phenox p64 MW Instrucciones De Uso página 5

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 content
1 x p64 MW (HPC) Flow Modulation Device (of version p64 MW or p64 MW HPC)
Product description
Fig. 1: p64 MW (HPC) implant and delivery system in introducer sheath
Fig. 2: Delivery system and detached p64 MW (HPC) implant
Please note that in the following text the term p64 MW (HPC) stands for both device versions, p64 MW
(uncoated) and p64 MW HPC (coated).
The p64 MW (HPC) Flow Modulation Device is a tubular vascular implant that consists of 64 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 p64 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  at the distal end of the transport tube  and another one
at the distal wire tip  to allow the operator to determine its position.
The attachment of the implant  to the delivery system  follows the friction locking principle: The proximal end
of the implant
 is secured between a soft polymer pad (at distal end of the transport tube  ) and an introducer sheath 
(after removal of the sheath, the function is performed by the microcatheter), in such a way that pushing and
pulling of the implant  is enabled.
The product is stored in an introducer sheath  and is transferred into a microcatheter with an inside diameter
of 0.021 inches (0.53 mm). This sheath  is moved proximally during insertion of p64 MW (HPC) to enable
complete passage through the microcatheter.
A white Flourosafe Marker  on the transport tube  identifies the position to which the device can be
advanced inside the microcatheter without the device tip leaving 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  at the distal end of the transport tube  : As long as the marker  is located inside the
microcatheter the implant  can be completely recovered.
The p64 MW (HPC) is always deployed by means of a coordinated movement, whereby the microcatheter
is withdrawn and the delivery system  is advanced to avoid any movement of 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  can be moved proximally after the torquer  is released
prior to the implant  being 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 (0.36 or 0.41 mm)
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.
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  is completely deployed and detached from the delivery system  by withdrawal of the
microcatheter.
Intended use
The p64 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 p64 MW (HPC) straighten the target vessel slightly and reinforce it.
These properties aid the endovascular reconstruction of diseased arteries along their cervical and
intracranial course.
Indications
The p64 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 p64 MW (HPC) models are compatible with the Rebar-18 microcatheter (Medtronic, USA) which has an
inner diameter of 0.021 inches (0.53 mm).
In its relaxed state, the diameter of the p64 MW (HPC) is 0.4 mm larger than the nominal diameter. The
length specifications on the packaging describe the clinically usable length.
The p64 MW (HPC) must be used according to the specifications regarding the minimum and maximum
target vessel diameters which are stated on the packaging.
p64 MW (HPC) is available in the following versions:
- Uncoated: p64 MW
- Coated with HPC: p64 MW HPC
The size specifications are indicated by the REF no., and are also stated on the packaging:
P64 - MW - HPC - XX0 - XX
implant length in mm in max. vessel Ø
max. vessel Ø in X.X mm
HPC: Coated with HPC
No "HPC": Without coating
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 p64 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 p64 MW (HPC) with a range of application below the diameter of
the target vessel) leads to insufficient fixation of the p64 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 p64 MW (HPC).
Information on the selection of patients and lesions
If compliance to the antiplatelet medication cannot be guaranteed following the implantation of a p64 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 p64 MW (HPC).
From the time of implantation of a p64 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.
Medication
Prior and following implantation of a p64 MW (HPC) antiplatelet medication is necessary as described in
the chapter "Recommended procedure". Be mindful of possible interactions with other medications (e.g. with
proton pump inhibitors, Ibuprofen, Metamizole).
In vitro test results and anectdotal clinical experience demonstrate that the version p64 MW HPC can
provide a reduced surface thrombogenecity. In justified exceptional cases the reduced thrombogenecity can
allow the implantation under single antiplatelet medication, only if there no reasonable alternative therapy
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).
Single antiplatelet medication may have an increased risk of thromboembolic events if multiple devices
have been implanted in a telescoping fashion. The risk of thrombus formation may be increased after
subarachnoid hemorrhage, after trauma, during pregnancy, after major surgery, during inflammatory
diseases, fever, thrombocytosis.
In general dual antiplatelet medication in the context of flow diverter implantation is safer than mono
medication concerning the risk of thromboembolic events. Dual antiplatelet medication, however, carries
a higher risk of hemorrhagic events.
ASA is less efficacious than P2Y12 inhibitors concerning the protection from thromboembolic events.
Several conditions increase the required ASA dosage significantly (intracranial hemorrhage, pregnancy,
trauma, surgery, thrombocytosis, fever, pneumonia...). The action of ASA is antagonized by Ibuprofen and
Metamizole. ASA is in several countries available as a variant which can be given IV. ASA does usually not
cause hemorrhagic issues if surgery is required.
Prasugrel has been reported to prevent thrombus formation on HPC coated devices. These are so far
anecdotal observations. Controlled trials are pending. The risk of hemorrhagic complications from Prasugrel
remains a concern.
Ticagrelor might be a compromise for single antiplatelet medication. The short-acting time requires
consistent intake.
Recommended procedure
Preparation of procedure and patient,
platelet aggregation inhibition and patient testing
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
(REF no. P64-MW-XXX-XX)
(REF no. P64-MW-HPC-XXX-XX)
B871B p64 MW IFU / 2019-12-17 5