Stryker Surpass Evolve Mode D'emploi page 5

note: The device diameter should be chosen based on the measurements of
the vessel size proximal to the intracranial aneurysm neck.
2. Choose a Surpass Evolve™ Flow Diverter System with a labeled length that
is at least 10mm longer than the intracranial aneurysm neck (to maintain a
minimum of 5mm on either side of the neck) and allows for the proximal and
distal ends of the implant to land in a straight section of the vessel.
note: The implant changes in length during deployment, referred to as
foreshortening. Take this into account when deploying (table 2). The implant
deployed length will never be shorter than its labeled length, in its indicated
vessel diameter, even after foreshortening.
table 2. Device Deployed length changes*
Device Diameter (mm)
2.5
3.25
4.0
4.5
5.0
*Based on mathematical calculations
Flow Diverter positioning
1. Using conventional catheterization technique, place the microcatheter tip at
least 20mm past the distal neck of the intracranial aneurysm. It is recommended
to use a heparinized saline drip to continuously flush the microcatheter during
the procedure.
2. Remove the guidewire from the microcatheter.
3. Remove the Surpass Evolve Flow Diverter System packaging hoop from the
pouch and pull the proximal end of the introducer sheath from the white clip
on the packaging hoop. Carefully remove system from the packaging hoop.
note: Hold the introducer sheath and delivery wire together when removing
the system from the packaging hoop to avoid premature deployment.
4. Inspect the system for any damage. Confirm that the implant and delivery wire
are properly pre-loaded in the distal tip of the introducer sheath.
5. Partially insert the distal tip of the introducer sheath into the microcatheter
RHV and tighten the RHV.
note: Under-tightening or over-tightening the RHV may result in inadequate
flushing.
6. Using an appropriately pressurized sterile flush or syringe, confirm that fluid
exits the proximal end of the introducer sheath prior to advancing the system
into the microcatheter.
warning: Confirm that there are no air bubbles in the system.
7. Loosen the RHV, advance the introducer sheath into the RHV and visually confirm
the tip of the sheath is seated deeply in the hub of the microcatheter. Tighten the
RHV firmly to secure the introducer sheath to the hub of the microcatheter.
average decrease in length from
inside Delivery system to fully
expanded (%)
38
35
49
52
58
8. Advance the delivery wire to transfer the implant from the introducer sheath
into the microcatheter.
9. Continue to advance the system until the distal edge of the fluoro saver
marker enters the proximal end of the introducer sheath.
10. Loosen the RHV on the microcatheter and remove the introducer sheath,
holding the delivery wire in place. Re-tighten the RHV as needed. If desired,
place a torque device on the proximal end of delivery wire to facilitate
advancement through the microcatheter and deployment.
caution: Use the torque device when advancing the delivery wire only. Do not
use the torque device to torque the delivery wire as it is not designed to be
torqued and it may result in system damage.
11. Slowly advance the delivery wire until the distal edge of the fluoro saver
marker reaches the microcatheter RHV. The fluoro saver marker is located
125cm from the distal tip of the delivery wire.
warning: The fluoro saver marker is only compatible with microcatheters with
a minimum length of 135cm. Usage of shorter microcatheters could result in
inadequate working length for the operator and unintentional deployment of
the implant.
12. Under fluoroscopic visualization, continue to advance the system through
the microcatheter until the distal radiopaque marker on the delivery wire is at
least 5mm beyond the neck of the intracranial aneurysm.
13. Confirm the position of the implant by visualizing the distal and proximal
radiopaque markers on the delivery wire. Ensure the distal end of the implant
is at least 5mm beyond the neck of the intracranial aneurysm.
note: Pulling back on the microcatheter to make final adjustments will ensure
that slack has been removed from the system prior to deployment.
14. Adjust RHV tightness just enough to allow free movement between the
microcatheter and delivery wire. The Surpass Evolve Flow Diverter is now
ready to be deployed.
Flow Diverter Deployment
1. Begin deployment by retracting the microcatheter while putting slight forward
pressure on the delivery wire until the implant begins to exit the microcatheter
and starts apposing to the vessel wall.
warning: Once the implant has begun to appose the vessel walls, do not attempt
to move the implant more distally as damage to the implant ends may occur.
2. A combination of forward pressure (pushing) on the delivery wire and/or
retracting the microcatheter (unsheathing) should enable the operator to keep
the distal end of the implant aligned at the desired landing zone as well as
achieve optimal vessel wall apposition.
note: During deployment, wall apposition may be improved by:
• Resheathing the implant and/or manipulation of the microcatheter by
locking down the delivery wire using the RHV and gently advancing both
the delivery wire and the microcatheter as a system (loading); and/or
• Maintaining the microcatheter tip within the center of the parent vessel.
5
Black (K) ∆E ≤5.0