1. Overview of Balloon Catheter
Sameer Gupta, MD Interventional Cardiologist & Endovascular Interventionalist Metro Group of Hospitals Noida, UP
Diplomate American Board of Internal Medicine – Medicine
Diplomate American Board of Internal Medicine – Cardiovascular Disease
Diplomate American Board of Internal Medicine – Interventional Cardiology
Diplomate National Board of Echocardiography-- (USA)
Diplomate American Board of Vascular Medicine – Endovascular Intervention

2. Evolution of PTCA
The balloon catheter was first used to perform PTCA in 1977,
which led to many subsequent advances in the field of interventional cardiology.
1977
Beginning of Angioplasty Era
• 40+% re-narrowing
• 10% abrupt closure
1994
1929
1977
Beginning of the Stent Era
1964
Dr. Werner
Dr. Andreas
• 20+% restenosis
Dr. Charles Dotter
Forssmann
Gruntzig
performed the 1st
accessed the heart
performed the 1st
peripheral
from the
percutaneous
angioplasty.
peripheral
transluminal
circulation using
coronary
2002
a catheter
angioplasty (PTCA)
Beginning of the DES Era
• <10% restenosis
Not

3. Plain ‘old’ balloon angioplasty
A balloon catheter, or angioplasty balloon, is a small tube which has a balloon mounted at the distal end.
Angioplasty Balloon Catheter consists of
The balloon is inflated
2 Integrated parts:
and deflated using an
inflation device.
1. The balloon to dilate the lesion
2. The catheter to deliver the balloon to the lesion
Not

4. Balloon : Clinical Needs
Deliverability, crossability and dilatation are clinical needs addressed by balloon dilatation catheters.
Deliverability – Must
reach the target
Deliverability
Crossability
Crossability – Must pass
Balloon Catheter
through the target lesion/
Differentiators
stent multiple times if
needed
Dilatation – Must safely
Dilatation
open the target
Not

5. Clinical Needs  Design Goals
Clinical needs identify product attributes, which are converted to specific product design goals.
Clinical Needs
Product Attributes
Sample Design Goals
Kink Resistant
1:1 Response
Pushability
OTW vs RX
Low Profile
Trackability
Flexible
Lubricious
Small tip OD
Low profile transition angles
Lesion Entry Profile
Flexible tip
Tight wrap
Crossing Profile
Low profile marker bands
Thin balloon material
Wrap/Rewrap
Tight wrap orientation
Tight rewrap memory
High rated burst pressure
Low longitudinal and radial growth
Radial Force
Distinct shoulders
Clearly defined working length
Positioning
Minimal balloon movement
Consistent nominal pressure
Sizing
Repeatable controlled growth
Broad size matrix
Inflation
Consistent inflation/deflation
Quick deflation
Predictable balloon burst
Not

6. Dilatation
Not

7. Overview of Balloon Catheters
Compliance
The ability of a balloon material to increase in size or stretch as the pressure is increased
Determined by
The balloon’s diameter growth over a range of inflation pressures
Presenter
Compliance is defined as the ability of the balloon material to increase in size or stretch as pressure is increased. The type of balloon material determines compliance.
Relative compliance of balloon materials can be determined over a range of pressure—ATMs—using this simple formula, which often is stated as a percentage.
Presenter Note: Read the formula to the audience.
Formula: Compliance (%) =
High ATM — Low ATM
Low ATM
(x 100%)

8. Dilatation : Types of Balloons
Growth is more significant as pressure increases
Balloons grow in areas of least resistance
Growth is more significant as pressure increases
Balloons grow in areas of least resistance
Presenter:
Click on image to run video
Low and focal growth as pressure increases
Designed for dilatation of calcified or resistant lesions

9. Materials & Performance
Compliance
Dilatation force
Presenter
When talking about balloon materials and performance, we need to consider compliance and dilatation force.
First, let’s talk about compliance.

10. Radial Force : Balloon Compliance
Compliance is the ability of a balloon to grow with pressure.
• Semi-compliant balloons grow and conform
to the areas of least resistance as pressure
Semi-Compliant
is increased
– Semi-compliant balloon actually grows more
where it is not constricted, thus having a
higher potential for causing edge dissections.
“Dog bone” effect
– ↑ pressure = ↑ size
• Non-compliant balloons grow and conform
less as pressure is increased
Non-Compliant
– Little change in volume with incremental
increases in pressure. More force is exerted
against a lesion at a given inflation pressure
than SC balloons, including stent delivery
balloons.
– ↑pressure = ↑ rigidity
Romagnoli et al JACC 2008
Not

11. Radial Force : Balloon Growth
With an increase in pressure, a semi-compliant balloon will experience a greater amount
of diameter growth versus a non-compliant balloon at same pressure.
• Semi-Compliant = ~8-10% growth within the working range when inflated
• Non-Compliant = ~4-6% growth within the working range when inflated
Pressure
Semi
Non
(atm)
Compliant
Compliant 4
2.65
2.69
Compliance Comparison
(3.0 mm balloon) 5
2.75
2.76 6
2.87
2.82
3.4 7
2.94
2.88 SC NC
3.2 8
3.00
2.93 9
3.06
2.97 3 10
3.10
3.00
Diameter
2.8 11
3.15
3.02
2.6 12
3.18
3.05 13
3.23
3.07
2.4 14
3.27
3.10 6 8 10 12 14 16 18 15
3.12
Pressure (ATM) 16
3.15 17
3.17 18
3.20
Blue indicates nominal pressure.
Baim, D. Grossman’s Cardiac Catherization, Angiography and Intervention.
Red indicates rate of burst pressure.
Philadephia:Lippincott Williams & Wilkins
Not

12. High to moderate compliance balloons
Polyolefin copolymer (POC)
Polyethylene (PE) [< than POC]
Balloon sizing important – oversizing can easily occur
Tend not only to stretch in D but also to overexpand into the areas of least resistance, i.e. prox & distal to lesion –(‘dog-boning’)- dissection observed more commonly
Crossability may be superior

13. Semi Compliant Balloon : When & Why ?
Primary use for semi-compliant balloons is pre-dilatation of a stenotic portion of a coronary artery.
• 80% of PCI procedures use a semi-compliant balloon for:
– POBA
– Pre-dilatation:
• Accurately size lesion
• Allows better access to the lesion
– When unable to direct stent
– More difficult cases, such as ultra tight lesions or
bifurcations
• Features of a semi-compliant balloon:
– Softer material = better trackability (great for difficult to reach/treat lesions)
– Expands in size as pressure is increased: provide sizing flexibility (8–10% growth rate)
– Offers good re-wrap (helpful when multiple inflations are required)
– Nominal of 6/8 atm, RBP of 12/14 atm
• Working range of 6–12 atms for smaller balloons
• Working range of 8–14 atms for workhorse balloons
Not

