Product Description - phenox p48 MW Mode D'emploi

ENGLISH
INSTRUCTIONS FOR USE
Manufacturer
phenox GmbH
Lise-Meitner-Allee 31
44801 Bochum, Germany
Phone: +49 234 36 919 0
Fax: +49 234 36 919 19
Package contents
1 x p48 MW (HPC) Flow Modulation Device (of version p48 MW or p48 MW HPC)

Product description

Fig. 1: p48 MW (HPC) implant and delivery system in peel-away sheath
Fig. 2: Delivery system and detached p48 MW (HPC) implant
Please note that in the following text the term p48 MW (HPC) stands for all device versions,
p48 MW (uncoated) and p48 MW HPC (coated).
The p48 MW (HPC) Flow Modulation Device is a tubular vascular implant that consists of

48 interwoven Nitinol wires which are filled with a platinum core to ensure visibility under
X-ray fluoroscopy.
The HPC coating (HPC: Hydrophilic Polymer Coating) of version p48 MW (HPC) covers the
entire implant  and reduces the initial adherance of thrombocytes and lowers so the risk of
thrombus generation.

The delivery system has a platinum marker

and another one at the distal wire tip

The attachment of the implant to the delivery system
The proximal end of the implant  is secured between a soft polymer pad (at the distal end of

the transport tube ) and a peel-away introducer sheath
function is performed by the microcatheter), in such a way that pushing and pulling of the implant
 is enabled.
The product is stored in a peel-away sheath
inside diameter of 0.021 inches (here: TrevoPro18, Stryker Neurovascular, USA). This sheath

is peeled away during insertion of the p48 MW (HPC) to enable complete passage through
the microcatheter.
The implant  self-expands as it leaves the microcatheter. Until it has been fully deployed in

the target vessel, the implant can be completely recovered back into the microcatheter to
allow it to be repositioned or removed. The point of maximum implant deployment that allows
for implant recovery is indicated by a platinum marker
 
tube : As long as the marker is located inside the microcatheter the implant
completely recovered.
The p48 MW (HPC) is always deployed by means of a coordinated movement, whereby the
microcatheter is withdrawn and the delivery system
the distal implant end by the shortening effect. Due to the shortening effect, the distal delivery wire

tip moves distally during deployment. To counteract this movement in order to avoid, e.g., the
entry of the delivery wire tip  into distal sensitive vessels, the delivery wire tip

proximally after the torquer is released prior to the implant
do this the white torquer  at the proximal end of the delivery system
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
 is then withdrawn out of the transport tube
handle  at its proximal end for easier handling.
The implant  is always recovered back into the microcatheter by means of a coordinated
movement, whereby the microcatheter is advanced and the delivery system is withdrawn.
All manipulations are carried out under X-ray visualization.
After final control of deployment and position, the implant

detached from the delivery system by withdrawal of the microcatheter.
Intended use
The p48 MW (HPC) Flow Modulation Device is a self-expanding, tubular vascular implant and
allows the controlled and selective modulation of blood flow in extra- and intracranial arteries.
In addition, the physical properties of the p48 MW straighten the target vessel slightly and
reinforce it.
These properties aid the endovascular reconstruction of diseased arteries along their cervical
and intracranial course.
6 B842B p48 MW IFU / 2018-07-16

at the distal end of the transport tube

to allow the operator to determine its position.

follows the friction locking principle:

(after removal of the sheath, the
 and is transferred into a microcatheter with an
 at the distal end of the transport
 is advanced to avoid any movement of


