Excelsior® - CMO Ortopedia

Excelsior® SL-10® and Excelsior 1018® Preshaped Microcatheter
See package insert for complete indications,
contraindications, warnings and instructions for
use.
Selection Guide
Excelsior® SL-10® Microcatheters
Description
Total/
Distal Length
M0031681890
Straight, 2-tip marker
150cm/6.0cm
M0031681900
Pre-Shaped 45, 2-tip marker
150cm/6.0cm
M0031681910
Pre-Shaped 90, 2-tip marker
150cm/6.0cm
M0031681920
Pre-Shaped J, 2-tip marker
150cm/6.0cm
M0031681930
Pre-Shaped C, 2-tip marker
150cm/6.0cm
M0031681940
Pre-Shaped S, 2-tip marker
150cm/6.0cm
M0031681810
Straight, 1-tip marker
150cm/6.0cm
Material Number
Braided
Hydrophilic
Proximal/
Distal OD
Proximal/
Distal ID
2.4F/1.7F
0.79mm/0.56mm
.0165in/.0165in
0.42mm/0.42mm
Braided
Hydrophilic
Proximal/
Distal OD
Proximal/
Distal ID
2.6F/2.0F
0.87mm/0.67mm
.019in/.019in
0.48mm/0.48mm
INTENDED USE / INDICATIONS FOR USE
Stryker Neurovascular Excelsior SL-10 Pre-Shaped
Microcatheter and Excelsior 1018 Pre-Shaped Microcatheter
are intended to assist in the delivery of diagnostic agents,
such as contrast media, and therapeutic agents, such
as occlusion coils to the peripheral, coronary, and neuro
vasculature.
CONTRAINDICATIONS
None known.
POTENTIAL ADVERSE EVENTS
Please notify your Stryker Neurovascular representative
immediately by telephone or FAX if a device malfunctions or
patient complication or injury is experienced or suspected
associated with the use of this device. Please make
every attempt to retain any suspect device, its associated
components and their packaging for return to Stryker
Neurovascular.
Potential adverse events associated with the use of
microcatheters or with the endovascular procedures include,
but are not limited to: access site complications, allergic
reaction, aneurysm perforation, aneurysm rupture, death,
embolism (air, foreign body, plaque, thrombus), hematoma,
hemorrhage, infection, ischemia, neurological deficits,
pseudoaneurysm, stroke, transient ischemic attack, vessel
dissection, vessel occlusion, vessel perforation, vessel
rupture, vessel thrombosis, vasospasm.
Recommended Guidewire Diameter: .014in (.36mm)
Minimum Guide Catheter ID: .038in (.97mm)
Excelsior® 1018® Microcatheters
Description
Total/
Distal Length
M0031441890
Straight, 2-tip marker
150cm/6.0cm
M0031441900
Pre-Shaped 45, 2-tip marker
150cm/6.0cm
M0031441910
Pre-Shaped 90, 2-tip marker
150cm/6.0cm
M0031441920
Pre-Shaped J, 2-tip marker
150cm/6.0cm
M0031441930
Pre-Shaped C, 2-tip marker
150cm/6.0cm
M0031441940
Pre-Shaped S, 2-tip marker
150cm/6.0cm
M0031441810
Straight, 1-tip marker
150cm/6.0cm
Material Number
WARNINGS
•Contents supplied STERILE using an ethylene oxide (EO)
process. Do not use if sterile barrier is damaged. If damage
is found, call your Stryker Neurovascular representative.
•For single patient use only. Do not reuse, reprocess or
resterilize. Reuse, reprocessing or resterilization may
compromise the structural integrity of the device and/
or lead to device failure which, in turn, may result in
patient injury, illness or death. Reuse, reprocessing or
resterilization may also create a risk of contamination of
the device and/or cause patient infection or crossinfection,
including, but not limited to, the transmission of infectious
disease(s) from one patient to another. Contamination
of the device may lead to injury, illness or death of the
patient.
•After use, dispose of product and packaging in accordance
with hospital, administrative and/or local government
policy.