14. Non complaint balloons
Polyethylene terephthalate (PET)
thicker-walled balloon
Allow work at higher pressures
hard calcified lesion or post-stent dilatation

15. Non Compliant Balloon – When & Why ?
One of the major uses for a non-compliant balloon is post-dilatation of a delivered sent.
• 20% of PCI procedures use a non-compliant balloon for:
– ‘Crack’ highly calcified lesions
– Post dilatation:
• Minimal longitudinal growth is key to avoid dilating
outside the stented area
– Increasingly important in era of DES for reducing
likelihood of:
• Mal-apposed stent struts
• Edge effect restenosis
• Features of a non-compliant balloon:
– Stiffer, more durable material = withstands/delivers higher pressure (great for “tough to crack” lesions)
– Less trackable through vasculature
– Minimal size expansion as pressure is increased: ideal for focused dilatation (4-6% growth rate)
– Typically offers poor re-wrap
– Nominal of 10–12 atm, RBP of 18–20 atm (ideal for post dilatation)
Not

16. Compliance Charts Balloon Compliance Compliant Semi-Compliant
Diameter (mm)
Presenter
This chart illustrates the different types of balloon materials and their relative growth as pressure increases.
Non-Compliant
Atmospheres (ATM)

17. (a) A compliant balloon tends to be oversized at the edges, with less dilatation at the obstructive segment of the lesion (‘dog-boning’)
(b) A noncompliant balloon gives a predictable amount of pressure at the lesion without uncontrolled radial and longitudinal growth

18. Dilatation Force Dilatation force
The radial force exerted by the balloon on the coronary lesion or metal stent
Dilatation force is a function of
Inflation pressure
Balloon material (compliance)
Presenter
Dilatation force is the radial force exerted by the balloon on the coronary lesion or metal stent. Dilatation force is a combined measure of:
Inflation Pressure: The pressure applied to inflate the balloon.
Balloon Material: A more compliant balloon material results in reduced dilatation force at the lesion. More non-compliant balloon material provides greater dilatation force at the lesion.

19. Overview of Balloon Catheters
Compliance
Nominal pressure
Rated burst pressure
Working range
Dilatation force
Presenter
When talking about balloon materials and performance, we need to consider compliance and dilatation force.
First, let’s talk about compliance.

20. Compliance : Nominal Pressure
Compliance Chart
Compliance
Nominal pressure
The amount of pressure in ATM required to inflate the balloon to its labeled diameter
3.0mm Balloon
Presenter
Nominal pressure is the amount of pressure in ATMs required to inflate the balloon to its labeled diameter.
Example:
A 3.0 mm balloon with nominal pressure of 6, should reach a 3.0 mm diameter when 6 ATMs of pressure is applied

21. Compliance : Rated Burst Pressure
Compliance Chart
Compliance
Rated burst pressure :
The pressure level (ATM) a balloon is designed to accept without rupture
3.0mm Balloon
Presenter
Rated Burst Pressure (RBP) is based on the results of in vitro testing. Generally, at least 99.9 percent of the balloons (with a 95 percent confidence) will not burst at or below their rated burst pressure.
Use of a pressure monitoring device is recommended to prevent over pressurization. The manufacturer recommends that balloon pressure should not exceed the RBP. The rated burst pressure is based on the results of in vitro testing. Generally, at least 99.9 percent of the balloons (with 95 percent confidence), will not burst at or below their rated burst pressure. Use of a pressure monitoring device is recommended to prevent over-pressurization.
Example:
A balloon with RBP of 14 is designed to accept 14 ATMs of pressure without failure

22. Compliance : Working Range
Compliance Chart
3.0mm Balloon
Compliance
Working range
The inflation range (ATM) between nominal and rated burst pressure
Working range = RBP - nominal pressure
Presenter
On the compliance chart shown here, the working range is between 6 and 14 ATMs of pressure.

23. Rated Burst Pressure RATED BURST PRESSURE
Working Range is the inflation range (atm) between nominal and rated burst pressure.
RATED BURST PRESSURE
• Is the Maximum pressure to which a balloon is designed to be inflated
– 95% confidence that 99.9% will not fail at or below rated burst
• Working Range is the inflation range (atm) between nominal and rated burst pressure
– Typically 8 – 14 atm for SC balloons
– Typically atm for NC balloons
Not

24. Balloon Inflation : Goal
For optimal function the balloon should have predictable, consistent
inflation and deflation times as well as a predictable rated burst pressure.
INFLATION
• Inflation: increasing balloon pressure and size or volume
– Typically refers to the change from wrapped configuration to nominal size
• Deflation: changing from nominal configuration to wrapped
– Typically takes 20─30 seconds for full balloon deflation
– Should be confirmed fluoroscopically by absence of contrast in the balloon
• Inflation/deflation is influenced balloon volume and pressure and the cross-functional
area of the deflation lumen (larger area = faster inflation/deflation)
Not

25. Balloon Sizing : Radial & Longitudinal Growth
Growth refers to change in size (either radially or longitudinally) per atm of pressure applied.
Radial Growth – amount the
balloon grows radially as
pressure is applied
Longitudinal Growth:
amount the balloon grows
longitudinally
as pressure is applied
Balloon growth may influence stent elongation during deployment.*
*Domei et al. ESC 2013
Not

26. Balloon Sizing ─ Size Matrix
Balloons size matrix is dictated by clinical needs and may
include 6─40 mm length and 1.00─5.00 mm diameter balloons.
Lengths (mm)
Diameter
(mm) 6
8/9 10 12
14/15
20/21
25/27 30 40
1.00
1.20/1.25
1.50
2.00
2.25
2.50
2.75
3.00
3.25
3.50
3.75
4.00
4.50/5.00
Not

27. SC and NC Balloon Summary
SC balloons are typically used for POBA or pre-dilatation pre-dilation, particularly in ultra tight lesions.
NC balloons are reserved for calcified lesions and post dilatation, where high pressure is needed.
POBA of
Pre-dilatation
Pre-dilatation
POBA of
Pre-dilatation
High pressure
non-calcified
of non-calcified
of ultra tight
calcified
of calcified
post-dilatation
lesions
lesions
lesions
lesions
lesions
of a stent
Semi-
Compliant
(SC)
Non-
Compliant
(NC)
Romagnoli et al, Drug-Eluting Stenting: The Case for Post-Dilation, J. Am. Coll. Cardiol. Intv. 2008;1;22-31
Lui, H, The Perfect Fit: Getting the Most Out of Your Coronary Stent, Cath Lab Digest, October 2005
Not

28. Balloon Rupture : Patterns
In case of failure, the ability of a balloon to split along a seam, rather than
a pin hole, may help minimize balloon material embolization.
Pinhole Rupture
• High pressure jet of contrast forced through pinhole
and directed at vessel wall
Circumferential (Radial) Rupture
• Balloon separates into two halves
Longitudinal (Axial) Tear
• Balloon ruptures in a clean tear along the length of
the balloon (desired failure mode, if a burst occurs.
Minimizes risk of vessel injury or component detachment
Parikh 2012
Not

