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Onyx Liquid Embolic System

Physician Orientation Review


International

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Materials and Indications


This presentation is intended for the purpose of
didactic review with physicians regarding the use
of the Onyx LD Embolic System
Model #s 105-7000-060, 065, 080 (Onyx 18, 20, 34)

Indications for Use: Embolization of lesions in


the peripheral and neurovasculature, including
arteriovenous malformations and hypervascular
tumors.

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Onyx Development
Ongoing research since 1993
Human clinical studies commenced 1997
Name change 1999: Embolyx to Onyx (LES)
CE Mark received for AVM indication, July
1999
Regularly used since then in Europe

Estimated worldwide procedures: 15,000+


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Onyx Liquid Embolic System

Ethylene-vinyl alcohol copolymer


EVOH

Dimethyl Sulfoxide Solvent


DMSO

Micronized tantalum powder


Ta

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Onyx Embolization Process

Onyx is a pre-mixed, radiopaque, injectable embolic


fluid.

Polymer precipitation occurs upon contact with


aqueous solution.

Contact with blood = Precipitation

Solvent diffuses away

Forms a spongy polymeric cast

Forms a skin - solidifies from the outside in

Liquid center continues to flow


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Characteristics
Onyx delivers in a cohesive manner
Analogy of lava demonstrates characteristics of
behavior).

Onyx Precipitate
External Surface

Onyx Precipitate
Internal Surface
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Device Components

1.5 ml vial of Onyx


Onyx 18, 105-7000-060
Onyx 20, 105-7000-065
Onyx 34, 105-7000-080
1.5 ml vial of DMSO
MTI 1 ml luer-lock delivery syringes

2 white for Onyx,

1 yellow for DMSO

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Onyx Relative Viscosity


Onyx LD - AVM Formulations
40
35

VS.

Scale = centistokes

30

Onyx HD - Aneurysm Therapy

25
20

600

15

500

10

400

300

Water

Human
Blood

25%
nBCA

6%

6.5

Viscosity doubles between


Onyx 18 (6%) to Onyx 34 (8%)

8%

200
100
0
6%

6.50%

8%

20%

Onyx AVM v. HD for Aneurysms

Entirely Different Viscosity

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DMSO
(Dimethyl Sulfoxide Solvent)

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DMSO Study Review

In 90 - 91 Taki and Terada successfully described embolization


with EVAL dissolved in DMSO

Safety concerns emerged

Chaloupka and Viuela conducted early UCLA study - showed


severe vasospasm and angionecrosis

Subsequent studies show safety of the Onyx delivery protocol


Dr. Chaloupka (1999)
UCLA (1998)

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Chaloupka et, al., UCLA,


AJNR, June 1994

1st study: DMSO intra-arterial injections in volumes


0.5 mL and 0.8 mL
Injected over a timeframe of 15 seconds or less

Rete mirabile of 29 swine


When injected over relatively rapid timeframes
DMSO was reported to cause moderate to severe
vasospasm
Sub arachnoid hemorrhage (SAH), stroke or death

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Murayama, (et al) UCLA,


Neurosurgery, November 1998

Embolyx E (now Onyx) and its solvent DMSO


44 rete mirabile in 22 swine

Study showed two important factors influencing


vascular toxicity:
Contact time with arterial wall
Volume of DMSO

Fast delivery (0.5 mL in 5-15 seconds)


Caused severe vasospasm and histological endothelial
necrosis

Slow delivery (0.5 mL in 30-120 seconds)


Showed no vasospasm, minimal inflammation and no
complications
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Chaloupka, (et al) AJNR,


March 1999

At MTIs request, Dr. Chaloupka agreed to conduct a


2nd study reexamination DMSO angiotoxicity
Purpose was to evaluate the effects of intra-arterial
DMSO injections at slower rates of 30, 60 and 90
seconds
Rete of 26 swine
No acute hemodynamic alterations
No infarction or SAH

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Chaloupka, (et al)

AJNR,

March 1999

No significant changes in arterial blood pressure


No alterations in heart rate or ECG
Conclusion:
Found that lower dose rates of superselectively infused DMSO
are associated with a more acceptable safety and histotoxicity
profile than previously reported
Chaloupka confirmed Murayamas results

