Contraindications - phenox pCANVAS 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 pCANVAS Bifurcation Aneurysm Flow Modulating Implant
Product Description
Shaft
Fig. 1: pCANVAS implant (lateral view and view from the distal end)
Insertion system
Fig. 2: pCANVAS complete system
The pCANVAS Bifurcation Aneurysm Flow Modulating Implant is a tubular vascular implant and
consists of a shaft and a crown, which spans a microporous membrane (Fig. 1).
In its design features, the shaft corresponds to a self-expanding microstent for intracranial
vessels. It is used to anchor the implant in the parent vessel, in the bifurcation of which the
aneurysm to be treated is located. A platinum marker
The distal end of the implant features four petal-like loops
like contact surface (crown), which spans a microporous membrane. These petals fold together
when the pCANVAS is in a compressed state. After the pCANVAS is released in the aneurysm,
these petals unfold radially outwards. In doing so, the axis of the petal assumes an angle of up
to 75° in relation to the longitudinal axis of the shaft. Two of the petals each bear a radiopaque
marker ranging from the distal petal end to the membrane plane in the stent shaft cross-section.
The other two petals each bear a radiopaque marker
membrane plane. On implants with a crown diameter of 5 or 6 mm all four markers span from the
distal petal end to the membrane plane in the stent shaft cross-section.
The proximal end of the implant is connected to an insertion wire
bridge (Fig. 2). This connection can be separated electrolytically. To enable alignment of this
detachment point distal to the tip of the microcatheter, a 30 mm-long radiopaque marker
located proximal to the detachment point.
An introducer sheath (not shown) is placed on the insertion system in which the implant is inserted
and from which it is subsequently transferred into a microcatheter with an inside diameter of
0.027 inches. The introducer sheath exhibits a ring marker for positioning and a fl ushing cavity. After
the insertion of the pCANVAS into the microcatheter, the introducer sheath is withdrawn proximally.
Once the implant leaves the microcatheter, it deploys by itself. When used as intended, the
crown is released in the aneurysm and the shaft in the parent vessel. Even after it is fully
released in the aneurysm and target vessel, the implant can be completely withdrawn into the
microcatheter again to allow its position to be corrected or allow its removal.
The pCANVAS is always released by slowly withdrawing the microcatheter whilst advancing the
insertion wire to allow it to maintain its position unchanged. Correspondingly, if the pCANVAS
is withdrawn into the microcatheter, this always occurs by means of a coordinated movement,
whereby the microcatheter is advanced and the insertion wire is withdrawn.
All manipulations are always carried out under fl uoroscopic visualization.
After a fi nal check of the opening and the position, the implant is electrolytically detached.
This detachment corresponds to that of electrolytically detachable platinum microcoils and
may be carried out using the conventional detachment devices and detachment cables for
that procedure (e.g. NXT Detachment System, ev3/Covidien/Medtronic, or Boston Scientifi c
Detachable Coil Power Supply, Boston Scientifi c/Stryker Neurovascular).
Intended Use
The pCANVAS Bifurcation Aneurysm Flow Modulating Implant is a self-expanding, tubular
vascular implant with a fl ow modulating eff ect for the treatment of wide-neck intracranial
bifurcation aneurysms. It still allows an additional subsequent coil occlusion.
Explanatory notes regarding the intended use:
The crown of the pCANVAS spanning a microporous membrane is implanted in the aneurysm,
near to the base. This defi nes a boundary between aneurysm and parent vessel in the case
of aneurysms with a wide transition from a vascular bifurcation to the aneurysm fundus. The
membrane defi ning this boundary causes a fl ow modulating eff ect. The shaft, which is released
in the parent vessel, stabilizes the crown in this position. In addition, the physical properties of
the pCANVAS straighten the target vessel slightly and strengthen it. The design features of the
Crown
Crown
pCANVAS implant
is located at the tapered proximal end.