29. Materials & Performance
Dilatation force
Pressure vs force
High pressure ≠ dilatation force/non-compliance
High Pressure
The ability of the balloon to operate at higher thresholds
Compliance
The rate of the change in balloon diameter over a range of inflation pressures
Presenter
A high pressure balloon does not necessarily mean the balloon is non-compliant or that it will provide higher dilatation force to the lesion. The compliance chart provided with the balloon catheter needs to be evaluated to determine if the balloon has compliant or non-compliant performance characteristics and what type of dilatation force it will provide to the lesion.
Compliant balloons can be generally expanded an additional 10 to 20 percent over their listed diameter when high inflation pressures are applied. However, these balloons do not hold their shape and can grow longitudinally, expanding outside the point of resistance. The result is less dilatation force being exerted at the lesion and an increased risk of dog-boning and potential vessel dissections.
Non-compliant balloons are made of a special material that provides limited growth over a high range of pressures. Because the balloon does not grow as much, it can exert much more focal force at the lesion site. Lesions are appropriately treated with this type of balloon material when maximum dilatation forces are needed. A lesion with hard, resistant plaque or post-dilatation of a stent are two examples of common usages of non-compliant balloons.

30. Compliant and Semi-complaint Balloons
Better flexibility & trackability
Better cross and recross performance
Limited durability
Increased diameter and longitudinal growth variance
Limited dilatation force
Compliant & Semi-compliant Balloons
Presenter
Because the compliant balloon is softer and more flexible, it has the ability to more easily traverse through the twists and turns of difficult anatomy.
The thin compliant material is also able to cross difficult or tight lesions because of these soft, flexible traits.
The soft, flexible material however, limits the balloon’s durability and allows for greater variance in diameter and longitudinal growth.

31. Balloon Attributes that affect Dilatation
The final action a balloon must successfully perform is to open the target lesion.
Balloon radial force, positioning, sizing and inflation all determine how effectively this happens.
Clinical Needs
Product Attributes
Sample Design Goals
High rated burst pressure
Low longitudinal and
Radial Force
radial growth
Distinct shoulders
Clearly defined working
Positioning
length Minimal
balloon movement
Consistent nominal
pressure Repeatable
Sizing
controlled growth
Broad size matrix
Consistent
inflation/deflation
Inflation
Quick deflation
Predictable balloon burst
Not

32. Balloon Sizing : Design Goals
For accurate balloon sizing, the balloon must be available in a broad size matrix,
have consistent nominal pressures and exhibit repeatable and controlled balloon growth.
BALLOON SIZING
• Refers to the length and diameter dimensions of the deployed balloon.
• Accurate balloon sizing is influenced by nominal pressure, balloon growth and
size matrix. It is also influenced by operator selecting the correct catheter size
and deploying to the correct pressure according to the compliance label.
• To maximize balloon sizing, balloon should focus on:
– Consistent nominal pressure
– Repeatable/controlled growth
– ↑ size matrix
Not

33. Balloon Sizing : Nominal Size and Pressure
Nominal size and pressure identifies the diameter and length balloons should reach when inflated.
Nominal Size – stated diameter and length a
balloon should reach at nominal pressure
• Balloons are typically labeled based on their
nominal size, for example a 3.0 x 20 balloon is
a 3 mm diameter balloon with a working length
of 20 mm
Nominal Pressure (NP): pressure at which the
balloon reaches the labeled size/diameter
• Typical NP for NC balloons: 12 atm
• Typical NP for SC balloons: 8 atm
• Minimum deviation should exist between the
size at nominal pressure and labeled product size,
regardless of the # of inflations
Not

34. Balloon Positioning ─ Design Goals
For accurate positioning, the balloon must have a clearly defined working length,
distinct balloon shoulders and exhibit minimal movement either during or after inflation.
BALLOON POSITIONING
• Refers to precise placement of the inflated balloon at the target site.
• Accurate balloon positioning is influenced by its working length, balloon shoulders
and balloon movement during or after inflation.
• To maximize balloon positioning, balloon design should include:
– ↑ visible marker bands: radiopaque markers placed at the distal and proximal edge of the
working length
– Distinct balloon shoulders: Balloon blowing process
– ↓ balloon movement: (See slide 59 for details)
Not

35. Balloon : Working Length & Taper
Precise balloon positioning ensures lesion coverage, with minimal damage to adjacent healthy tissue.
Working length: The balloon
surface in contact with the tissue
when inflated; should be the
distance between distal and
Inflated
Diameter
proximal marker bands
Working Length
Cone Angle/Balloon Taper:
Angles of the balloon cones
and length of tapers
Steep transitions deliver focal dilatation
and minimize risk of edge dissections1
1. Parikh 2012
Image shows NC balloon 3.0 mm at 12atm
Not

36. Balloon Positioning WATERMELON SEEDING •
Watermelon seeding is the tendency of a balloon to slip within a lesion when inflated.
WATERMELON SEEDING •
More common with short balloons •
Can be minimized by selective or “candy cane” coating •
In ISR lesions, scoring or gripping balloons can also minimize balloon slipping •
Operator dependent. Minimize movement by selecting longer balloons (which may
not always be possible based on the lesion being treated) and slower inflation.
Hydrophilic or silicone coating on balloon helps track, but may make balloon more
prone to slippage.
Not

37. Average deflation time of PTCA balloon catheters

38. Radial Force : Design Goals
Maximum radial force should be achieved without risk to vessel distal and proximal to the lesion/stent.
RADIAL FORCE
• Is the force exerted in a radial direction on the lesion and
More Compliant
vessel wall by an inflated balloon.
• Is influenced by compliance and pressure.
• To optimize radial force, balloon design should focus on:
– ↑ rated burst pressure
MATERIAL
– ↓ longitudinal/radial growth
Less Compliant
Not

39. Deliverability
Not

40. Balloon Attributes that Impact Deliverability
The 1st thing a balloon must successfully do is get to the lesion.
Catheter pushability and trackability determine how easily it can get there.
Clinical Needs
Product Attributes
Sample Design Goals
Kink Resistant
Pushability
1:1 Response
OTW vs RX
Low Profile
Trackability
Flexible
Lubricious
Not

41. Balloon Attributes that Impact Deliverability
There are two types of delivery systems : Over the Wire (OTW) and Rapid Exchange (RX or Monorail).
The difference between the two is how much of the guide wire is incorporated into the catheter shaft.
Over-the-Wire
Inflation Port
Guidewire
Inflation lumen
and guidewire lumen
Rapid Exchange
Guidewire
Inflation port
Inflation lumen
Inflation lumen only
and guidewire lumen
Not