•These devices are intended for use only by
physicians trained in performing endovascular
procedures.
•The accessories are not intended for use inside the human
body.
•Limited testing has been performed with solutions
such as contrast media, saline and suspended embolic
particles. The use of these microcatheters for delivery of
solutions other than the types that have been tested for
compatibility is not recommended. Do not use with glue or
glue mixtures.
•Carefully inspect all devices prior to use. Verify shape, size
and condition are suitable for the specific procedure.
•Exchange microcatheters frequently during lengthy
procedures that require extensive guidewire manipulation
or multiple guidewire exchanges.
•Never advance or withdraw an intravascular device
against resistance until the cause of the resistance is
determined by fluoroscopy. Movement of the microcatheter
or guidewire against resistance could dislodge a clot,
perforate a vessel wall, or damage microcatheter
and guidewire. In severe cases, tip separation of the
microcatheter or guidewire may occur.
•Inspect product before use for any bends, kinks or damage.
Do not use a microcatheter that has been damaged.
Damaged microcatheters may rupture causing vessel
trauma or tip detachment during steering maneuvers.
•Shaping mandrel is not intended for use inside the human
body. Discontinue use of the microcatheter for infusion
if increased resistance is noted. Resistance indicates
possible blockage. Remove and replace the blocked
microcatheter immediately. DO NOT attempt to clear
blockage by over-pressurization. Doing so may cause the
microcatheter to rupture, resulting in vascular damage or
patient injury.
•Do not exceed maximum infusion pressure indicated for
each microcatheter family in Table 2. Excessive pressure
could dislodge a clot, causing thromboemboli, or severed
tip, causing vessel injury.
CAUTIONS / PRECAUTIONS
•Federal Law (USA) restricts this device to sale by or on the
order of a physician.
•Exercise care in handling of the microcatheter during a
procedure to reduce the possibility of accidental breakage,
bending or kinking.
•To reduce the probability of coating damage in tortuous
vasculature, use a guide catheter with a minimum internal
diameter that is ≥ 1.00 mm (0.038 in) and is recommended
for use with Stryker Neurovascular hydrophilically coated
microcatheters.
•To control the proper introduction, movement, positioning
and removal of the microcatheter within the vascular
system, users should employ standard clinical angiographic
and fluoroscopic practices and techniques throughout the
interventional procedure.
•Flush dispenser coil of hydrophilically coated
microcatheters prior to removal from dispenser coil. Once
the microcatheter has been wetted, do not allow to dry. Do
not reinsert the microcatheter into dispenser coil.
•The packaging mandrel is not intended for reuse. The
packaging mandrel is not intended for use inside the
human body.
•Do not position Pre-Shaped Microcatheter closer than
2.54 cm (1 inch) from the steam source. Damage to the
Pre- Shaped Microcatheter may result.
•Check that all fittings are secure so that air is not
introduced into guide catheter or microcatheter during
continuous flush.
•In order to achieve optimal performance of Stryker
Neurovascular Microcatheters and to maintain the
lubricity of the Hydrolene® Coating surface, it is critical
that a continuous flow of appropriate flush solution
be maintained between the Stryker Neurovascular
Microcatheter and guide catheter, and the microcatheter
and any intraluminal device. In addition, flushing aids in
preventing contrast crystal formation and/or clotting on
both the intraluminal device and inside the guide catheter
and/or the microcatheter lumen.
•Excessive tightening of a hemostatic valve onto the
microcatheter shaft may result in damage to the
microcatheter.
•To facilitate microcatheter handling, the proximal portion
of the microcatheter does not have the hydrophilic surface.
Greater resistance may be encountered when this section
of the microcatheter is advanced into the RHV.\
Excelsior®
MICROCATHETERS
Proven Performance
Recommended Guidewire Diameter: .014in (.36mm)
Minimum Guide Catheter ID: .046in (1.20mm)
RAQA Manager
Stryker France S.A.S.
