloon guide catheter is recommended for every procedure as it appears to offer the fastest procedure times and best clinical outcomes.**

6

Recommended Procedure

Option #2

Option #3

80cm 8-9F Sheath

80cm 6F Sheath

80cm 6F Sheath

8-9F Balloon Guide Catheter

6F Catheter

5F Catheter

.021”/.027” Micro catheter

.021”/.027” Micro catheter

.021”/.027” Micro catheter

Mechanical Thrombectomy Device

Mechanical Thrombectomy Device

Mechanical Thrombectomy Device

.014” Wire

.014” Wire

.014” Wire

* Data presented by Prof. Chapot at ESMINT 2012, n=100, 50 BGC patients vs. 50 no-BGC patients.

Solitaire™ device Set-up with a BGC

Items Needed for Device Preparation (1) CelloTM balloon guide catheter (1) Dilator

(1) 1ml syringe (not included) (1) 20 ml syringe (not included) (1) 3-way stopcock (not included) (1) Beaker of 50/50 saline/contrast mix (not included)

CelloTM BGC Instructions for Use 1. Gently remove the catheter from the pouch by grasping the hub and slowly pulling the catheter straight out of the protective tubing without bending the shaft. Inspect the catheter before use to verify that its size, shape and condition are suitable for the specific procedure. 2. Prepare balloon inflation media by mixing contrast with saline (50% by volume or equivalent to 150 mg/mL iodine). 3. Fill a 20 mL syringe with 5 mL of balloon inflation media. Attach a 3-way stopcock to the balloon hub. Attach a 20 mL syringe to the stopcock.

6 4

All information from Cello™ IFU – H-525 Ver. 2 August 29, 2012 All images are the property of Covidien

1. Attach a 1 mL syringe to the balloon’s 3-way stopcock. Turn the stopcock towards the 1 mL syringe. 2. With the 20 mL syringe pointing downward: a. Pull back on the syringe plunger to aspirate the balloon lumen. Maintain negative pressure until the air bubbles stop forming in the syringe. b. Release the syringe plunger to allow media to be drawn into the balloon lumen. Do not infuse media. c. Repeat steps a and b again d. Release the syringe plunger to allow media to be drawn into the balloon lumen. Do not infuse media.

CelloTM BGC Instructions for Use Continued 6. Turn stopcock towards the balloon hub. Transfer maximum recommended balloon inflation volume from the 20 mL syringe to the 1 mL syringe. 7. Inflate the balloon up to the maximum recommended inflation volume. Refer to Table 1.Turn the stopcock off towards the balloon hub.

6. Inspect the balloon for leakage. Keep the balloon inflated until the air bubbles diffuse from the balloon. If air remains in the balloon, it should dissipate if left in a sterile field for several minutes. 7. Deflate the balloon by turning stopcock towards the 1 mL syringe and aspirating with the 20 mL syringe. 8. After ensuring that the balloon is fully deflated, wet the distal shaft with saline and insert the balloon portion of the catheter into the inserter.

6 5

All information from Cello™ IFU – H-525 Ver. 2 August 29, 2012 All images are the property of Covidien

Balloon Guide Catheter Competitive Measurements 6F

7F

8F

9F

Cello™ BGC

Merci™* BGC

Cello™ BGC

Merci™* BGC

Cello™ BGC

Merci™* BGC

Cello™ BGC

Merci™* BGC

Effective Length (cm)

95

NA

95

95

95

95 & 80

92

95 & 80

Max OD Profile (in)

0.075

NA

0.095

0.091

0.102

0.105

0.118

0.118

ID Profile (in)

0.051

NA

0.067

0.059

0.075

0.078

0.085

0.085

Max Recommended Balloon Inflation

0.26mL

NA

0.34mL

0.2 0.6mL

0.35mL

0.2 0.6mL

0.36mL

0.2 0.6mL

Balloon Diameter at Recommended Inflation Level

8mm

NA

9mm

spec not listed

9mm

Max Balloon Inflation Volume

0.8mL

NA

1.0mL

0.6mL

1.0mL

0.6mL

1.0mL

0.6mL

Balloon Length

7mm

NA

7mm

10mm

10mm

10mm

10mm

10mm

2

NA

2

1

2

1

2

1

Yes

NA

Yes

No

Yes

No

Yes

No

# Marker Bands Dual Braided

spec not listed

9mm

spec not listed

BGC Dimension Measurements 6F+ Cello™ Catheter: OD – 0.075”, ID – 0.051" Product

OD

Clearance

Neuron™* 3.5F Catheter

0.045"

