treatment of arteriovenous malformations Superior technologies for the

Superior technologies for the
treatment of
arteriovenous malformations
Contents
ev3 provides a full range of products for
interventional neuroradiology therapies.
1. Liquid Embolic System
5
- Onyx™
2. Flow Directed Microcatheters
Here we highlight our outstanding products for the treatment of
arteriovenous malformations. We offer a full range of products for
the Interventional Neuroradiologist including coils, liquid embolics,
microcatheters, guidewires and balloons, which have been
developed in close collaboration with leading clinicians and draw
on the latest advances in material science technologies.
3. Guidewires
ev3 is committed to developing innovative solutions, harnessing the
latest technologies, with the ultimate aim of enabling physicians to
better treat their patients.
4. Technical Facts
7
- Marathon™
- UltraFlow™
9
- Mirage™
- SilverSpeed™
- AqWire™
- X-Pedion™
- X-Celerator™
- Onyx™
10
Contents
ev3 provides a full range of products for
interventional neuroradiology therapies.
1. Liquid Embolic System
5
- Onyx™
2. Flow Directed Microcatheters
Here we highlight our outstanding products for the treatment of
arteriovenous malformations. We offer a full range of products for
the Interventional Neuroradiologist including coils, liquid embolics,
microcatheters, guidewires and balloons, which have been
developed in close collaboration with leading clinicians and draw
on the latest advances in material science technologies.
3. Guidewires
ev3 is committed to developing innovative solutions, harnessing the
latest technologies, with the ultimate aim of enabling physicians to
better treat their patients.
4. Technical Facts
7
- Marathon™
- UltraFlow™
9
- Mirage™
- SilverSpeed™
- AqWire™
- X-Pedion™
- X-Celerator™
- Onyx™
10
Perfectly controlled flow
Onyx, an embolic agent designed for
treating intracranial arteriovenous
malformations (AVMs), gives physicians
outstanding control to achieve almost
complete occlusion of an AVM.
Unique to ev3, Onyx is a non-adhesive liquid polymer
made of ethylene-vinyl-alcohol (EVOH) copolymer in a
dimethylsulfoxide (DMS0) solution. In contact with
blood, Onyx forms a soft skin that solidifies from the
outside inwards.
Since Onyx is non-adhesive and has unique solidification
characteristics, a large amount of embolic agent can be
delivered by a long single injection, which penetrates the
nidus microstructure of an AVM.
Onyx does not flow uncontrolled, but is ‘pushed’ forward
by the physician who can stop and if necessary re-start
the flow. This gives excellent control throughout the
procedure of Onyx embolisation.
Onyx is the only liquid embolic agent that allows a control
angiography to be conducted during the procedure in
order to assess the rate of occlusion. Fully informed at
every stage, the physician can judge if continuing of
injection is required.
In short, Onyx gives the physician the advantage of
control and timing over this complex procedure.
Onyx™ - At a glance
• excellent visibility
• controlled embolisation
• controlled injection and delivery method
• flexibility to stop and re-start the injection
• control angiography during embolic injection
• controlled catheter retrieval
• available in three viscosities: Onyx 18, Onyx 20
and Onyx 34
4
5
Perfectly controlled flow
Onyx, an embolic agent designed for
treating intracranial arteriovenous
malformations (AVMs), gives physicians
outstanding control to achieve almost
complete occlusion of an AVM.
Unique to ev3, Onyx is a non-adhesive liquid polymer
made of ethylene-vinyl-alcohol (EVOH) copolymer in a
dimethylsulfoxide (DMS0) solution. In contact with
blood, Onyx forms a soft skin that solidifies from the
outside inwards.
Since Onyx is non-adhesive and has unique solidification
characteristics, a large amount of embolic agent can be
delivered by a long single injection, which penetrates the
nidus microstructure of an AVM.
Onyx does not flow uncontrolled, but is ‘pushed’ forward
by the physician who can stop and if necessary re-start
the flow. This gives excellent control throughout the
procedure of Onyx embolisation.
Onyx is the only liquid embolic agent that allows a control
angiography to be conducted during the procedure in
order to assess the rate of occlusion. Fully informed at
every stage, the physician can judge if continuing of
injection is required.
In short, Onyx gives the physician the advantage of
control and timing over this complex procedure.