42. Pushability – Wire Compatibility
OTW provides continuous guide wire support, resulting in greater pushability. This type of system
is ideal for more difficult cases, where greater push and wire exchanges may be needed.
Advantages
Disadvantages
Specific Uses
• Continuous guidewire support
• Long 300 cm wire necessary (or
• Treatment of complex lesions
wire extension for 180 cm wires)
where the following may
• Greater push for distal anatomy
be required:
• 2nd operator usually required
• Wire exchange during
— Added wire support
difficult cases through lumen
• May be associated with
— Easy exchange of wires
longer procedure
— Extra catheter pushability
— Intracoronary injections
Not

43. Rapid Exchange (Rx) Delivery System
RX provides good wire control and quick catheter exchanges, allowing single operator technique.
This type of system is ideal for simpler cases, where the extra wire support is not needed.
Guidewire
Advantages
Disadvantages
Specific Uses
• Quick balloon exchanges
• Inability to exchange wires w/o
• Cases, where extra support is
removing the entire system
not required
• Requires only a single operator
• Inability to switch to an
• Greater operator control
OTW system w/o exchanging
of wire
the guidewire
• Less fluoro and
• Reduced pushability
procedural time
Not

44. Pushability ─ Design Goals
To increase balloon catheter pushability, the catheter shaft should be kink resistant,
have 1:1 response and be OTW compatible.
PUSHABILITY
• Is the transmission of a forward push force from the catheter’s proximal end to its
distal end
• Is influenced by the shaft column strength, kink resistance, and wire compatibility.
• To maximize pushability, balloon catheter design should focus on:
– ↑ Shaft Column strength
– ↑ Kink resistance: material and manufacturing process
– ↑ 1:1 response
– ↑ Wire compatibility: OTW design provides more pushability
Not

45. Trackability : Design Goals
Unibody Balloons
To increase balloon catheter trackability, the balloon catheter should be
low profile, flexible and have a lubricious coating.
TRACKABILITY
• The ease with which the balloon catheter follows over the guidewire through the
coronary anatomy from point A to point B.
• Is influenced by friction (within wire lumen and outer surface), catheter profile
and catheter flexibility.
• To maximize trackability, balloon catheter design should focus on:
– ↓ Low Profile: manufacturing process
– ↑ Flexibility: material
– ↑ Lubricity: hydrophilic coating decreases friction/resistance
Not

46. Crossability
Not

47. Balloon Attributes That Impact Crossability
The 2nd thing a balloon must successfully do is cross the lesion.
Lesion entry/crossing profile and wrap/rewrap all determine how easily this happens.
Clinical Needs
Product Attributes
Sample Design Goals
Small tip OD
Lesion Entry Profile
Low profile transition
angles Flexible tip
Tight wrap
Crossing Profile
Low profile
marker bands
Thin balloon material
Wrap/Rewrap
Tight wrap orientation
Tight rewrap memory
Not

48. Balloon Profiles Balloon Profiles Lesion Entry Profile = Distal Tip
The lesion entry and crossing profiles of the balloon are going to have a
direct impact on a balloon’s ability to cross the lesion.
Most balloons have a proximal and distal marker band
Lesion
Proximal
Proximal
Crossing
0.014”
Entry
Shaft
Bond
Profile
wire
Small (1.25 mm) balloons have one, mid balloon marker band
Profile
Lesion Entry Profile = Distal Tip
Crossing Profile = Distal Bond
• First point at which the balloon catheter comes
• Where the balloon material is bonded to the tip
into contact with a lesion
of the catheter
• Usually one of the largest diameters on the distal
segment of the balloon catheter
Not

49. Lesion Entry Profiles : Design Goals
To decrease the balloon catheter lesion entry profile, the catheter tip
should be flexible and have a small outer diameter.
LESION ENTRY PROFILE
• Is the outer diameter and shape of the catheter’s distal tip and is the first point at
which the balloon catheter comes into contact with a lesion.
• Is influenced by the tip diameter and flexibility
• To minimize/optimize the lesion entry profile, balloon design should focus on:
– ↓ tip diameter
– ↑ tip flexibility
– Smooth tip taper
Not

50. Lesion Entry Profiles : Design Goals
To decrease the balloon catheter crossing profile, the catheter
should have low profile marker bands and balloon bond.
CROSSING PROFILE
• Is the largest incompressible profile on the distal catheter which must cross the lesion.
• Is influenced by the balloon bond and marker bands.
• To minimize/optimize the crossing profile, balloon catheter design should focus on:
– ↓ balloon profile
– ↓ profile marker bands
– ↓ profile distal balloon bond (or tip seal)
Not

51. Wrap : Design Goals WRAP
To decrease the balloon wrap profile, the balloon should be made of
thin material wrapped as tightly as possible around the catheter.
WRAP
• Refers to the tightness of the balloon material that is wrapped around the shaft of
the balloon delivery system when originally manufactured.
• Is influenced by the wrapping technique, fold orientation (i.e. #folds) as well as the
balloon material.
• To minimize/optimize the wrap profile, balloon design should focus on:
– ↑ wrap tightness
– Balloon material
– # of folds
Not

52. Re Wrap : Design Goals RE-WRAP
To decrease the balloon re-wrap profile, the balloon should be made of
thin material wrapped as tightly as possible around the catheter.
RE-WRAP
• Refers to the way the balloon returns to its original wrapped state after being inflated
and deflated.
• Is influenced by many factors, including the original wrapping technique and
orientation, the balloon material and memory, as well as the inflation pressure
and number of repeated inflations.
• To minimize/optimize the re-wrap profile, balloon catheter design should focus on:
– Balloon material
– Tight original wrap process
Flat
Trifold
Not

53. Workhorse Balloons (Semi-Compliant)
Many Semi-Compliant balloons are available varying in design, length and diameter.
Falcon Grande
Sprinter Legend
Ryujin Plus*
Tazuna*
Tin®*
Filao*
Everest*
(Medtronic)
(Medtronic)
(Terumo)
(Terumo)
(SIS-Medical)
(Natec Medical)
(Blue Medical)
Tip entry
profile
N/A
0.016
0.017
0.016
0.017
0.017
0.016
3.00mm
Crossing
N/A
0.020
0.024
N/A
N/A
N/A
N/A
Profile (in) +
Catheter RX RX
RX and OTW RX
N/A
RX and OTW RX
design
Diameter
4.50 – 7.00
1.25 – 4.00
1.50 – 4.00
1.50 – 3.00
1.50 – 4.50
1.50 – 4.50
2.0 – 4.0
(mm)
6, 10, 12, 15, 20,
10, 12, 15, 17, 20,
8 to 41 mm (1mm
Length (mm)
14, 20, 30, 40
25, 30
10, 15, 20, 30, 40
10,15, 20 22
step)
10,15,20, 30
Usable
140 (RX) / 137
140
142
145
145
N/A
154
shaft length
(OTW)
Balloon
material
FLEXITEC™HS
Fulcrum
N/A
N/A
N/A
Polyn®
Polyamide
Selective
Coating
LFC hydrophilic
Hydrophilic
Hydrophilic
N/A
Hydrophilic
Hydrophilic
DuraTrac
2.7 distal,
Shaft
3.5 distal,
2.4 / 2.6 distal,
2.4 – 2.6 distal,
distal
1.95 prox. (RX) 2.7
2.4 distal,
diameter
2.3 prox.
1.9 prox.
2.0 prox.
N/A
1.9 prox.
distal,
1.9 prox.
3.2 prox. (OTW)
1.50mm Single
1.50mm Single
Single and
Marker
Single and Double
N/A
N/A
N/A
> 1.5 Double
2.00 – 4.00 Double
Double
*From manufacturer’s published literature unless otherwise specified
+ Test data on file at Medtronic Inc. Bench test results may not be indicative of clinical results
Not