, which together form a crown-
of approx. 1 mm in length at the
via a cobalt-chromium
is
pCANVAS do not have a hemodynamic eff ect on the arteries which originate in the vicinity of the
aneurysm and which are overlapped by the distal part of the shaft. If necessary, the implantation
of a pCANVAS in an aneurysm and parent vessel can be combined with the implantation of a
self-expanding stent in one of the side branches.
Indications
The pCANVAS Bifurcation Aneurysm Flow Modulating Implant is used to treat wide-necked
bifurcation aneurysms in intracranial arteries by spanning a fl ow diverting microporous
membrane within the aneurysm neck and by allowing additional coil insertion. The microporous
membrane promotes the formation of a new inner vessel wall (neointima). Typical locations for
such aneurysms are the bifurcation of the internal carotid artery, the anterior communicating
artery, the middle cerebral artery and the bifurcation of the basilar artery. However, in principle,
every wide-necked aneurysm in the bifurcation of a vessel can be suitable.
Depending on the clinical circumstances and the vascular anatomy, both unruptured and
ruptured aneurysms can be treated with this implant. When treating ruptured aneurysms, one
must decide carefully to what extent it is possible to use antiplatelet medication.

Contraindications

The treatment is contraindicated for use in patients for whom:
• Antiplatelet and/or anticoagulation therapy is contraindicated
• Antiplatelet therapy did not start in a timely manner prior to treatment
• Antiplatelet and/or anticoagulation therapy (with e.g. acetylsalicylic acid, Clopidogrel,
Prasugrel or Ticagrelor) was ineff ective
• Angiography demonstrates the anatomy is not appropriate for endovascular treatment.
Compatibility, Versions
All pCANVAS models are designed for microcatheters which have an inside diameter of
0.027 inches (0.69 mm). The following microcatheters are recommended:
• Excelsior XT-27 (Boston Scientifi c/Stryker Neurovascular)
• ReVerse 27 (Reverse Medical/Covidien/Medronic)
• Rebar 027 (ev3/Covidien/Medtronic)
In order to prevent the distal ends of the petals directly striking the wall of the aneurysm being
treated when the pCANVAS is inserted, it may be helpful to use a microcatheter with a curved tip
or to shape the chosen microcatheter yourself over steam or heated air.
The pCANVAS must only be used in compliance with the specifi ed minimum and maximum
target vessel diameters, as stated on the packaging.
The size specifi cations are indicated by the REF no., and are also stated on the packaging.
pCAN- X- XX- XX
Crown diameter (mm) when fully expanded
Shaft length (mm) when fully expanded
Shaft diameter (mm) when fully expanded
The shaft of the stent becomes shorter as it progressively expands radially from its compressed
state (in the microcatheter) to its maximum diameter.
Recommended Procedure
The following recommendations conform to the established clinical practices for endovascular
treatment of intracranial aneurysms. Insofar as there are already clinical experiences with the
pCANVAS these have been taken into account. phenox GmbH strives to collect and evaluate
data from the clinical application of the pCANVAS, and the results are promptly added to the
recommendations for use. All users certifi ed by phenox GmbH are informed personally in writing
about any changes and additions to the re-commendations for use (update letter in English).
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
according to standard of care.
2. As far as possible, inform the patient and document the patient's consent according
to standard of care to go ahead with the planned intervention, pointing out the possible
complications and potential consequences (disability, care dependency, death).
3. Take all measures in a timely manner which are necessary for suitable pretreatment with
drugs to ensure the inhibition of platelet aggregation. Based on current (2017) knowledge,
dual antiplatelet therapy when implanting the pCANVAS 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. The safety of the
treatment is presumably increased if the eff ective inhibition of platelet function is verifi ed
by means of an appropriate test (e.g. Multiplate®, VerifyNow®) before the intervention.
Regarding substitutes in case of resistance to clopidogrel and the use of GP IIb/IIIa
inhibitors, 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.
During anesthesia, aim to maintain suitable systolic blood pressure values.
6. After preparing both groins (shaving, disinfection), 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.
B835B pCANVAS IFU / 2017-01-23
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