Onyx™ - At a glance
• excellent visibility
• controlled embolisation
• controlled injection and delivery method
• flexibility to stop and re-start the injection
• control angiography during embolic injection
• controlled catheter retrieval
• available in three viscosities: Onyx 18, Onyx 20
and Onyx 34
4
5
Precision access to distal anatomy
Marathon™, the leading flow-directed
microcatheter from ev3, also has
outstanding flexibility to reach very distal or
difficult anatomy, especially when used in
conjunction with a Mirage or SilverSpeed 10
guidewire.
Its proximal shaft is reinforced with a stainless steel
coil structure, for high proximal pushability, and is
combined with a very soft flow-directable tip.
Marathon has the lowest “true distal tip” and the lowest
crossing profile of any flow-directed microcatheter. The
outer diameter of the distal tip measures 1.3F and 1.4F
at the marker band, giving smooth navigation and access
to the lesion. This low profile tip also facilitates easy
retrieval from the embolic mass.
Many of Marathon’s outstanding characteristics result
from its innovative distal Nitinol braiding. Outstanding
softness and flexibility are combined with higher kink
resistance of Marathon due to the nitinol braid. Its high
embolic and angiographic burst resistance substantially
improves safety, while its high tensile strength allows
Marathon to be retrieved easily and smoothly.
When a more flow-directed microcatheter is required
UltraFlow, which has a larger 1.5F profile at the distal tip,
is a very good choice. Like Marathon, it also works
extremely well with the Mirage and SilverSpeed 10
guidewires.
Rebar over-the-wire microcatheters, as well as being
Onyx compatible, are also suitable for delivering coils.
Flow Directed Microcatheters - At a glance
Marathon™
• use as flow-directable or over the wire
• reinforced proximal shaft for high pushability
• 1.3F profile at the distal tip
• flexibility gives superb navigation
• excellent kink resistance
• high embolic and angiographic burst strength
• very high tensile strength for easy retrieval
• compatible with Onyx
• Nitinol braid
UltraFlow™
• use as flow-directable or over the wire
• 1.5F profile at the distal tip
• compatible with Onyx
6
7
Precision access to distal anatomy
Marathon™, the leading flow-directed
microcatheter from ev3, also has
outstanding flexibility to reach very distal or
difficult anatomy, especially when used in
conjunction with a Mirage or SilverSpeed 10
guidewire.
Its proximal shaft is reinforced with a stainless steel
coil structure, for high proximal pushability, and is
combined with a very soft flow-directable tip.
Marathon has the lowest “true distal tip” and the lowest
crossing profile of any flow-directed microcatheter. The
outer diameter of the distal tip measures 1.3F and 1.4F
at the marker band, giving smooth navigation and access
to the lesion. This low profile tip also facilitates easy
retrieval from the embolic mass.
Many of Marathon’s outstanding characteristics result
from its innovative distal Nitinol braiding. Outstanding
softness and flexibility are combined with higher kink
resistance of Marathon due to the nitinol braid. Its high
embolic and angiographic burst resistance substantially
improves safety, while its high tensile strength allows
Marathon to be retrieved easily and smoothly.
When a more flow-directed microcatheter is required
UltraFlow, which has a larger 1.5F profile at the distal tip,
is a very good choice. Like Marathon, it also works
extremely well with the Mirage and SilverSpeed 10
guidewires.
Rebar over-the-wire microcatheters, as well as being
Onyx compatible, are also suitable for delivering coils.
Flow Directed Microcatheters - At a glance
Marathon™
• use as flow-directable or over the wire
• reinforced proximal shaft for high pushability
• 1.3F profile at the distal tip
• flexibility gives superb navigation
• excellent kink resistance
• high embolic and angiographic burst strength
• very high tensile strength for easy retrieval
• compatible with Onyx
• Nitinol braid
UltraFlow™
• use as flow-directable or over the wire
• 1.5F profile at the distal tip
• compatible with Onyx
6
7
Superselective access
The Mirage or SilverSpeed 10 guidewire,
combined with the Marathon or UltraFlow
microcatheter, provides the ideal team for
achieving superselective access to an AVM.
Mirage’s unique 0.008” size provides appropriate support
for flow-directed catheter navigation and unsurpassed
distal access. With precise torque control and excellent
tip shape retention it can reach the most distal anatomy.
A durable hydrophilic coating allows Mirage to glide
through tortuous vasculature. This is the ideal guidewire
for less traumatic navigation.
The hydrophilic coating of Mirage also makes insertion
into a catheter exceptionally easy while a flexible tip
maintains its shape for precise access.
For more support, the SilverSpeed guidewire can be used
in the initial stages of catheter navigation.