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DMSO Overview

Enters the bloodstream and is absorbed into tissues


Metabolized to dimethyl sulfone (DMSO2) and
dimethyl sulfide (DMS)
80% of these metabolites are eliminated via the kidneys in
urine within a week
Also eliminated via the skin or lungs which causes a garlic
odor to the breath

Complete elimination: 13-18 days


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Procedure Guidelines
Please refer to the Instructions for Use for
full prescribing details

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Onyx Animation

Onyx AVM Animation available

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Shake Onyx Vials

Place vials on mixer


Set mixer to maximum
setting
Shake for a minimum of 20
minutes
Maintain shaking of vials
until ready to use
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Superselective
Contrast Injection

Confirm micro
catheter placement
Contrast agent per
institutional
procedure

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Flush Microcatheter

Flush contrast from


micro catheter
IFU state 10ml of
saline

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Prime Catheter with DMSO

Aspirate 0.8 mL DMSO into the


yellow MTI DMSO 1 mL syringe

Inject DMSO to sufficiently fill


dead space of delivery catheter
Marathon = 0.23mL
UltraFlow HPC = 0.26mL

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Prepare Onyx Delivery Syringe

Remove prepared vial


from shaker
Aspirate 1 mL Onyx into
the white MTI Onyx 1 mL
syringe
Using an 18 or 20 gauge
needle

Clear any air bubbles


within the syringe and hub
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Overfill Hub with DMSO

When ready to deliver


Onyx, remove DMSO
syringe
Hold the micro catheter
hub in a vertical position
Overfill hub of the
catheter with the balance
of DMSO

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Onyx Delivery Syringe

Connect Onyx syringe to the


hub.

For optimal fluoroscopic


visualization, quickly point
vertically to create an interface
between DMSO and Onyx.

While holding the syringe


vertically, begin injection Onyx
to displace DMSO.

Inject Onyx at the


recommended slow, steady
rate of:
0.25ml over 90 seconds,
(approx. 0.1 mL/min)
IFU states: Do not exceed a
0.3 mL/min
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Continue Injecting Onyx

Continue holding the syringe


vertically until Onyx passes
through the hub

Once Onyx passes through the


hub, the syringe may be held in a
comfortable (horizontal) position

Begin fluoroscopic imaging just


prior to delivering catheter dead
space:
Marathon = 0.23mL
UltraFlow HPC = 0.26mL

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Detachment of Catheter
After completion of Onyx
injection, slightly aspirate
syringe: Only 0.1ml is needed
Gently, slowly and
incrementally pull the
catheter a few centimeters at
a time.
Tension will increase in
catheter
Hold when sufficient tension is
reached
Gradually increase

Catheter will release


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Onyx Preparation

1.

Shake Vials
20 minutes

5. Connect Onyx
Syringe vertically

2. Flush Catheter

3. Load dead space


with DMSO

6. Displace DMSO
0.25ml / 90 secs

4. Overwash
catheter hub

7. Fluoro just
prior to filling
deadspace

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Onyx AVM
Technique

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Plug and Push Technique

Create a plug around catheter tip


Allow use of Flow Arrest to promote distal movement
Use a waiting technique to create change in pressure
Can help improve penetration
Must balance with cautions and risks

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Hints for Plug and Push


Technique

Re- road map after each injection cycle (wait time)


This will help monitor deposition and movement of new material

May be necessary to repeat cycle multiple times during an injection


When material first begins to reflux
wait :30 seconds to break the motion
upon re-injection again the material should move distally
As a full circumferential plug forms
wait up to 2:00min to solidify flow arrest

When beginning injection SLOW gentle injection will help control


new deposition

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Technique Decision Tree


Begin Slow Onyx
Injection
Reflux (laminar/plug) ?

