Stryker Neuroform Atlas Instrucciones De Uso página 2

Neuroform Atlas
Stent System
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a
physician.
warnInG
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 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 cross-infection, 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.
resale of this device is prohibited by law.
DevICe DesCrIptIon
The Neuroform Atlas Stent System includes:
• A self-expanding, open-cell, nitinol stent with flared ends and three
radiopaque markerbands on each end (proximal and distal) and four
interconnects between the central stent segments, designed to provide
support of the coil mass within the aneurysm and minimize stent deflection.
• A stent delivery wire and introducer sheath. The stent is pre-loaded on the
stent delivery wire and protected by an introducer sheath.
• The stent delivery wire comes in two configurations: 1. With an 8.5 mm
distal tip, 2. Without a distal tip. Select a configuration based upon physician
preference.
• An accessory pouch containing an optional torque device. The physician
may attach the torque device to the proximal end of the stent delivery wire to
facilitate handling and stabilization. The stent delivery wire is not designed to
be torqued.
Contents
One (1) Neuroform Atlas Stent System
One (1) Torque Device
required accessories
Standard interventional devices, including rotating hemostatic valves ≥4.5F,
a guide catheter, guidewire(s), and Stryker Neurovascular 0.0165-0.017 in
(0.42-0.43 mm) ID microcatheters, excluding Tracker™ 17.
Black (K) ∆E ≤5.0
™
Introducer Sheath
Radiopaque Tip
Figure 1: neuroform atlas stent system with 8.5 mm tip
Introducer Sheath
Figure 2: neuroform atlas stent system without tip
table 1. sizing table
Labeled stent Diameter
Select a stent diameter based on the sizing recommendations in Table 1 and based on the larger vessel
1
diameter (proximal or distal reference vessel diameter).
IntenDeD Use/InDICatIons For Use
The Neuroform Atlas Stent System is intended to be used with occlusive devices
in the treatment of intracranial aneurysms.
ContraInDICatIon
• Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated.
• Patients for whom angiography and other examinations show that access
to the target cerebral aneurysm by the stent may be impossible because
of anatomical features, or severe vascular spasm that does not respond to
pharmacological therapy.
warnInGs
• This device should only be used by physicians who have received appropriate
training in interventional neuroradiology or interventional radiology and
preclinical training on the use of this device as established by Stryker
Neurovascular.
• Select a stent size (length) to maintain a minimum of 4 mm on each side of the
aneurysm neck along the parent vessel (see Table 2 for size information). An
incorrectly sized stent may result in damage to the vessel or stent migration.
2
Distal Tip
8.5mm
Distal Bumper
Stent
135 cm
Distal Bumper
Stent
Radiopaque Tip
Unconstrained stent
(mm) Diameter (mm)
3.0 3.5
4.0 4.5
4.5 5.0
Proximal Bumper Fluoro Saver Mark
185 cm
Stent Delivery Wire
Fluoro Saver Mark
Proximal Bumper
135 cm
185 cm
Stent Delivery Wire
recommended parent
vessel Diameter (mm)
1
≥2.0 and <3.0
≥3.0 and <4.0
≥4.0 and ≤4.5