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Excimer Laser

Technology

2010 Spectranetics

All Rights Reserved. Approved for External Distribution D009733-00 032010

Agenda
Laser Physics
Mechanism of Photoablation
Application of Photoablation with
Laser Catheters
Laser Safety

2010 Spectranetics

All Rights Reserved. Approved for External Distribution D009733-00 032010

What Is Light?

(mJ)

Amplitude

Light = photon = energy


Photon has a dual nature as both wave & particle
Wave behaviors
Travels in a measureable height and length
Particle behaviors
Has measurable mass
Length

(meters)

308 nanometers

2010 Spectranetics

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Laser Basics
Light can be
Reflected- bounces off
Scattered- random dispersal
Transmitted- passes through a
medium unchanged
Refracted- change in direction
Absorbed- deposited in a tissue

2010 Spectranetics

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Laser Basics
Lasers= Monochromatic
Single wavelength

Photons travel in phase together


Forms collimated light
Stays focused over distance
Parallel paths

2010 Spectranetics

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LASER
Light
Amplification
by
Stimulated
Emission
of
Radiation
2010 Spectranetics

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Laser Basics

Light

Stimulated emission

Amplification

How Atoms Work, Retrieved 2/15/20, from http://science.howstuffworks.com/atom2.htm


2010 Spectranetics

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Laser

Requirements
Laser Medium
Excitation
Optics- High Reflector Mirror (HR)
- Output Coupler Mirror (OC)
2010 Spectranetics

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Excimer Laser Excitation


Laser medium

High voltage added

Hydrogen
Chloride
Xe

Xenon
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CL

A Photon is Born
Dimer

Excimer = Excited Dimer


2010 Spectranetics

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Lasers and the Light Spectrum


Ultraviolet

vs.

Infrared

248 nm KrFl
351 nm XeFl

2010 Spectranetics

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UV Lasers
UV Lasers (10 to 400 nanometer) are
unique because they
Carry photon energies high enough to break
molecular bonds (covalent)
Avidly absorb in biological tissue
Have shallow absorption depth, <100 microns
Reduces energy required to cut
Reduces collateral tissue effects
Are typically pulsed Lasers
Pulse width of 5 to 200ns
SPNCs ~120ns

2010 Spectranetics

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Why 308nm Excimer Laser?


308nm allows coupling into fiber optics
and delivery to the end of the catheter
135ns pulse duration allows for fiber
optic delivery

2010 Spectranetics

All Rights Reserved. Approved for External Distribution D009733-00 032010

The Science of
Spectranetics Excimer
Laser Ablation

2010 Spectranetics

All Rights Reserved. Approved for External Distribution D009733-00 032010

Mechanisms of Action
for Ablation

Photoablation is the use of light to breakdown, vaporize


and remove matter
Spectranetics CVX-300 Excimer Laser facilitates
photoablation via a variety of Spectranetics catheters to
remove arterial plaques and binding scar tissue
surrounding cardiac pacemaker ICD leads
Three distinct mechanisms of action contribute to Excimer
Laser photoablation
1. Photochemical
2. Photothermal
3. Photomechanical

2010 Spectranetics

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Mechanisms of Action
X

Photochemical

Photothermal

Photomechanical

Breaking
molecular bonds

Producing
thermal energy

Creating
kinetic energy

2010 Spectranetics

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1: Photochemical Mechanism
Breaking molecular bonds

0 - 135 billionths of a second

UV light pulse hits tissue for 135 billionths of a second (135ns);


the duration of the laser pulse
50 microns penetration
Billions of molecular bonds fractured per pulse
After 135 billionths of a second, laser energy is not emitted
2010 Spectranetics

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2: Photothermal Mechanism
Producing thermal energy

100 millionths of a second

Absorption vibrates the molecular bonds of the plaque


Vibration of bonds heats intracellular water
Water vaporizes, molecules break apart, therefore rupturing cells
Expanding vapor bubble forms in 100 millionths of a second (100 s)
1000 times the duration of the actual laser energy emission

2010 Spectranetics

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3: Photomechanical Mechanism
Creating kinetic energy

400 millionths of a second

Expansion and collapse of vapor bubble breaks down tissue


and clears by-products away from tip
By-products of ablation are water, gas, and small particles
Entire process time per pulse is 400 millionths
of a second (400 s)
4000 times the duration of the actual laser energy
emission
2010 Spectranetics

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125 billionths
of a second

100 millionths
of a second

400 millionths
of a second

Timeline of a Single Laser Pulse

Bonds
dissolve

Thermal
energy

Kinetic
energy

Photoablation

Rest Period

Rest Period

25 Hz

1.3%

98.7%

80 Hz

4.0%

96.0%

2010 Spectranetics

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Photomechanical Effect
Fast expanding vapor bubble from a single Excimer Laser pulse

45 Fluence

60 Fluence

2.0 mm Vitesse OS catheter in absorbing Liquid


2010 Spectranetics

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Photomechanical Tissue Removal

Point 9 in Gel Model


2010 Spectranetics

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Application of Photoablation
with Spectranetics Laser
Catheters

2010 Spectranetics

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Many Morphologies, One Technology


Photoablation with the excimer laser
ablation system vaporizes
Coronary

Peripheral

Lesion Morphology

TE/TT/TB

Multiple morphology lesions which may


be comprised of atheroma, fibrosis,
calcium and thrombus

ELCA

Lipid-based plaque

ELCA

Occluded saphenous vein graft disease

ELCA

Fibrotic plaque

ELCA

Moderately calcified lesions

2010 Spectranetics

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Laser Atherectomy Ablation


Technique
SIZE: Laser catheter diameter should not
exceed 2/3 of the reference vessel
diameter
SALINE: Essential to remove contrast
from the photoablation location
SLOW: Advance SLOWLY at a rate of
<1mm per second for cleaner and larger
lumens
2010 Spectranetics