Forward Penetration

Pause

Continue
Constant Slow Rate

:30 Seconds
Momentum Break

2:00 Minutes
Solidify Plug

Re-Inject
Repeat Process
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Potential Risks

Using Plug and Push can create conditions that should


be monitored closely.
Waiting time
Catheter occlusion/pressure build up

Possible reflux
Catheter Removal

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Fundamentals of AVM Embolization


Imaging/Working
Projection
Pedicle Selection Size

Microcatheter Retrieval

Contribution / Flow

Onyx Technique
Waiting Time /
Pressures

Microcatheter Position

Injection Speed
Delivery Rate

Are Critical to Onyx Performance


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Imaging/Working Projection

Always work with Reference Image and Working Projection

A reference image becomes very useful during long Onyx


injections
Catheter distal shaft
Nidal Angioarchitecture
Primary venous drainage

Optimize working projection:

Separation of catheter tip, minimal foreshortening of catheter


Allows to recognize, measure and manage reflux
Instructions for Use recommends a maximum of 1cm reflux
Modifications based on anatomy
Distal turn or bend in catheter tip
Select a point on catheter (a turn or bend) to use as a reference and
reflux limit
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Reference Images

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Feeder Selection

Larger contributing feeders seem to


promote penetration:
Generally easier to reach nidal position
Generally provide a greater pressure
gradient
Therefore can capitalize on Onyx
characteristics for better penetration.
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Feeder Selection

Small pedicles can have limited penetration


Especially if proximal because of change in pressure as feeder
fills can cause limited nidal penetration.
Must inject very slowly, control reflux, and expect possibly limited
nidal delivery from small feeders.
Risk of delayed catheter retrieval can occur because of
potential spasm / reflux build up quickly.

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Microcatheter Position

Intra-nidal (or wedged) position seems optimal


Or as close as possible to nidus
Especially because Onyx performs best when pushed into the
lesion

Proximal positions:
May result in minimal nidal deposition and a feeder injection
As Onyx is delivered into feeder, the pressure gradient changes.
As feeder closes, the path of least resistance becomes retrograde
reflux occurs.
Plug and Push may not achieve same results as nidal position

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Injection Rate
The Slower The Better
Better Control and Better
penetration overall
More penetration before
reflux and more control
when reflux occurs

Rate must be constant


and slow

Using the DMSO


Displacement rate as a
reference
0.25ml over 90 seconds
= 0.16ml / minute
Continue this rate (or
slower)
Case examples: 0.10 0.15 ml / minute

Any change in injection rate


will create reflux
If rate is too fast, reflux will
occur quickly
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Catheter Retrieval
Consider all the
factors that can
affect difficult
catheter removal:

Tortuosity

Length of Reflux

Size of Feeder

Difficult Catheter
Retrieval

Distal 2cm
(loop, hook)

Time of Injection

Potential
for Spasm

Evaluating these parameters prior to injection can determine how much reflux will be accepted
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Retrieval Techniques:
Two Paths

Two Techniques Provide


Versatile, Effective Use

Slow Traction
Technique

Quick Wrist Snap


Technique

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Slow Traction Technique

Slowly, and incrementally (cm by cm), withdraw the catheter


Tension will slowly increase creating retrieval force directly to
the catheter tip
Sustain moderate tension (hold for a moment)
Catheter tip will release from Onyx cast
Completely withdrawal catheter

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Quick Wrist Snap Technique

Remove all slack from catheter. Withdraw catheter 3 5 cm.

This will create a slight tension throughout the catheter

Quickly move wrist from left to right (about 10 20cm)


No need to move the entire arm
This is NOT like a glue technique

This provides a spark of energy through the catheter


Without stretching the catheter too much and risking breakage

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Catheter Retrieval Management


Step #1: Apply gentle, incremental traction to catheter
(cm by cm)

Is the vasculature
straightening ?

Step #2: Assess risk of


spasm or vessel
damage

Is the Onyx cast


retracting?

Is the catheter tip


beginning to release
from Onyx cast?``

Step #2a: Sustain Traction and


Monitor Tip Release

Step #3: Release Traction and Repeat Decision Tree


Applying Intermittent Traction As Necessary

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Quick Wrist Snap - Steps

Remove all slack from the


catheter
By pulling a few cm.