being completely deployed. To
 is loosened and

. The delivery wire
 . The transport tube  has an additional
 is completely deployed and
Indications
The p48 MW (HPC) Flow Modulation Device is a self-expanding, tubular implant and is used in
the endovascular treatment of vascular diseases such as
- saccular and fusiform aneurysms and pseudoaneurysms,
- vascular dissections in the acute and chronic phases and
- vascular perforations and AV fistulae.
Contraindications
Treatment is contraindicated in patients:
- in whom antiplatelet and/or anticoagulation therapy is contraindicated or antiplatelet therapy
did not start in a timely manner prior to treatment,
- in whom angiography demonstrates the anatomy is not appropriate for endovascular
treatment, such as severe vessel tortuosity or stenosis.
Compatibility
All p48 MW (HPC) models are compatible with the TrevoPro18 microcatheter from Stryker
Neurovascular, USA, which has an internal diameter of 0.021 inches (0.53 mm).
In its relaxed state, the diameter of the p48 MW (HPC) is approx. 0.8 mm larger than the nomi-
nal diameter. The length specifications on the packaging describe the clinically usable length.
The p48 MW (HPC) must be used according to the specifications regarding the minimum and
maximum target vessel diameters which are stated on the packaging.
p48 MW (HPC) is available in the following versions:
- Uncoated:
- Coated with HPC:
The size specifications are indicated by the REF no., and are also stated on the packaging.
P48 - MW - HPC - X00 - XX
HPC: Coated with HPC
No "HPC": Without coating
Recommended procedure
1. Gather and document as complete a case history as possible, especially regarding the
history of the present illness, comorbidities, previous interventions and current medication.
2. As far as possible, inform the patient and document the patient's consent to the planned
intervention, pointing out the possible complications and potential consequences (disability,
care dependency or death). In cases where patients cannot give consent themselves, their
relatives should, as far as possible, be asked if they know what the presumed patient's will
would be. Otherwise, in case of emergency, the rules of emergency care for incapacitated
patients apply, subject to different institutional or national requirements.
3. Promptly take all measures necessary for suitable pretreatment with drugs to ensure the
inhibition of platelet aggregation. Based on current knowledge, dual antiplatelet therapy
when implanting the p48 MW (HPC) and similar products is suitable for the prevention of
thrombus formation caused by the implant. For this purpose, 100 mg of ASA and 75 mg
of clopidogrel can be administered orally every day for at least 3 days before the planned
intervention. Alternatively, 500 mg of ASA and 600 mg of clopidogrel can be administered
orally as one-off doses on the day before treatment.
In vitro test results and initial clinical experience demonstrate that the version p48 MW HPC
can provide a reduced surface thrombogenecity. 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.
The safety of the treatment is increased if the effective inhibition of platelet function is
verified by means of an appropriate test (e.g. Multiplate, VerifyNow, PFA) before the

can be
intervention. Regarding substitutes in case of resistance to clopidogrel and the use of Gp
IIb/IIIa antagonists, we refer you to the respective current specialist literature.
4. A CT or MRI examination of the cranium and, where necessary, the throat is advisable
beforehand, in order to ensure a comprehensive preliminary diagnosis.
5. The diagnostic angiography and endovascular treatment should be carried out under
general anesthesia with neuromuscular relaxation and invasive hemodynamic monitoring.
can be moved
During anesthesia, aim to maintain suitable systolic blood pressure values.
6. After preparing both groins, a 6F or 8F catheter is inserted, preferably into the right femoral
artery.
7. Then moderate heparinization should begin, which should also last for the duration of the
intervention. An intravenous dose of between 3000 and 5000 units of heparin has proven
suitable in practice. Where available, determining the ACT ("activated clotting time") is
advisable.
8. Angiographic visualization of the internal and external carotid arteries on both sides and
of the vertebral artery on at least one side is recommended, along with the respective
dependent vessels. Enlarged images and, where necessary, oblique images of the affected
vessel(s) are recommended.
9. The target vessel(s) for the endovascular treatment must be defined.
10. A 6F guide catheter or the combination of an 8F guide catheter and a suitable extension
catheter is inserted into the afferent cervical vessel, taking steps to avoid vasospasm.
11. Measure the diameter of the target vessel, where the distal and proximal ends of the
p48 MW (HPC) are to be anchored, as accurately as possible.
It is important that the implant is only inserted into target vessels of suitable size. Carefully
observe and respect the specifications regarding the minimum and maximum vessel
diameters on the packaging, as well as the instructions regarding selection of a model of
p48 MW (REF no. P48-MW-XXX-XX)
p48 MW HPC (REF no. P48-MW-HPC-XXX-XX)
implant length (mm) in max. vessel Ø
max. vessel Ø (mm)