When a large 0.018” or 0.035” guidewire is required,
the AqWire™ combines the exceptional lubricity of
a hydrophilic coating with the durability and kink
resistance of a solid Nitinol core. The result is liquidsmooth control in the most tortuous anatomy.
Guidewires - At a glance
Mirage™
• available in 0.008”
• soft coil tip for superselective access
• excellent tip shape retention
• durable hydrophilic coating
• precise torque control
SilverSpeed™
• available in 0.010”, 0.014”, 0.016” and 0.018”
• shapeable guidewire for direct access
• hydrophilic coating for easy insertion
• flexible tip for precise access
AqWire™
• large 0.018” or 0.035” guidewire
• exceptional lubricity
• durable and kink resistant
X-Pedion™
• available in 0.010” and 0.014”
• strong support for balloons and microcatheters
• exceptional pushability and force transmission
X-Celerator™
• available in 0.010” and 0.014”
• for swift and efficient exchanges
• hydrophilic and proximal PTFE coating
8
9
Superselective access
The Mirage or SilverSpeed 10 guidewire,
combined with the Marathon or UltraFlow
microcatheter, provides the ideal team for
achieving superselective access to an AVM.
Mirage’s unique 0.008” size provides appropriate support
for flow-directed catheter navigation and unsurpassed
distal access. With precise torque control and excellent
tip shape retention it can reach the most distal anatomy.
A durable hydrophilic coating allows Mirage to glide
through tortuous vasculature. This is the ideal guidewire
for less traumatic navigation.
The hydrophilic coating of Mirage also makes insertion
into a catheter exceptionally easy while a flexible tip
maintains its shape for precise access.
For more support, the SilverSpeed guidewire can be used
in the initial stages of catheter navigation.
When a large 0.018” or 0.035” guidewire is required,
the AqWire™ combines the exceptional lubricity of
a hydrophilic coating with the durability and kink
resistance of a solid Nitinol core. The result is liquidsmooth control in the most tortuous anatomy.
Guidewires - At a glance
Mirage™
• available in 0.008”
• soft coil tip for superselective access
• excellent tip shape retention
• durable hydrophilic coating
• precise torque control
SilverSpeed™
• available in 0.010”, 0.014”, 0.016” and 0.018”
• shapeable guidewire for direct access
• hydrophilic coating for easy insertion
• flexible tip for precise access
AqWire™
• large 0.018” or 0.035” guidewire
• exceptional lubricity
• durable and kink resistant
X-Pedion™
• available in 0.010” and 0.014”
• strong support for balloons and microcatheters
• exceptional pushability and force transmission
X-Celerator™
• available in 0.010” and 0.014”
• for swift and efficient exchanges
• hydrophilic and proximal PTFE coating
8
9
Onyx: technical facts
Onyx, manufactured by ev3, is a next
generation polymeric embolisation agent
designed for use in the embolisation of brain
arteriovenous malformations.
The composition and chemical characteristics of Onyx
are distinctly different from n-BCA products. Onyx is part
of the family of other artificial embolisation agents that
include particulate embolic agents, coils and balloons.
Onyx is a composition of ethylene vinyl alcohol copolymer
(EVOH) solution of dimethyl sulfoxide (DMSO) and
suspended micronized tantalum powder. DMSO is an
excellent solvent for the liquid delivery of EVOH, while
tantalum powder provides contrast for fluoroscopic
visualisation.
The DMSO solvent dissipates into the blood and
interstitial fluids, causing the EVOH copolymer and
suspended tantalum to precipitate in situ into a spongy,
coherent substance. Onyx immediately forms a skin and
solidifies from the outside to the inside.
Composition of Onyx
The different compostions of Onyx determine its
properties of viscosity/flow and the degree of visualization
when implanted in the vasculature. The numerical term of
Onyx describes its viscosity relative to flow.
Part
EVOH
Relative Viscosity
Onyx-18
6%
18
Onyx-20
6.5%
20
Onxy-34
8%
34
PEOPLE. IDEAS. PASSION.
Choosing the correct composition
Onyx 18 or Onyx 20 are generally chosen when nidal
position of the AVM can be achieved and for slow flow
feeders. Onyx 34 is designed for higher flow AVMs or
fistulous components.
In short, Onyx gives the physician the advantage of
control and timing over this complex procedure.
ev3 Europe SAS
16 rue Washington
75008 Paris
France
PH +33 (0) 156 88 59 10
FX +33 (0) 156 88 59 11
ev3 Inc.
9600 54th Avenue N.