0.006"

Neuron™* 5F Catheter

0.066"

-0.015”

Neuron™* 6F Catheter

0.080"

-0.029”

Penumbra™* 026 Catheter

0.051"

0.000”

Penumbra™* 036 Catheter

0.054"

-0.003”

Penumbra™* 041 Catheter

0.054"

-0.003”

Penumbra™* 054 Catheter

0.080"

-0.029”

Concentric DAC™* 4.3F Catheter

0.056"

-0.005”

Concentric DAC™* 5.2F Catheter

0.068"

-0.017”

Navien™ 058 Catheter

0.070"

-0.019”

Navien™ 072 Catheter

0.084"

-0.033”

Orion™ Micro Catheter

0.021”

0.030"

Rebar™ 18 Micro Catheter

0.021"

0.030"

Rebar™ 027 Micro Catheter

0.027"

0.024"

CelloTM BGC Dimension Measurements 7F+ Cello™ Catheter: OD – 0.095”, ID – 0.067"

6 8

Product

OD

Clearance

Neuron™* 3.5F Catheter

0.045"

0.022"

Neuron™* 5F Catheter

0.066"

0.001”

Neuron™* 6F Catheter

0.080"

-0.013”

Penumbra™* 026 Catheter

0.051"

0.016”

Penumbra™* 036 Catheter

0.054"

0.013”

Penumbra™* 041 Catheter

0.054"

0.013”

Penumbra™* 054 Catheter

0.080"

-0.013”

Concentric DAC™* 4.3F Catheter

0.056"

0.011”

Concentric DAC™* 5.2F Catheter

0.068"

-0.001”

Navien™ 058 Catheter

0.070"

-0.003”

Navien™ 072 Catheter

0.084"

-0.017”

Orion™ Micro Catheter

0.021”

0.046"

Rebar™ 18 Micro Catheter

0.021"

0.046"

Rebar™ 027 Micro Catheter

0.027"

0.040"

Information from Cello™ IFU – H-525 Ver. 2 August 29, 2012 and label. Competitive dimensions sourced from respective product IFU and labels.

BGC Dimension Measurements 8F Cello™ Catheter: OD – 0.102”, ID – 0.075"

6 9

Product

OD

Clearance

Neuron™* 3.5F Catheter

0.045"

0.030"

Neuron™* 5F Catheter

0.066"

0.009"

Neuron™* 6F Catheter

0.080"

-0.005”

Penumbra™* 026 Catheter

0.051"

0.024"

Penumbra™* 036 Catheter

0.054"

0.021"

Penumbra™* 041 Catheter

0.054"

0.021"

Penumbra™* 054 Catheter

0.080"

-0.005”

Concentric DAC™* 4.3F Catheter

0.056"

0.019"

Concentric DAC™* 5.2F Catheter

0.068"

0.007"

Navien™ 058 Catheter

0.070"

0.005”

Navien™ 072 Catheter

0.084"

-0.009”

Orion™ Micro Catheter

0.021”

0.054"

Rebar™ 18 Micro Catheter

0.021"

0.054"

Rebar™ 027 Micro Catheter

0.027"

0.048"

Information from Cello™ IFU – H-525 Ver. 2 August 29, 2012 and label. Competitive dimensions sourced from respective product IFU and labels.

