the correct size (see Information on size selection). The length of the p48 MW (HPC) must
be selected so that the implant covers the lesion at the distal and proximal ends by at least
a few millimetres.
12. Insert a suitable microcatheter with a corresponding microguidewire into the target vessel
using a hemostatic valve and pressurized irrigation. Here, the use of so-called "road map"
technology is advisable. Never probe against resistance! Aim to position the tip of the
microcatheter 10-15 mm distal to the treatment target.
Once the target vessel treatment segment has been reached, carefully pull on the
microcatheter in order to remove any excess catheter length and straighten the catheter.
13. Remove the microguidewire from the microcatheter under X-ray fluoroscopy.
14. Device preparation: Take the sterile device in its dispenser snail out of the packaging.
Release the proximal end of p48 MW (HPC) and pull it together with peel-away sheath out
of the dispenser snail.
15. With the aid of a tight-closing hemostatic valve and under continuous pressurized irrigation
with heparinized physiological saline solution, the p48 MW (HPC) is transferred from its
peel-away sheath into the microcatheter. For this purpose, the hemostatic valve is opened.
The peel-away sheath of the p48 MW (HPC) is inserted through the open valve. The
hemostatic valve is closed carefully and the peel-away sheath of the p48 MW (HPC) is
flushed by retrograde entry of the irrigation fluid.
16. Once the peel-away sheath of the p48 MW (HPC) is completely flushed in this manner,
it is advanced until it reaches the distal end of the hub adapter of the microcatheter. The
peel-away sheath is held fixed in this position. The p48 MW (HPC) is then advanced from
the peel-away sheath into the microcatheter using the transport tube to which the implant
is fixed. This process is continued until approx. 60 cm of the delivery system is inside the
microcatheter.
17. The peel-away sheath is then pulled back proximally as far as the handle on the transport
tube. Then the peel-away sheath is removed fully by carefully peeling it away. For this
purpose, a short tab is located on the proximal end of the peel-away sheath, which is pulled
back proximally over the handle at the transport tube thereby peeling-away the sheath
longitudinally. In the process, it is imperative to avoid kinking the delivery wire.
The process of inserting the p48 MW (HPC) generally corresponds to that of inserting other
similar implants. Should you encounter particular resistance which can only be overcome
with effort, the implant and possibly also the microcatheter must be removed and the vessel
accessed once more.
18. The p48 MW (HPC) is slowly advanced to the tip of the microcatheter under continuous
fluoroscopy. The distal tip of the delivery system should reach the tip of the microcatheter.
Never push the p48 MW (HPC) delivery system tip beyond the distal tip of the
microcatheter. This can lead to a dissection or perforation of the target vessel.
19. Release the implant fully by carefully and very slowly withdrawing the microcatheter up
to point that the implant can still be recovered back into the microcatheter. The point of
maximum implant deployment that allows for implant recovery is indicated by a platinum
marker at the distal end of the transport tube: As long as marker is located inside the
microcatheter the implant can be completely recovered.
Once the distal end of the implant is fully expanded and anchored in the distal vessel,
continue to deploy the implant by continuously pushing on the delivery system in order to
facilitate the expansion of the p48 MW (HPC). In order to ensure optimal wall apposition,
the deployment must be a coordinated effort of continuous pushing of the delivery system
and adjustments (advancing or withdrawing) of the microcatheter so that the microcatheter
is centralized longitudinally along the vessel. The release of the p48 MW (HPC) should
take place under fluoroscopy in order to ensure that the implant is properly deployed and
the distal end has not moved.
Please note that the distal delivery wire tip moves distally during implant
deployment. To counteract this movement and to avoid, e.g., the entry of the delivery
wire tip into distal sensitive vessels, the delivery wire tip can be moved proximally after
the torquer is released while the implant is not completely deployed. To do this the white
torquer at the proximal end of the delivery system is loosened and replaced by any
standard torquer (compatible with a 0.014 inch or 0.016 inch microguidewire); this torquer
is then locked more proximally to the end of the delivery wire. The delivery wire is then
withdrawn out of the transport tube. The transport tube has an additional handle at its
proximal end for easier handling.
20. The p48 MW (HPC) is self-expanding and, when properly deployed, apposes itself against
the vascular wall. The implant may over-expand at the neck of the aneurysm due to the
increased diameter at that point. Correct deployment can be verified by visualizing the
platinum-filled braiding wires of the implant.
21. Injecting approx. 6-10 ml of X-ray contrast medium through the guide catheter allows one
to check whether the aneurysm/dissection/target vessel has been satisfactorily covered by
the deployment and release of the p48 MW (HPC).
When using DSA systems with a digital detector and CT technology ("flat panel detector CT",
e.g. DynaCT [Siemens], XperCT [Philips]), the implant can be visualized on the sectional
image. This has proven particularly effective in the evaluation of the deployment and
apposition to the vessel wall.
22. If the radial deployment of the p48 MW (HPC) is insufficient or the position or the model
size selected is unsuitable, the p48 MW (HPC) can be recovered into the microcatheter, if
the distal marker of the transport tube is still inside the microcatheter, in order to allow the
implant to be repositioned, redeployed or completely removed.
