a . Unconstrained Width [Aneurysm Width (Dome)])
b
b . Unconstrained Height [Aneurysm Height]
a
c . 15% Constrained Width [Aneurysm Width (Dome)])
d
c
d . 15% Radial Compression Height [Aneurysm Height]
15%
a . Unconstrained Width [Aneurysm Width (Dome)])
b
b . Unconstrained Height [Aneurysm Height]
a
c . 15% Constrained Width [Aneurysm Width (Dome)])
d
c
d . 15% Radial Compression Height [Aneurysm Height]
15%
B .
Place the microcatheter to gain access to the aneurysm .
C .
Ensure a rotating hemostatic valve (RHV) is attached to the hub of the
microcatheter, attach a one-way stopcock to the sidearm of the RHV and
connect the flush solution line to the stopcock .
NOTE: It is recommended to use a heparinized saline drip to continuously flush
microcatheter during Artisse™ intrasaccular device loading and use .
3.
Artisse
™
Intrasaccular Device Preparation:
A .
Selecting an appropriately-sized Artisse™ intrasaccular device, after inspecting
the package for damage to the sterile barrier, peel open the pouch using
aseptic technique and remove the dispenser coil from its protective packaging
within a sterile field .
B .
Unclip the proximal pusher wire from the dispenser coil . Following the arrow
on the package, push on the proximal end of the delivery wire until the
implant and introducer exits the dispenser coil . Hold the delivery wire and
introducer together while continuing to remove the entire device from the
dispenser coil .
C .
With the implant already outside of the introducer sheath, visually verify shape
and integrity of the unconstrained implant, inspecting for any damage . Do not
use the device if there is any damage or if the implant is detached .
D .
Pull the delivery wire and carefully sheath and capture the entire implant
within the introducer . Then carefully place the distal end of the introducer fully
into the heparinized saline bowl . Slowly deploy the implant completely into
the heparinized saline solution, ensuring that the implant and introducer are
completely submerged and fully hydrated . Check for the following:
1 . Implant opening uniformly .
2 . Implant tracks smoothly through the introducer .
3 . Confirm that the introducer tip is not damaged and the delivery wire is
not kinked .
WARNING
•
Do not continue procedure if any defect is observed .
E .
Keeping the Artisse™ implant and introducer tip completely submerged and
fully hydrated in the heparinized saline and minimizing any visible air bubbles,
carefully pull back on the delivery wire and recapture the Artisse
fully hydrating the implant . Verify the entire implant is recaptured within the
introducer sheath .
F .
Repeat steps E and F as needed .
4.
Introduction of the Artisse
Intrasaccular Device:
™
4 . 5 mm
5 . 0 mm
5 . 4 mm
6 . 0 mm
3 . 8 mm
4 . 3 mm
6 . 1 mm
6 . 8 mm
Table 1a: Size Recommendation for Spheroid Shape
4 . 5 mm
5 . 0 mm
5 . 6 mm
6 . 3 mm
3 . 8 mm
4 . 3 mm
6 . 6 mm
7 . 4 mm
Table 1b: Size Recommendation for Flared Shape
A .
Partially insert the introducer sheath into the RHV with a continuous
heparinized saline flush at the catheter hub and tighten the RHV locking ring .
Flush the y-connector of the RHV and confirm liberal backflush and de-airing as
fluid exits the proximal end of the introducer sheath . After visually confirming,
untighten the RHV, advance the tip of the introducer sheath completely into
the RHV, engaging it with microcatheter hub and tighten the RHV locking ring .
Confirm that there are no air bubbles trapped in the system .
NOTE: It is recommended to use a heparinized saline drip to continuously flush
microcatheter during Artisse™ intrasaccular device loading and use .
B .
To avoid microcatheter kickout from the aneurysm, visually verify proper
location of the distal tip of the delivery microcatheter within the aneurysm
as the implant is being loaded and tracked through the hub and within the
microcatheter .
WARNING
•
If high forces or excessive friction is encountered during delivery, discontinue
delivery of the device and identify the cause of the resistance, remove device and
microcatheter simultaneously . Advancement of the Artisse™ intrasaccular device
against resistance may result in damage or patient injury .
CAUTION: The introducer must be properly engaged with the microcatheter hub
to enable the Artisse™ intrasaccular device introduction through the hub
and the microcathether . Stop and verify if any undue friction or resistance is
experienced . If continued resistance is encountered during implant delivery,
withdraw and select a new device .
C .
Advance the proximal end of delivery wire until it aligns with proximal end
of introducer sheath . Loosen the RHV locking ring and remove the introducer
sheath .