BGC Dimension Measurements 9F Cello™ Catheter: OD – 0.118”, ID – 0.085"

7 0

Product

OD

Clearance

Neuron™* 3.5F Catheter

0.045"

0.040"

Neuron™* 5F Catheter

0.066"

0.019"

Neuron™* 6F Catheter

0.080"

0.005“

Penumbra™* 026 Catheter

0.051"

0.034"

Penumbra™* 036 Catheter

0.054"

0.031"

Penumbra™* 041 Catheter

0.054"

0.031"

Penumbra™* 054 Catheter

0.080"

0.005"

Concentric DAC™* 4.3F Catheter

0.056"

0.029"

Concentric DAC™* 5.2F Catheter

0.068"

0.007"

Navien™ 058 Catheter

0.070"

0.015”

Navien™ 072 Catheter

0.084"

0.001”

Orion™ Micro Catheter

0.021”

0.064"

Rebar™ 18 Micro Catheter

0.021"

0.064"

Rebar™ 027 Micro Catheter

0.027"

0.058"

Information from Cello™ IFU – H-525 Ver. 2 August 29, 2012 and label. Competitive dimensions sourced from respective product IFU and labels.

Catheter Construction •

Stainless steel double braid throughout provides stability and pushability



5 transition zones • Smooth transition from proximal support to distal flexibility • Improves kink resistance

Catheter Construction •

Co-axial lumen with fast inflation and deflation



Slight decrease in OD beneath the balloon allows the balloon to be flush mounted



Holes in outer jacket allow for inflating and deflating the balloon

Outer Jacket

Inner Shaft

Inflation Lumen

Balloon Construction •

Compliant 10mm diameter and length balloon at maximum infusion volume – designed to conform to the vessel wall



Gas-permeable – air bubbles will diffuse out of the balloon during prep



Provides proximal flow control Deflated, the balloon is flush with the outer jacket

There is a slight decrease in outer jacket beneath the balloon to allow the balloon to be flush-mounted to the shaft.

Hub Construction

Reference number

Description

Length

OD

ID

90485

FlowGate² 8F Balloon Guide Catheter

85cm

8F (2.7mm, 0.10in)

0.084in (6.4F, 2.13mm)

90495

FlowGate² 8F Balloon Guide Catheter

95cm

8F (2.7mm, 0.10in)

0.084in (6.4F, 2.13mm)

Features and Benefits Success Accelerated •

Largest 8F BGC lumen for clot capture and Trevo system compatibility



Optimized combination of trackability and support



Proximal flow control correlates with better procedural, angiographic and clinical outcomes

FlowGate² : 0.084in Merci® : 0.078in Cello 8F : 0.075in

Indications CORAIL+

Guiding catheters with distal tip balloon

For occlusion test of the Carotid artery

To reverse the flow in the Carotid artery before stenting For blockage of flow during carotid angioplasty

For placement of all thrombectomy devices

Features & Benefits FEATURES CORAIL+

BENEFITS

Double-lumen catheter No hydrophilic treatment

Compliant balloon

MAXIMIZED STABILITY &

BEST NAVIGABILITY Inner-braiding Distal soft & flexible part  9mm Balloon size  inflatable up to 12mm Catheter’s tip of the balloon in the middle

Compatible with most microcatheters & thrombectomy devices Large inner lumen  up to .074’’ 3 references

COMPLETE OCCLUSION (CCA & ICA) BETTER COAXIAL ARRANGEMENT

HIGH COMPATIBILITY ASPIRATION POWER DEVELOPED PORTFOLIO

Compatibilities COMPATIBILITY CORAIL6F+

Large microcatheters (VASCO+) and with most thrombectomy devices

CORAIL8F+

- Aspiration catheters - Microcatheters used for thrombectomy - Carotid stent up to 7mm

CORAIL8F+L For extra distal access (petrosal ICA) T30 Distal tip can be steam shaped

Indeed, thanks to its long shapeable, flexible & atraumatic distal tip (30mm) the CORAIL8F+LT30 enables us to reach further away segments (extra distal access).

Global range Max balloon volume

N° of RX markers

Ø ID

Ø OD

CORAIL6F+

1,20mm (.047’’)

6F

9cm

100cm

11 x 12

1,20mL

1 distal to the balloon

CORAIL8F+

1,89mm (.074’’)

8F

9cm

100cm

12 x 12

1,20mL

1 distal to the balloon

CORAIL8F+LT30

1,89mm (.074’’)

8F

12cm

110cm

12 x 12

1,20mL

1 distal to the long tip

REFERENCE

CORAIL+

Total length

Inflated balloon 1mL Ø x L (mm)

Supple part lenght

CORAIL8F+LT30  mandrel to steam shaped the distal tip (30mm)