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

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 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=341888 http://www.nobel-winners.com/Medicine/werner_forssmann.htm www.ohsu.edu/dotter/images/ctdotter.jpg Not

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

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

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

Dilatation Not

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 (%) = Diameter @ High ATM — Diameter @ Low ATM Diameter @ Low ATM (x 100%)

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

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.

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

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 2006. 437-445 Not

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

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

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

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

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)

(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

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.

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.

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

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

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.

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 10 -20 atm for NC balloons Not

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

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

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

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

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

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.

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.

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

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

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

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

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

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

Average deflation time of PTCA balloon catheters

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

Deliverability Not

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

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

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

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

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

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

Crossability Not

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

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

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

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

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

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

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, 2.4 - 2.5 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

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

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

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

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) 2.0-5.0 2.0-5.0 2.00 – 5.00 1.50-5,00 2.25 – 5.00 2.0-4.0 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, 2.5-2.6 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

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) 2.0-5.0 2.0-5.0 2.25 – 4.00 2.00 – 5.00 2.00 – 5.00 1.50-4.50 1.50-4.50 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

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) 2.0-5.0 2.0-5.0 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, 2.7-2.8 distal, 2.6-2.7 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 (2.25 -3.50) 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

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

PRE-DILATATION Not

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

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

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

POST-DILATATION Not

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

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

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

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

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

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

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

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

Elect: Fast-exchange Balloon Catheter  Lesion entry profile   0.017"  Shaft diameter   Proximal: 2.0F; Distal: 2.4F   (Ø1.25-1.5mm) , 2.6F (Ø 2.0-3.5mm), 2.7F   (Ø 3.75–4.0 mm)  Recommended guide catheter   5F (min. I.D. 0.056") Nominal Pressure   7 bar Rated burst pressure (RBP)   18 bar (Ø 1.25mm), 16 bar (Ø 1.5- 2.25 mm),  14 bar (Ø 2.5-4.0mm)

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.

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.

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