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SIZE of Laser Catheter


Catheter to vessel size ratio should not
exceed 2:3
Catheter Size

Approximate Vessel Diameter

0.9mm

> 1.4mm

1.4mm

> 2.1mm

1.7mm

> 2.6mm

2.0mm

> 3.0mm

2.3mm

> 3.5mm

2.5mm

> 3.8mm

In situations where a conservative approach is desired,


size laser catheter to approximately vessel size.
2010 Spectranetics

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Maximum Settings
Peripheral
Product Description and Size
Peripheral OTW/RX

Maximum
Settings

Maximum
Timings

0.9 X 80

80/80

Continuous Pulsed On

Peripheral Turbo Elite


1.4, 1.7, 2.0, 2.3mm

60/80

Continuous Pulsed On

Peripheral Turbo Elite 2.5mm

45/80

Continuous Pulsed On

Peripheral Turbo-Tandem

60/80

Continuous Pulsed On

2010 Spectranetics

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Maximum Settings
Coronary
Product Description and Size
Coronary RX

Maximum
Settings

Maximum
Timings

Coronary ELCA Vitesse


0.9mm

60/40

5 sec On (pulsed)
10 sec Off

Coronary ELCA Vitesse 0.9mm X80

80/80

10 sec On (pulsed)
5 sec Off

Coronary ELCA Vitesse 1.4,1.7,2.0


Coronary ELCA Vitesse Eccentric
1.7E,2.0E

60/40

5 sec On (pulsed)
10 sec Off

2010 Spectranetics

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Peripheral OTW Saline Infusion


Always perform 10-20cc bolus saline
infusion via the crossover sheath or
guide catheter after contrast injections

2010 Spectranetics

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Slow Advancement
Advance the catheter at <1mm per
second for optimal results.
6 cm lesion = 60 seconds =
minimum of 1 minute to cross

2010 Spectranetics

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Slow Advancement is KEY!


FAST

Simulated lesion

SLOW

Simulated lesion

Lumen diameter with


FAST ADVANCEMENT
(greater than 1 mm per
second).

Lumen diameter with


SLOW ADVANCEMENT
(less than 1 mm per
second.)

2.3 TURBO in 6mm tube

2.3 TURBO in 6mm tube

2010 Spectranetics

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Slow Advancement Is KEY!

SLOW
6mm lumen

6mm lumen diameter with


SLOW ADVANCEMENT
(less than 1 mm per second)

FAST
3mm lumen

3mm lumen diameter with


FAST ADVANCEMENT
(greater than 1 mm per second)

2.5 Turbo-Booster in 20mm lesion model, longitudinal view


2010 Spectranetics

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Fast Catheter Advancement


(What to avoid!)

2010 Spectranetics

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Key Point - Slow


Excimer Laser removes plaque slowly
For best results- catheter must be
advanced slowly
Slow advancement <1mm/s results in
Larger lumens
Cleaner lumens
Reduced occurrence of dissections

2010 Spectranetics

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Calcium Ablation with the


Excimer Laser

2010 Spectranetics

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Engineering Observations
With high density catheter and higher fluences, penetration
is slow in moderate calcium. Resulting hole size is very
close to catheter tip diameter.

Point 9 at 80/80 completely penetrates 1mm of calcium after 33


seconds of lasing. In comparison, the Point 9 will penetrate
same thickness of porcine aorta and bovine tendon in 1.2 and
1.7 seconds, respectively.*
* Data on file at Spectranetics
2010 Spectranetics

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Calcium Ablation Key Points


308nm excimer laser ablates calcified plaque*
The fluence threshold for moderately calcified lesions
is much higher than other lesion morphologies use
fluences of 60 mJ/mm2 and higher (if available)
For moderately calcified lesions it is recommended to
start with the highest Fluence / Rep Rate
combination
Penetration is very slow in moderately calcified
tissues, therefore patience is often required

* Data on file at Spectranetics


2010 Spectranetics

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Calcium Ablation Key Points


High fluence catheters like the Pt9 X80
(coronary) and the Turbo Elite OTW
(peripheral) lines are the best choices for
calcified plaque
Ablated lumen size in hard calcium is
approximately the same size as the tip
This can lead to shaft binding in longer lengths
of hard calcified lesions
Downsizing the catheter may be a good
strategy in this situation
2010 Spectranetics

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Laser Safety
Operators trained per IFU
Secure environment
Laser signs posted on all entrances
Laser signs must state the laser classification,
wavelength and that eye protection is required
The CVX-300 is a Class IV Laser System
The CVX-300 is a Class 3 Medical Device (FDA)
The wavelength of the laser light is 308 nanometers
(nm) which is invisible to the human eye

2010 Spectranetics

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Laser Safety
Eye protection
Everyone in the room must wear eye
protection, including the patient
Must be labeled with optical density (O.D.)
at laser wavelength
O.D.= 9 @ 308 nanometers (CVX-300 safety
glasses)

2010 Spectranetics

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Laser Safety
Common safety sense:
Never directly view laser beam, even with
proper eye protection
Handle the catheter with care - never point
the catheter at anyone

2010 Spectranetics

All Rights Reserved. Approved for External Distribution D009733-00 032010

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