54. Workhorse Balloons (Semi-Compliant)
Many Semi-Compliant balloons are available varying in design, length and diameter.
Falcon Grande *
Sprinter Legend
Maverick XL
Apex
Mini-Trek & Trek*
LaCrosse*
Panterra*
(Medtronic)
(Medtronic)
(Boston)
(Boston)
(Abbott)
(Goodman)
(Biotronic)
Tip entry
profile
N/A
0.016
0.022
0.017
0.017
0.017
0.017
3.00mm
Crossing
N/A
0.020
N/A
0.024
0.025
N/A
N/A
Profile (in) +
Catheter RX RX RX
RX and OTW
RX / OTW RX RX
design
Diameter
(mm)
4.50 – 7.00
1.25 – 4.00
4.00 – 6.00
1.50 – 5.00
1.50 – 5.00
2.00 – 4.00
1.50 – 4.00
6, 10, 12, 15, 20,
Length (mm)
14, 20, 30, 40
N/A
8,12,15,20,30,40
6, 8, 12, 15, 20, 25, 30
10, 15, 20, 30
6, 10, 15, 20, 25, 30
25, 30
Usable shaft
140
142
150
140
145
143
140
length (cm)
Balloon
Semi Crystalline
material
FLEXITEC™HS
Fulcrum
DynaLEAP®
Opti™ LEAP®
Pebax
N/A
Co-Polymer
Bioslide®
hydrophilic- shaft
Supraglide
Coating
LFC hydrophilic
Hydrophilic
XTRA™ coating
Hydrocoat hydrophilic
Hydrophilic
Xtra
(Hydrophilic)
hydrophobic- balloon
1.50mm: 2.3 distal,
Shaft
3.5 distal,
2.4 /2.6 distal,
2.3 distal,
2.1 prox. (RX)
2.5 / 2.7 distal,
2.4 distal,
N/A
diameter
2.3 prox.
1.9 prox.
2.1 prox. (RX)
3:00mm: 2.4 distal,
2.2 prox. (RX)
N/A prox. (RX)
2.1 prox. (RX)
Single and
1.50mm Single
1.50 mm Single
Marker
N/A
Double
2.0 – 2.5 Single
1.50 Single
Double
> 1.5 Double
2.00 mm – 4.00 mm Double
2.0 – 4.00 Double
2.00 – 4.00 Double
*From manufacturer’s published literature unless otherwise specified
+ Test data on file at Medtronic Inc. Bench test results may not be indicative of clinical results
Not

55. Crossing Balloons
Numerous crossing balloons are available across global markets.
Filao CTO*
Falcon CTO*
Sprinter Legend+
Across CTO*
Ryujin Plus*
Tazuna*
NIC 1.1*
NIC NANO*
(Natec
Summit*
(Medtronic)
(Medtronic)
(Acrostak)
(Terumo)
(Terumo)
(SIS-Medical)
(SIS-Medical)
Medical)
(Blue Medical)
Tip entry
profile (in)
0.016
0.016
0.015
0.017
0.016
0.017
0.017
0.017
0.016
Crossing
0.025
0.020
N/A
0.022
0.022
N/A
N/A
N/A
N/A
Profile (in)+
Catheter
RX and OTW
RX and OTW
RX and OTW
RX and OTW RX
RX and OTW
RX and OTW
RX and OTW RX
design
Diameter (mm)
1.00
1.25
1.10
1.25
1.25
1.10
0.85
1.25
1.10, 1.25
RX: 10, 14, 20
RX: 6,10,12,15,20
10, 12, 15, 17,
8 to 41 mm
Length (mm)
10, 15, 20
10, 15
10,15
10, 15
10,15,20
OTW: 10, 14, 20
OTW: 6,10,15,20
20, 22
(1mm step)
Usable shaft
RX: 145
RX;142
138 (RX)/
140 (RX) / 137
length (cm)
145
145
160
160
154
OTW: 160
OTW: 152
150 (OTW)
(OTW)
Balloon
FLEXITECTM PF
XRZFT
N/A
N/A
N/A
N/A
N/A
Polyn®
Polyamide
material
Coating
LFC hydrophilic
Hydrophilic
Hydrolubic
Hydrophilic
Hydrophilic
N/A
N/A
Hydrophilic
Hydrophilic
2.2 distal,
2.4 / 2.6 distal,
2.25 distal,
2.7 distal,
1.9 prox. (RX)
1.9 prox. (RX)
1.95 prox. (RX)
Shaft
2.0 prox. (RX) 2.2
2.4 distal,
2.4 distal, 1.9
2.4 distal,
2.6 distal,
N/A
N/A
2.7 distal,
diameter (F)
distal,
2.4 / 2.6 distal,
2.0 prox.
prox.
1.9 prox.
2.8 prox.
3.2 prox.
3.3 prox. (OTW)
3.2 prox. (OTW)
(OTW)
(OTW)
Single and
Marker
Single
Single
Single
Single
Single
Single / Proximal
N/A
N/A
Double
*From manufacturer’s published literature unless otherwise specified
+ Test data on file at Medtronic Inc. Bench test results may not be indicative of clinical results
Not