Plymouth, MN
55442-2111 USA
PH +1 763 398 7000
FX +1 763 398 7001
Tollfree +800 716 6700
www.ev3.net
ev3 Benelux
PH +31 (0) 433 659 223
FX +31 (0) 433 650 283
ev3 France
PH +33 (0) 156 88 31 10
FX +33 (0) 156 88 31 11
ev3 Italy
PH +39 0331 781 212
FX +39 0331 780 499
ev3 Spain
PH +34 91 656 7154
FX +34 91 656 7214
ev3 International
Distribution Centre
Europalaan 25
6199 AB Maastricht-Airport
The Netherlands
PH +31 (0) 43 365 9228/9
FX +31 (0) 43 364 6395
ev3 Germany, Austria
PH +49 228 528 830
FX +49 228 528 8360
ev3 Nordic
PH +46 878 325 60
FX +46 878 325 69
ev3 United Kingdom
PH +44 1279 659 900
FX +44 1279 654 900
0120
Onyx, UltraFlow HPC, Marathon, Rebar, Silverspeed and Mirage are trademarks of Micro Therapeutics Inc. © 2005 Micro Therapeutics Inc.
10
75572 Rev B
BALLOONS • CATHETERS • COILS • EMBOLIC PROTECTION • GUIDEWIRES AND SNARES • LIQUID EMBOLICS • STENTS • THROMBUS MANAGEMENT
Onyx: technical facts
Onyx, manufactured by ev3, is a next
generation polymeric embolisation agent
designed for use in the embolisation of brain
arteriovenous malformations.
The composition and chemical characteristics of Onyx
are distinctly different from n-BCA products. Onyx is part
of the family of other artificial embolisation agents that
include particulate embolic agents, coils and balloons.
Onyx is a composition of ethylene vinyl alcohol copolymer
(EVOH) solution of dimethyl sulfoxide (DMSO) and
suspended micronized tantalum powder. DMSO is an
excellent solvent for the liquid delivery of EVOH, while
tantalum powder provides contrast for fluoroscopic
visualisation.
The DMSO solvent dissipates into the blood and
interstitial fluids, causing the EVOH copolymer and
suspended tantalum to precipitate in situ into a spongy,
coherent substance. Onyx immediately forms a skin and
solidifies from the outside to the inside.
Composition of Onyx
The different compostions of Onyx determine its
properties of viscosity/flow and the degree of visualization
when implanted in the vasculature. The numerical term of
Onyx describes its viscosity relative to flow.
Part
EVOH
Relative Viscosity
Onyx-18
6%
18
Onyx-20
6.5%
20
Onxy-34
8%
34
PEOPLE. IDEAS. PASSION.
Choosing the correct composition
Onyx 18 or Onyx 20 are generally chosen when nidal
position of the AVM can be achieved and for slow flow
feeders. Onyx 34 is designed for higher flow AVMs or
fistulous components.
In short, Onyx gives the physician the advantage of
control and timing over this complex procedure.
ev3 Europe SAS
16 rue Washington
75008 Paris
France
PH +33 (0) 156 88 59 10
FX +33 (0) 156 88 59 11
ev3 Inc.
9600 54th Avenue N.
Plymouth, MN
55442-2111 USA
PH +1 763 398 7000
FX +1 763 398 7001
Tollfree +800 716 6700
www.ev3.net
ev3 Benelux
PH +31 (0) 433 659 223
FX +31 (0) 433 650 283
ev3 France
PH +33 (0) 156 88 31 10
FX +33 (0) 156 88 31 11
ev3 Italy
PH +39 0331 781 212
FX +39 0331 780 499
ev3 Spain
PH +34 91 656 7154
FX +34 91 656 7214
ev3 International
Distribution Centre
Europalaan 25
6199 AB Maastricht-Airport
The Netherlands
PH +31 (0) 43 365 9228/9
FX +31 (0) 43 364 6395
ev3 Germany, Austria
PH +49 228 528 830
FX +49 228 528 8360
ev3 Nordic
PH +46 878 325 60
FX +46 878 325 69
ev3 United Kingdom
PH +44 1279 659 900
FX +44 1279 654 900
0120
Onyx, UltraFlow HPC, Marathon, Rebar, Silverspeed and Mirage are trademarks of Micro Therapeutics Inc. © 2005 Micro Therapeutics Inc.
10
75572 Rev B
BALLOONS • CATHETERS • COILS • EMBOLIC PROTECTION • GUIDEWIRES AND SNARES • LIQUID EMBOLICS • STENTS • THROMBUS MANAGEMENT