ZAC-Avenue de Satolas Green
69330 Pusignan
France
Copyright © 2014 Stryker
90644008.AC
Stryker Neurovascular
47900 Bayside Parkway
Fremont, CA 94538-6515
stryker.com/neurovascular
stryker.com/emea/neurovascular
Date of Release: JAN/2014
EX_EN_GL
0344
Stroke: Our Only Focus. Our Ongoing Promise.
Excelsior®
MICROCATHETERS
High Performance Access and Delivery
•Excellent Versatility
Exceptional Versatility
Broad Compatibility
Excelsior ® SL-10® Microcatheter
Excelsior ® 1018® Microcatheter
1.7F (0.56mm) Low Profile Distal Shaft
Excelsior SL-10 Microcatheter tip is designed with low profile to
enhance access to distal vasculature and facilitates passage of the
catheter tip through stent interstices.
Thin-Wall Large Lumen*
Designed to provide a stable platform for coil deployment. The thin-wall
large ID Excelsior 1018 Microcatheter facilitates delivery of large coils.
•Optimized Flexibility and Trackability
•Outstanding Support
Large .0165in (0.42mm) Inner Lumen
Designed for broad device compatibility, the Excelsior SL-10
Microcatheter is the first choice for Matrix®, Target ®, and
GDC ® -10 Detachable Coils, and accommodates .010in and
.014in guidewires.
•Proven Delivery Performance
Products Features
Variety of Tip Shapes
Offered in well-thought and clinically relevant shapes,
which provides convenience and flexibility for access.
• Thin-Wall Technology
• Lubricious Hydrolene® Outer Surface
Excelsior® 1018®
10-coils
14-coils
10-coils
14-coils
18-coils
18-fibered
.0165in/0.42mm
.019in/0.48mm
1.7F/2.4F
0.56mm/0.79mm
2.0F/2.6F
0.67mm/0.87mm
Compatibility
ID
OD (Dist/Prox)
Distal Segment
Construction
Seamless Mid-Shaft
Braid Transition
Proximal Shaft
Construction
Stainless-steel helical-coil
reinforcement provides
lumen integrity. A soft,
low-durometer distal
segment is designed to be
flexible and atraumatic.
Proximal braiding transitions
seamlessly into distal helical
coil reinforcement to facilitate
advancement within tortuous
anatomy and allow smooth
deployment of embolic coils.
The proximal shaft features
three layers of stainlesssteel braid which, along with
a high-durometer proximal
shaft, provides support,
control, and pushability.
Variety of Tip Shapes
Offered in six different well-thought and clinically relevant shapes,
which provides convenience and flexibility for access.
Used to align the coil
delivery wire within the
microcatheter prior to coil
detachment, the proximal
marker band is precisely
located on the shaft body for
predictable coil detachment.
Versatile Microcatheter Options
Excelsior® SL-10®
Supportive Distal Shaft
The ultra-supportive distal shaft features stainless-steel helical-coil
reinforcement providing lumen integrity. A soft, low-durometer tip is
designed to be exceptionally soft and atraumatic.
Precisely Located
Proximal Marker
• Smooth TFE Inner Lumen
Occlusion Coil
2.0F (0.67mm) Low Profile Distal Shaft
The Excelsior 1018 Microcatheter is engineered with a composite shaft
construction for outstanding stability, pushability, and lumen integrity
while having a smaller Distal OD compared to a leading competitor.**
Atraumatic Distal Tip
Specifically engineered for atraumatic access, the rounded,
low-durometer, unbraided tip offers excellent softness and flexibility.
Radiopaque Marker Band
Highly radiopaque, platinum
marker band distally and proximally
provides superb visualization.
Available
in Six Shapes
Transparent Hub
A transparent polymer hub
allows guidewires, coils, and
embolic agents to be introduced
under direct visualization.
C
S
45
90
J Straight
*Largest in the Excel families of Microcatheter compatible
with 10-coils, 14-coils, 18-coils, 18-fibered
**Prowler™ Select Plus.
Prowler is a trademark of Codman & Shurtleff, Inc.

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