Create slight tension

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Quick Wrist Snap - Steps


Quickly move wrist 10 15cm
to the right
Making a wrist snap motion

0cm

20cm

Quick but Short


Wrist Motion

NOTE: It is not necessary to move the entire arm (such as a glue technique). This
technique can risk catheter separation.
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Onyx Delivery Microcatheters

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Onyx Delivery Systems

Rebar

Marathon & Ultraflow

Echelon 10 and 14

Mirage
X-pedion, SilverSpeed
Guidewires

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Onyx Catheters
Onyx Delivery Catheter
Over The Wire
Benefits
Reinforced
High Tensile Strength
Burst Profile
Uses
Coils
Liquid Embolics
Particles

Soft Supple Tip


Superior Navigation
High Tensile Strength
Burst Pressure

UltraFlow

Flow Directed Catheter


Benefits
Soft Supple Tip
No Guidewire
Superior Navigation
Uses
AVM embo (nBCA)

Marathon
Apollo, 2009
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Embolic Injection Pressure v. Burst


psi

400
350

18x tolerance

300
250
200
150
100
50
0

0.1 ml / min

Onyx 18
Injection

UltraFlow

Marathon

Onyx injection requires very low pressure of approximately 20psi injected at a


rate of (0.1 ml / min)

Marathon provides a robust tolerance between Onyx injection pressure and


Onyx burst pressure and is more than 2x in UltraFlow

Source: TR 03-106, UltraFlow TR01-116


Test Method: TM0090, Onyx Plug & Push: 1 hour Onyx injections, repeated pressurization to intentional failure.
Engineering Note: Test results show that when catheter is intentionally ruptured, the UltraFlow fails between the fuse joint and distal tip, while Marathon fails in the distal
7cm.

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Pressure to Re-inject v. Wait Time


PSI
160
140
120
100
80
60
40
20
0

Wait Time

30 secs 1min

1.5min 2min

3min

5min

Recommendation: Limit Wait time less than 2 min.

Onyx mass can precipitate in 3 - 5 minutes.


The increased injection pressure (after a long wait) can approach this limit.

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Summary:
Burst Performance

Recognize occluded catheter if Onyx is not exiting catheter tip


Occlusion may occur after extended wait period during Onyx injection

Do not interrupt Onyx injection more than 2 minutes

If Onyx is not exiting tip, do not inject more than 0.05 ml into a potentially
occluded catheter.

Static Pressure to burst the UltraFlow or Marathon should be recognizable


to identify resistance.
If resistance is felt, stop Onyx injection.

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Detachment Force from Onyx Cast

Marathon design requires 25% less force to retrieve from a


cast of Onyx (see test method) than UltraFlow
Source:, Marathon TR 03-106, UltraFlow TR01-116
Test Method: TM 0090: Flow model, 3cm Onyx reflux, 1 hour dwell time, at body temperature, slow pull technique

70

Retrieval Force

60

Grams

50
40
30
20
10
0

UltraFlow

Marathon

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Distal Tensile Strength

600

400

Grams

500

Distal Tensile Strength

300

71%
200

130%

130%

100

Magic 1.2

Magic 1.5

Spinnaker

UltraFlow

Marathon 1.3

Marathon braiding provides significant tensile strength for excellent


catheter retrieval

Source: UltraFlow TR01-116, Marathon TR 03-106, Other Catheters: TR02-088


Test Method: TM0080 test a 1 distal segment gauge length, stretch to break at 20 / min

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FD Catheter Stretch Profile


600
500

Recommended
Traction Limit < 20cm

400

Stretch Point
to Breakage

300
200
100
0

1cm

3cm

5cm

10cm

15cm

20cm

43cm

Distance of catheter traction (cm)

Recommended Traction Limit should be < 20cm


Note: If catheter is trapped at distal tip - recommendation offers safety
margin to minimize risk of catheter separation.
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Access Summary

Tip shaping:
It is not necessary to overshape

Guidewire technique:
Some clinicians recommend keeping the guidewire placed just past the
distal tip marker during navigation. This helps maintain a patent lumen
and minimize risk of catheter prolapse

Angiographic technique
Some physicians suggest using a gentle, low volume puff of contrast to
confirm catheter patency.

Less Magnification / Larger Field of View


Prior to embolic delivery, it is suggested to deliver a small volume contrast
injection
While viewing the entire distal catheter segment to verify catheter integrity.

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Onyx Liquid Embolic System

Physician Orientation Review


International

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. A complete statement of indications, contraindications, warnings and
instructions can be found in the product labeling supplied with each device. WARNINGS: Serious, including fatal, consequences could result with the use of the Onyx LES
without adequate training. Contact your ev3 Sales Representative for information on training courses. Onyx is a registered trademark of ev3.

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