CAUTION: Failure to remove the introducer sheath after inserting the delivery wire
into the RHV of the microcatheter will interrupt normal infusion of flush
solution and allow back flow of blood into the microcatheter .
NOTE: Fluoroscopy may be used up to this point at physician discretion . The fluorosafe
marker is only compatible with microcatheters with a minimum length of
135cm .
D .
Carefully advance the Artisse™ intrasaccular device until the fluorosafe marker
approaches the RHV [Figure 1b] . At this time, fluoroscopy must be initiated .
implant,
™
E .
Continue advancing the Artisse™ intrasaccular device through the
microcatheter by pushing the delivery wire until the distal portion of the
radiopaque implant aligns with the distal tip of the microcatheter .
CAUTION: Do not use a torque delivery device during or after delivery of the Artisse™
intrasaccular device . Rotating the Artisse delivery wire may result in a stretched
implant or premature detachment of the implant within the microcatheter .
Spheroid Shape
5 . 5 mm
6 . 0 mm
6 . 5 mm
6 . 6 mm
7 . 2 mm
7 . 8 mm
4 . 7 mm
5 . 1 mm
5 . 5 mm
7 . 4 mm
8 . 2 mm
8 . 6 mm
Flared Shape
5 . 5 mm
6 . 0 mm
6 . 5 mm
6 . 9 mm
7 . 5 mm
8 . 1 mm
4 . 7 mm
5 . 1 mm
5 . 5 mm
8 . 0 mm
8 . 8 mm
9 . 4 mm
4
7 . 0 mm
8 . 0 mm
Labeled Width and Height (mm) per Product Label
8 . 4 mm
9 . 6 mm
Ensure Labeled Width Size is Equal to or Greater Than the
Measured Average Aneurysm Width (Dome)
6 . 0 mm
6 . 8 mm
Resultant Reference Width and Height (mm) After 15%
9 . 5 mm
10 . 8 mm
7 . 0 mm
8 . 0 mm
Labeled Width and Height (mm) per Product Label
8 . 8 mm
10 . 0 mm
Ensure Labeled Width Size is Equal to or Greater Than the
Measured Average Aneurysm Width (Dome)
6 . 0 mm
6 . 8 mm
Resultant Reference Width and Height (mm) After 15%
10 . 4 mm
12 . 0 mm
NOTE: Verify proper location of the distal tip of the delivery microcatheter within the
aneurysm as the implant is being loaded and tracked within the microcatheter .
5.
Positioning and Deployment of the Artisse
A .
Once the distal portion of the radiopaque implant aligns with the distal tip of
the microcatheter, verify that the microcatheter is in the desired location .
B .
Under fluoroscopic guidance, deploy the Artisse™ implant using a combination
of slowly unsheathing the delivery microcatheter and pushing the delivery
wire simultaneously into the lesion until optimal deployment is achieved .
Reposition as needed:
1 . Maintain visualization of the implant and microcatheter as the implant
self-expands .
2 . Use gentle pulling on the microcatheter as well as gentle forward pressure
on the microcatheter to unsheath the implant until it is in contact with
the aneurysm wall .
CAUTION: Do not use a torque delivery device during positioning or deployment of
the Artisse™ intrasaccular device .
NOTE: The implant can be fully recaptured within the microcatheter up to 3 times .
NOTE: A proper push/pull technique, encompassing sufficient delivery wire push
force, in addition to an opposing microcatheter withdrawing force to keep
the implant loaded, will facilitate properly deploying the Artisse™ implant
to achieve full opening, good aneurysm wall compliance and neck coverage .
Slowly advancing the Artisse™ implant outside the microcatheter tip, while
adjusting microcatheter position will help ensure accurate deployment within
the aneurysm . Maintain simultaneous control of the Artisse™ intrasaccular
device and microcatheter in order to position and expand the device at the
proper location .
3 . To minimize the potential risk of emboli, do not allow an inappropriately
sized or positioned implant to reside in the aneurysm beyond the
activated clotting time (ACT) . Retract the implant into the microcatheter
and either reposition the microcatheter to reposition/redeploy or remove
and replace with another device .
4 . If implant size is not appropriate, remove and replace with an
appropriately sized device .
5 . If implant position is unsatisfactory, it can be repositioned prior to
detachment .
6 . To reposition or remove implant, slowly pull back on the delivery wire and
slowly advance the microcatheter as needed to fully recapture the implant
within the microcatheter .
7 . If undesirable movement of the implant is noted during positioning of
the implant or repositioning cannot be completed as required, remove
implant together with delivery system as a unit .
Note:
Radial Compression
Note:
Radial Compression
™
Intrasaccular Device: