Professional Documents
Culture Documents
FD159D
FD159D
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
FD159D
Characteristics
Onyx delivers in a cohesive manner
Analogy of lava demonstrates characteristics of
behavior).
Onyx Precipitate
External Surface
Onyx Precipitate
Internal Surface
FD159D
Device Components
FD159D
VS.
Scale = centistokes
30
25
20
600
15
500
10
400
300
Water
Human
Blood
25%
nBCA
6%
6.5
8%
200
100
0
6%
6.50%
8%
20%
FD159D
DMSO
(Dimethyl Sulfoxide Solvent)
FD159D
FD159D
FD159D
FD159D
AJNR,
March 1999
FD159D
DMSO Overview
Procedure Guidelines
Please refer to the Instructions for Use for
full prescribing details
FD159D
Onyx Animation
FD159D
Superselective
Contrast Injection
Confirm micro
catheter placement
Contrast agent per
institutional
procedure
FD159D
Flush Microcatheter
FD159D
FD159D
FD159D
FD159D
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
Onyx Preparation
1.
Shake Vials
20 minutes
5. Connect Onyx
Syringe vertically
2. Flush Catheter
6. Displace DMSO
0.25ml / 90 secs
4. Overwash
catheter hub
7. Fluoro just
prior to filling
deadspace
FD159D
Onyx AVM
Technique
FD159D
FD159D
FD159D
Forward Penetration
Pause
Continue
Constant Slow Rate
:30 Seconds
Momentum Break
2:00 Minutes
Solidify Plug
Re-Inject
Repeat Process
FD159D
Potential Risks
Possible reflux
Catheter Removal
FD159D
Microcatheter Retrieval
Contribution / Flow
Onyx Technique
Waiting Time /
Pressures
Microcatheter Position
Injection Speed
Delivery Rate
Imaging/Working Projection
Reference Images
FD159D
Feeder Selection
Feeder Selection
FD159D
Microcatheter Position
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
FD159D
Injection Rate
The Slower The Better
Better Control and Better
penetration overall
More penetration before
reflux and more control
when reflux occurs
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
FD159D
Retrieval Techniques:
Two Paths
Slow Traction
Technique
FD159D
FD159D
FD159D
Is the vasculature
straightening ?
FD159D
FD159D
0cm
20cm
NOTE: It is not necessary to move the entire arm (such as a glue technique). This
technique can risk catheter separation.
FD159D
FD159D
Rebar
Echelon 10 and 14
Mirage
X-pedion, SilverSpeed
Guidewires
FD159D
Onyx Catheters
Onyx Delivery Catheter
Over The Wire
Benefits
Reinforced
High Tensile Strength
Burst Profile
Uses
Coils
Liquid Embolics
Particles
UltraFlow
Marathon
Apollo, 2009
FD159D
400
350
18x tolerance
300
250
200
150
100
50
0
0.1 ml / min
Onyx 18
Injection
UltraFlow
Marathon
FD159D
Wait Time
30 secs 1min
1.5min 2min
3min
5min
FD159D
Summary:
Burst Performance
If Onyx is not exiting tip, do not inject more than 0.05 ml into a potentially
occluded catheter.
FD159D
70
Retrieval Force
60
Grams
50
40
30
20
10
0
UltraFlow
Marathon
FD159D
600
400
Grams
500
300
71%
200
130%
130%
100
Magic 1.2
Magic 1.5
Spinnaker
UltraFlow
Marathon 1.3
FD159D
Recommended
Traction Limit < 20cm
400
Stretch Point
to Breakage
300
200
100
0
1cm
3cm
5cm
10cm
15cm
20cm
43cm
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.
FD159D
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.
FD159D