56. Crossing Balloons
Numerous crossing balloons are available in various across global markets today.
Apex*
Tapered
Nimbus
SapphireII*
Falcon CTO*
Sprinter Legend+
Push/Flex
Mini-Trek*
LaCrosse*
EzeCTO*
Pico µ*
Panterra*
(Orbus
(Medtronic)
(Medtronic)
(Boston)
(Abbott)
(Goodman)
(Clearstream)
(ClearStream)
(Biotronic)
Neich)
Tip entry
0.016
0.016
0.017+
0.017
0.017
0.017
0.017
0.017
N/A
profile (in)
Crossing
0.025
0.020
0.024
0.023
0.024
N/A
N/A
N/A
N/A
Profile (in)+
Catheter
RX and OTW
RX and OTW
RX/OTW
RX / OTW RX
RX / OTW RX RX RX
design
Diameter (mm)
1.00
1.25
1.50
1.20
1.30
1.25
1.25
1.25
1.00, 1.25
RX: 10, 14, 20
RX: 6,10,12,15,20
6, 8, 12, 15,
9, 12,15, 20, 30,
5, 8, 10, 12,
Length (mm)
8, 12, 15, 20 10 15
6, 10, 15, 20
OTW: 10, 14, 20
OTW: 6,10,15,20 20 40 15
Usable shaft
RX:145;
RX;142
138 (RX); 148
143
145
143
138
140
140 and 150
length (cm)
OTW: 160
OTW: 152
(OTW)
Semi
Balloon
FLEXITEC™ PF
XRZFT
Opti™ LEAP®
Pebax
N/A
Pebax / Nylon
Pebax / Nylon
Crystalline
N/A
material
Co-Polymer
Bioslide® hydrophilic-
Coating
LFC hydrophilic
Hydrophilic
shaft
Hydrocoat
Supraglide
SiLX2
SiLX2
Hydrophilic
Hydro-X
Xtra hydrophobic-
hydrophilic
(Hydrophilic)
balloon
2.4 / 2.6 distal,
2.9 distal,
2.2 distal,
2.3distal,
2.5 / 2.7
2.4 distal,
Shaft
1.9 prox. (RX)
2.3distal,
1.9 prox. (RX)
2.6 distal,
2.36 distal,
2.0 prox. (RX) 2.2 distal,
2.1 prox.
distal,
N/A prox.
diameter (F)
2.1 prox. (RX)
1.7 prox.
1.9 prox.
3.3 prox. (OTW)
2.4 / 2.6 distal,
(RX)
2.2 prox. (RX)
Distal N/A,
(RX)
3.2 prox. (OTW)
3.0 prox. (OTW)
Marker
Single and Double
Single
1 or 2
Single
Single
Single
Single
Single
Single
*From manufacturer’s published literature unless otherwise specified
+ Test data on file at Medtronic Inc. Bench test results may not be indicative of clinical results
Not

57. Optimizing Balloons (Non-Compliant)
Numerous non-compliant balloons are available across global markets.
NC Euphora
NC Sprinter
Quantum Apex*
NC Trek
Hiryu*
NC Empira
(Medtronic)
(Medtronic)
(Boston)
(Abbott)
(Terumo)
(Cordis)
Tip Entry
0.015
0.016
0.016
0.017
N/A
0.018
Profile (in)
Catheter
Design RX RX
RX and OTW
RX and OTW RX RX
Length (mm)
6,8,12,15,20,27
6,9,12,15,21,27
6, 8, 12, 15, 20, 30
6, 8, 12, 15, 20, 25
6, 10, 15, 20
6,10,12,15,20,25,30
Diameter (mm)
2.00 – 5.00
1.50-5,00
2.25 – 5.00
Usable Shaft
142
138
143
N/A
N/A
139
Length (cm)
Balloon
Light
Fulcrum Plus
N/A
CrossFlex ®
N/A
DURALYN® Flex
Material
Coating
Selective DuraTrac
Selective DuraTrac
N/A
Hydrophilic coating
Hydrophilic
PTFE
2.00 – 3.75mm
2.00 – 3.75mm
Distal 2.5F
Distal 2.4F /2.6F
Proximal 1.9F
Proximal 1.9F
Proximal 1.9F
Shaft
RX: 2.4 distal,
2.7 distal,
distal,
Distal 2.7F
Diameter (F)
2.1 prox.
1.9 prox.
2.0 prox.
4.00 – 5.00mm
4.00 – 5.00mm
Distal 2.7F
Distal 3.0F
Proximal 1.9F
Proximal 1.9F
Marker
Double
Double
Double
Double
Double
Double
NP (atm) 12 10 12 12 10 10
RBP (atm) 20 18 18 18
20-22 20
*From manufacturer’s published literature unless otherwise specified
+ Test data on file at Medtronic Inc. Bench test results may not be indicative of clinical results
Not

58. Optimizing Balloons (Non-Compliant)
Numerous non-compliant balloons are available across global markets.
Maverick
NC Euphora
NC Sprinter
Dura Star RX*
Quantum*
Voyager NC*
BEO NC*
OPN NC*
(Medtronic)
(Medtronic)
(Cordis)
(Boston)
(Abbott)
(SIS)
(SIS)
Tip Entry
Profile (in)
0.015
0.016
0.017
0.017
0.018
0.016
0.016
Catheter Design RX RX RX
RX and OTW RX RX RX
Length (mm)
6,8,12,15,20,27
6,9,12,15,21,27
10, 15, 20, 25, 30
8, 12, 15, 20, 30
6, 8, 12, 15, 20, 25
10,12,15,17,20,22
10,15,20
Diameter (mm)
2.25 – 4.00
2.00 – 5.00
2.00 – 5.00
Usable Shaft
Length (cm)
142
138
145
150
143
N/A
N/A
DURALYN®
Quantum™
Balloon Material
Light
Fulcrum Plus
(Nylon Vestamid)
LEAP®
Pebax
N/A
N/A
Coating
Selective DuraTrac
Selective DuraTrac
Hydrophilic coating
BioslideTM
Hydrophilic
N/A
N/A
2.00 – 3.75mm
2.00 – 3.75mm
Distal 2.5F
Distal 2.4F /2.6F
Proximal 1.9F
Proximal 1.9F
Shaft
2.7 distal,
RX: 1.9
2.5 distal,
N/A
N/A
Diameter (F)
1.9 prox.
OTW: 3.2 prox.
2.3 prox.
4.00 – 5.00mm
4.00 – 5.00mm
Distal 2.7F
Distal 3.0F
Proximal 1.9F
Proximal 1.9F
Single (6mm)
Marker
Double
Double
Double
Double
Double
Double
Double (>6mm)
NP (atm) 12 10 14 12 12
N/A
N/A
RBP (atm) 20 18
20-22 16 18 24 35
*From manufacturer’s published literature unless otherwise specified
+ Test data on file at Medtronic Inc. Bench test results may not be indicative of clinical results
Not