If the delivery wire tip was moved proximally before, it must be ensured that the distal wire
tip is placed again distally to the distal compressed implant end and the white torquer is
locked again on the transport tube.
For repositioning or removal the microcatheter is advanced while the delivery system is
slowly withdrawn.
23. If the position and deployment of the p48 MW (HPC) are satisfactory, the implant is
immediately fully deployed and detached by complete withdrawal of the microcatheter.
The proximal implant end is thus exposed and it can fully expand. Due to the radial
expansion of the proximal end, a slight shortening of the implant takes place!
24. Remove the delivery system by gently withdrawing.
25. Insufficient deployment of the p48 MW (HPC) can be improved by means of a subsequent
balloon dilatation. As far as possible, the p48 MW (HPC) should appose against the
vascular wall.
26. After the first p48 MW (HPC) is detached, if a subsequent telescoping device is required,
gently advance the microcatheter through the p48 MW (HPC). When the microcatheter
tip is distal to the p48 MW (HPC), gently retract the wire tip into the microcatheter and
remove the delivery system completely out of the microcatheter. The microcatheter is now
in position for a subsequent p48 MW (HPC) to be advanced and deployed.
27. Injecting approx. 6-10 ml of X-ray contrast medium through the guide catheter allows one
to check once more, if necessary, whether the target vessel has been sufficiently covered
by the application of the p48 MW (HPC). This check should be repeated 10 to 15 minutes
later where necessary.
28. Take steps to ensure adequate inhibition of platelet aggregation. Proven medications
following implantation include a 100 mg oral dose of ASA every day on an ongoing basis
and a 75 mg oral dose of clopidogrel every day for at least 12 months, but longer when
necessary or on an ongoing basis.
Be mindful of possible interactions with other medications (e.g. with proton pump inhibitors,
Ibuprofen, Metamizole).
In vitro test results and initial clinical experience demonstrate that the version p48 MW HPC
can provide a reduced surface thrombogenicity. In justified exceptional cases, the reduced
thrombogenicity can allow the implantation under single antiplatelet medication, only if no
reasonable alternative therapy is given. Here particular attention is to be paid to at leat
three days medication prior to treatment. The achieved platelet inhibition is more intensive
by using P2Y12 inhibitors (Prasugrel, Ticagrelor) than by using ASA.
For safety reasons, the efficacy of the antiplatelet medication is always to be verified by
means of appropriate tests (e.g. Multiplate, VerifyNow, PFA).
Information on the selection of patients and lesions
If compliance to the antiplatelet medication described above cannot be guaranteed following
the implantation of a p48 MW (HPC), thrombotic closure of the implant and the vessel around
it may occur within just a few days. Patients who cannot comply with the prescribed medication
may not be suitable for treatment with a p48 MW (HPC).
From the time of implantation of a p48 MW (HPC), several weeks or months may pass before
an aneurysm is no longer a risk. In this period, no complete protection from a (fresh) rupture/
bleed can be guaranteed. Therefore, patients who are in the acute phase post aneurysm
rupture should be treated by options that offer greater protection from re-rupture/bleed.
Information on size selection
•
Select the implant diameter so that the deployed diameter comes as close as possible to the
target vessel diameter, in order to achieve proper vessel wall apposition.
•
Do not use the implant in target vessels whose diameter is not within the range of
application specified on the packaging.
•
Caution: Substantial oversizing (selection of a p48 MW (HPC) with a range of application
considerably above the diameter of the target vessel) poses the risk of incorrect deployment
(incomplete expansion).
•
Caution: Undersizing (selection of a p48 MW (HPC) with a range of application below the
diameter of the target vessel) leads to insufficient fixation of the p48 MW (HPC) within the
vessel and allows blood to flow around the outside of the implant (a so-called "endoleak").
The implant is then unstable, is subject to migration and hemodynamically ineffective.
•
Ensure that the implant overlaps the lesion distally and proximally. If the selected product is
too short or too long, it can be removed and replaced with a suitable one.
•
Ensure that the implant does not end proximally in a narrow vessel curve because this may
constrain a full proximal expansion. Choose an implant length which results in a complete
coverage of the proximal vessel curve by the p48 MW (HPC).
Precautions
•
The p48 MW (HPC) may be deployed up to three (3) times in the target vessel. It must be
considered that each deployment only occurs up to the point that the distal marker of the
transport tube is still inside the microcatheter!
•
For flushing place the peel-away sheath of the p48 MW (HPC) inside the hemostatic valve
of the microcatheter and flush it by the help of the connected irrigation fluid. Thorough
flushing of the peel-away sheath is essential in order to remove any trapped air bubbles.
•
All manipulations must be carried out under fluoroscopic visualization.
•
If the p48 MW (HPC) system is advanced beyond the distal end of the microcatheter, the
vessel may be dissected or perforated.
•
If the p48 MW (HPC) system can be advanced into the microcatheter only with great effort or
navigated through the microcatheter only with great effort, remove the entire p48 MW (HPC)
system out of the microcatheter as a precaution.
•
Do not pull the deployed implant back through the vessel into the microcatheter. Instead,
push the microcatheter over the p48 MW (HPC) while simultaneously fixating the delivery
system to reposition and redeploy the implant if necessary.
B842B p48 MW IFU / 2018-07-16
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