59. Optimizing Balloons (Non-Compliant)
Numerous non-compliant balloons are available across global markets.
LaCrosse*
Nimbus
NC Euphora
NC Sprinter
Force NC*
Powered
SalvoTM*
Panterra Leo*
Sapphire NC*
(Medtronic)
(Medtronic)
(Blue Medical)
(Goodman)
(ClearStream)
(Biotronic)
(Orbus Neich)
Tip Entry
0.015
0.016
0.016
0.017
0.017
0.018
N/A
Profile (in)
Catheter Design RX RX RX RX RX
N/A RX
Length (mm)
6,8,12,15,20,27
6,9,12,15,21,27
N/A
8, 10, 12, 15, 18
9, 13,17, 21, 25, 33
8, 12, 15, 20, 30
8, 10, 12, 15, 20
Diameter (mm)
2.0 – 4.5
2.25 – 4.50
2.50 – 4.00
2.00 – 5.00
2.00 – 5.00
Usable Shaft
142
138
154
143
138
145
140
Length (cm)
Non compliant
Semi Crystalline
Balloon Material
Light
Fulcrum Plus
LCMTM
Pebax / Nylon
N/A
Polyamide
Polymer
Supraglide
Coating
Selective DuraTrac
Selective DuraTrac
Hydrophilic
(Hydrophilic)
SiLX2
Hydrophilic
N/A
2.00 – 3.75mm
2.00 – 3.75mm
Distal 2.5F
Distal 2.4F /2.6F
Proximal 1.9F
Proximal 1.9F
Shaft
2.4 distal,
2.5 / 2.7 distal,
distal,
distal,
2.7 distal,
Diameter (F)
1.9 prox.
2.2 prox. (RX)
1.7 prox.
2.0 prox.
1.9 prox.
4.00 – 5.00mm
4.00 – 5.00mm
Distal 2.7F
Distal 3.0F
Proximal 1.9F
Proximal 1.9F
Marker
Double
Double
N/A
Double
N/A
N/A
Double
14 ( )
NP (atm) 12 10 12 12 14 12
12 (>3.50)
2.0 – 4.0 / 20
2.0 – 4.0 / 20
2.25 – 4.0 / 20
RBP (atm) 20 18 20 18
>4.0 / 18
>4.0 / 18
>4.0 / 18
*From manufacturer’s published literature unless otherwise specified
+ Test data on file at Medtronic Inc. Bench test results may not be indicative of clinical results
Not

60. Balloons for Special Indications
Alternative balloon designs meet specialized procedural and lesion requirements.
Category
MOA
Indication
Manufacturer
Can be used when long
Allows blood to flow through
Perfusion
inflations are needed i.e.
Numerous
perfusion ports on shaft
perforation
Low pressure perfusion catheter which
Therapeutic
incorporates a thin, semi-compliant
Small vessels
Atrium (ClearWay)
Perfusion
microporous PTFE balloon material to
deliver small quantities of medication
Knobs incorporated into a NC
Calcified or ISR lesions
Grip
balloon to avoid balloon
Acrostak (GRIP)
slippage during inflation
Atherotomes affixed to a balloon, expand
Cutting
Score calcified or ISR plaque
BSX (Flextome)
radially as balloon is inflated
Focuses uniform radial forces along the
Scoring
Calcified, fibrotic, or ISR lesions
Biotronik (AngioSculpt)
edges of the nitinol element
ISR, bifurcations and small
Many, including: MDT,
Anti-restenotic drug is delivered to the
DEB
vessels, where adding metal is
B.Braun, Bayer-Medrad,
tissue during balloon inflation
not a good option
Biotronik
Not

61. PRE-DILATATION
Not

62. Pre-Dilatation Procedure
Pre-dilatation is the use of a balloon prior to the implantation of a stent gaining access
to the lesion or to determine the attributes of the lesion to aid in stent selection.
Lesion is crossed with
a balloon.
The balloon is inflated to
dilate and size the lesion. •
The lesion is opened enough
to allow the passage of a stent
delivery system.
Not

63. Pre-Dilatation Rationale
Pre-dilatation aids in determining lesion length, diameter and morphology.
Determine lesion length / diameter – What size stent should be used?
• Do not want to miss a part of the lesion with a stent that is too short
• Do not want to under- or over-expand a stent to reach the appropriate size.
Determine lesion morphology – is the lesion dilatable?
• Lesion may be too tight to cross with a stent
• May need to ‘crack’ a calcified lesion in order to achieve a better result with the stent
Pre-dilatation is recommended in the Drug Eluting Stent IFUs
Not

64. Pre-Dilatation – When It’s Appropriate
Pre-dilatation is appropriate in any complex lesion,
where passage and deployment of a stent may be challenging.
•Coronary lesions with significant calcification may be
Calcified Lesions
difficult to expand
•Pre-dilatation minimizes the risk of inadequate stent expansion
CTOs
•These complex coronary lesion treatments may be facilitated by
initial angioplasty with a small diameter balloon, followed by
Angulated Lesions
larger sized balloon catheters or stents
B2/C Lesions
•Pre-dilatation may limit stent length and reduce complications3
•Kissing balloon technique (KBT) is an important part of stent
optimization, used in bifurcation lesions1
Bifurcations
•EBC recommends the use of non-compliant balloons to prevent
over-dilatation during kissing inflations2
1. Sgueglia , et.al. JACC CI 2012
2. Hildick-Smith et al. EuroIntervention 2010;6:34-38
3. Kandzari, CCI 2010
Not

65. POST-DILATATION
Not

66. Post-Dilatation Procedure
Post-dilatation ensures full stent expansion and apposition to the vessel wall.
With the introduction of a DES, post-dilatation ensures the stent is fully
apposed allowing the drug to be in contact with the artery wall1
After a stent is deployed,
a non-compliant balloon is
delivered to the stent site.
The balloon is inflated,
applying high pressure to the
stent, pressing it firmly into •
the vessel wall. Inflation time
depends on balloon volume.
The balloon is deflated and
withdrawn, leaving a well
apposed stent in place.
1. Cowley TCT 200.8
Not

67. Pre-Dilatation – Potential Limitations
Pre-dilatation may be associated with increased cost, procedural and radiation exposure times.
Dissection
Increased
Increased
Increased intimal
procedural time,
procedure cost
damage
A tear created
fluoro time, and
and operational
within the tissue
Dilating the vessel
wall. Requires a
contrast use
inefficiencies
more often creates
stent and drug
more vessel trauma
Could have clinical
Uses more resources
therapy or CABG for
effects with
and lengthens
more severe cases
exposure to more
procedural time
radiation, potential
allergies to iodine
in contrast and
contrast load
to the kidneys
Thuraia Nageh et al. J Invasive Cardiol. 2003;15(3)
Intimal hyperplasia image – sciencedirect.com
Not

68. Post Dilatation Rationale
Full stent apposition is key to achieving positive, long-term outcomes.1,2
DES studies have shown that stent under
expansion is common in initial stent
“Inadequate stent expansion results in
deployment and a strong predictor of
abnormal shear stress that might be
stent thrombosis and target vessel
associated with stent thrombosis.”4
revascularization (TVR).1
“Of 256 patients with IVUS studies [...],
only 29% achieved optimum stent
deployment with the stent
delivery system.”3
Semi-compliant balloon material used in stent
delivery systems may not be adequate to achieve
full stent expansion in segments with heavy plaque
burden and increased resistance.3
Brodie et al, CCI 2003 1.
Brodie. J Interv Cardiol. 2006 2.
Fitzgerald & Leon. Netherlands Heart Joumal, Volume 14, Number 9, September 2006 3.
Brodie et al, CCI 2003 4.
Fuji et al, Journal of the American College of Cardiology 2005
Not

69. Post Dilatation – With Non-Compliant Balloon
Non-compliant balloons are more suitable for post-dilatation versus semi-compliant balloons.
Semi-compliant balloons, including stent delivery balloons:
• Continue to grow with added pressure, which can lead to over expanded stents.
• Conform to the lesion, allowing for an unevenly deployed stent
• May grow outside the stent length, damaging healthy tissue creating
‘edge effect’ restenosis
Non-compliant balloons:
• Offer the best opportunity for good stent/vessel apposition due to high pressure
& low compliance
• Recommended in the stent IFUs
Brodie. J Interven Cardiol. 2006
Not

70. Stent Malappostion – Contributing Factors
The objective of post-dilatation is to optimize stent apposition to the vessel wall.
You cannot determine if a stent is well apposed based on angiography alone.
Low
pressure stent
deployment
Bifurcation
Long lesions
lesions
requiring
treated with
multiple
stenting of
stents
side branch
Stent
Malappostion
Contributing
factors
Lesions
Lesions with
with severe
heavy
stenosis
calcification
Treatment
of diffuse
in-stent
restenosis
Romagnoli JACC CI 2008
Not

71. Stent Deployment Optimization
High pressure, non-compliant balloons are used to ensure a uniform distribution of
wall stress, maximal stent expansion and stent strut apposition.
Non-compliant (NC)
Stent Optimization Goals3
balloon Attributes
• Complete stent apposition to the vessel wall
• High pressure, non-compliant balloons
• Adequate stent expansion
should be used post stent deployment 1
• The non-compliant balloon used is shorter
• Full lesion coverage without edge dissection
and usually one-quarter size larger 2.
Risk of “dog bone”/edge effect with
SC balloon at high pressure
Protruding
Malapposed
Apposed to the intima
No contact to the intima
but not embedded
1. Romagnoli et al, J Am Coll Cardio Intv. 2008
2. Henry K Lui MD Cath Lab Digest
3. Yoon & Hur. Korean J Intern Med 2012
NC balloon at high pressure
Not

72. Post-Dilatation Risks
Post dilatation is not without risk.
Increased
Edge
Longitudinal
Increased
Distal
procedure cost
Dissection/
Stent
intimal damage
Embolization
and
Perforation
Deformation
Dilating the
A distal filling
operational
A tear created
Some stents have
vessel more often
defect with an
inefficiencies
within the tissue
been prone to
creates more
abrupt ‘cut-off’
wall. Requires
LSD when
vessel trauma
in one of
Use up
more resources
another stent and
re-crossed.
the peripheral
drug therapy or
coronary
during longer
branches of the
procedure time
CABG for more
severe cases
infarct related
artery, distal
to the
angioplasty site
Frobert et al. PLoS ONE 2013
Ormiston, CRT 2013
J. P. S. Henriques, et al. European Heart Journal, 2002
Intimal hyperplasia- sciencedirect.com
Not

73. Post-Dilatation – When It Is Appropriate
Post-dilatation is an appropriate treatment in most complex lesions.
To achieve full stent expansion 1
To improve stent apposition or
when it is visibly not apposed to
the wall
Long lesion in a tapered vessel
1. DiMario C, et al, 2008
Not

74. Elect: Fast-exchange Balloon Catheter
 Lesion entry profile
  0.017"
 Shaft diameter
  Proximal: 2.0F; Distal: 2.4F  
(Ø mm) , 2.6F (Ø mm),
2.7F
  (Ø 3.75–4.0 mm)
 Recommended guide catheter
5F (min. I.D ")
Nominal Pressure
  7 bar
Rated burst pressure (RBP)
  18 bar (Ø 1.25mm), 16 bar (Ø 1.5-
2.25 mm),
 14 bar (Ø mm)

75. Balloon Angioplasty Role with Stenting Pre-dilatation Post-dilatation
Prepare lesion and vessel for stent implantation
Determine lesion length / diameter
Determine lesion morphology
Post-dilatation
Ensure full stent expansion and apposition in the vessel
Optimize Minimum Lumen Diameter (MLD)
Presenter
Balloon usage in PTCA procedures has changed with the development and widespread adoption of stent technology.
Currently, there are three main uses for a balloon during PTCA procedures:
Plain Old Balloon Angioplasty, or POBA: A procedure where the balloon is used alone to dilate the vessel. Because this procedure has been associated with higher restenosis rates, the percentage of pure POBA procedures has decreased significantly in the last five to 10 years and is now estimated to be less than 10% of all PTCA procedures.
Pre-Dilatation: The use of the balloon before the implantation of a stent, to gain access to the lesion, to prepare the vessel for the stent, or to determine the attributes of the lesion to aid in stent selection.
Post-Dilatation: The use of a balloon inside an already deployed stent. Post-dilatation is used by physicians to ensure that the stent is fully expanded or apposed in the vessel, ensure MLD, and help avoid complications such as SAT (Source: Cheneau, et al. Circulation 2003;108;43-47), that have been associated with unapposed stents. With the introduction of drug-eluting stents, proper stent apposition also ensures that the drug is in contact with the artery wall.

76. Gain lesion access/ prepare vessel for stent
Pre-dilatation
Gain lesion access/ prepare vessel for stent
Determine lesion length/diameter
Determine lesion morphology
Trade-offs
“Dog-boning”
Potential growth outside lesion
Unwanted vessel expansion
Presenter
Compliant and semi-compliant balloons are used primarily for pre-dilatation of a vessel prior to stent implantation.
More compliant balloons are typically made of a softer and more flexible material. In these balloons, pressure migrates to the area of the balloon with the least resistance which can be outside the lesion area or metal stent. This can cause a “dog-boning” effect which could result in damage of healthy tissue outside the intended treatment area, as shown in the illustration.

77. SUMMARY
• The design goals and product attributes of balloon dilatation catheters
are determined by their clinical needs
• There are three primary balloon catheter attributes:
– Deliverability – How successfully will the balloon reach the lesion?
• Important components are pushability and trackability
– Crossability – how easily will the balloon cross the lesion?
• Important components are lesion entry, crossing and wrap/re-wrap profiles
– Dilatation – Will the balloon successfully open the target?
• Important components are balloon sizing, positioning, radial force and inflation
• There are 2 main types of balloon delivery platforms:
– Over-the-wire
– Rapid Exchange
• A balloon’s radial force is impacted by its compliance - the growth in
balloon diameter per atm of inflation pressure. The two types of compliant
balloons are:
– Semi-compliant – grow and conform to the areas of least resistance as pressure
is increased
– Non-compliant – grow and conform less as pressure is increased
Not