Tabla De Contenido - phenox pRESET Instrucciones De Uso

ENGLISH
INSTRUCTIONS FOR USE
pRE / pRE LT
® ®
SET SET
Manufacturer
phenox GmbH
Lise-Meitner-Allee 31
44801 Bochum, Germany
Phone: +49 234 36 919 0
Fax: +49 234 36 919 19
Content
1 x pRESET (LT) Thrombectomy Instrument (pRESET / pRESET LT)
Device Description
The pRESET (LT) consists of a self-expanding Nitinol structure , carries one
x-ray visible marker on its proximal  and two on its distal end  and is firmly
attached to an insertion wire . The device is stored in compressed form in an
introducer sheath (not displayed).
The pRESET (LT) is introduced into the target vessel through a suitable micro-
catheter and deployed inside the thrombus or distal to the thrombus. After com-
plete deployment the slow withdrawal of the instrument occurs under continuous
aspiration via the guiding catheter or aspiration catheter.
MARKER
 
pRESET LT
MARKER
 
Indications for Use
The pRESET (LT) Thrombectomy Stent is designed for mechanical clot retrieval
from intracranial arteries as acute ischemic stroke treatment
▪ for patients who are ineligible for intravenous thrombolysis or
▪ for patients who failed thrombolysis therapy and
▪ as a supplement treatment of an initiated thrombolysis therapy.
Contraindications
The pRESET (LT) device is contraindicated in patients with
▪ preexisting hemorrhage in the brain tissue supplied by the target vessel and
▪ established infarction in the brain tissue supplied by the target vessel
Compatibility
The following pRESET (LT) device and catheters are compatible and are recom-
mended for use in minimum vessel diameters:
pRE (LT) Insertion
SET
Wire
Device
Length
PRE-LT-3-20 1,8 m
ID 0.017'':
- ECHELON 10 / 14
PRE-LT-4-20 1,8 m
- EXCELSIOR SL 10
- HEADWAY 17
PRE-4-20 1.8 m ID 0.021'':
- TREVO PRO 18
- PROWLER Select Plus
- VELOCITY
- REBAR 18
PRE-6-30 1.8 m
ID 0.021'':
- TREVO PRO 18
- PROWLER Select Plus
- VELOCITY
Recommended Procedure
1. Record and document any available information about the date, time and
nature of the onset of clinical stroke symptoms.
2. Record and document data on past and recent medical history, including
medication.
3. Inform and document consent of the patient and available relatives. Explain
potential risks and benefits to the patient and/or his/her relatives. Potential
risks include failure of treatment, transient or permanent neurological and/or
physical morbidity or death as a result of disease or treatment. Refer to the
relatives for the patient's presumed decision. In case neither patient nor rela-
tives can contribute to decision-making, apply the valid rules for emergency
medical treatment of patients with legal incapacity.
4. A native CT scan of the brain is required to rule out intracranial hemorrhage


pRESET
Microcatheter Min.
vessel Ø
1,5 mm 3 x 20 mm
1,5 mm 4 x 20 mm
2 mm 4 x 20 mm
3 mm 6 x 30 mm
or large hypodense ischemic brain lesions. In that case the use of the pRE-
SET (LT) is contraindicated.
5. Induce general anesthesia with neuromuscular relaxation from the very be-
ginning of the angiographic diagnosis and eventual endovascular treatment.
Complete hemodynamic monitoring is recommended, but must not delay the
endovascular procedure. Advise the anesthesiologist to maintain appropriate
levels of systemic blood pressure. Hypotension is to be strictly avoided.
6. Prepare both groins, introduce 8F sheath in the right femoral artery.
7. For vessel diagnostic conduct angiography of the complete anterior and
posterior circulation including phlebograms. Take magnified views of the
occluded vessel(s), and if necessary oblique views.
8. Define the occluded vessel(-s) as target(-s) for further therapy.
9. Use the largest possible guiding catheter (VA: 6F, ICA: 8F). In the case of
significant elongation or stenosis of the access vessel, consider the implan-
tation of a suitable stent. In the case of stenting the administration of suitable
inhibitors of platelet aggregation is to be followed. According to user reports,
an 8F guiding catheter with balloon occlusion and a flexible 5 to 6F extension
or aspiration catheter to get closer to the thrombus site for aspiration can be
useful for thrombectomy.

10. It is important that the device is introduced in sufficiently large target vessels
only. Heed the minimum vessel diameter and the catheter compatibility.
11. Introduce a suitable microcatheter (see table above) into the target vessel,
with careful passage beyond the thrombus. The application of the so-called
"road map" technique is recommended. Never catheterize against any

resistance!
12. Withdraw the microguidewire from microcatheter. The careful injection of a
small amount (0.2 ml) of contrast medium may be used to verify the proper
position of the tip of the microcatheter beyond the thrombus and in the vessel
lumen.
13. With a rotating hemostatic valve (RHV) and slow but constant saline flushing
connected to the microcatheter, the pRESET (LT) will be introduced into
the microcatheter. During this process, the RHV will be opened, the tube
(introducer sheath) with the device inside will pass the valve, the valve will
gently be closed and the tube will be flushed back until water exits from the
proximal end of the tube.
After the tube with the device inside is flushed, the tube will be advanced
until close contact with the hub of the microcatheter. The tube will be firmly
kept in this position; the pRESET (LT) is advanced from the tube into the
microcatheter by gentle pushing of the insertion wire. The process of device
advancement will be continued until about sixty (60) cm of the insertion wire
are pushed forward. The tube will be removed.
The pRESET (LT) is pushed further forward until the marker ("MARKER":
distance to distal device tip approx. 125 cm in compressed condition) of the
insertion wire reaches the entry of the hemostatic valve. This procedure does
not need fluoroscopy because the marker ("MARKER") identifies the position
Relaxed Ø
to which the system can be advanced without the device tip leaving the
x Usable
microcatheter.
Length
The process of pRESET (LT) insertion is more or less the same as using an
electrolytically detachable coil. The observed friction will be slightly stronger
than using a regular coil. In case of major resistance remove the device and
eventually the microcatheter and start from the beginning.
14. Under continuous fluoroscopy the device will be ad vanced until the tip of the
microcatheter will be reached by the distal marker of the device.
Never push the pRESET (LT) beyond the distal tip of the microcatheter! To
do so may result in dissection or perforation of the concerning artery.
15. Deploy the device completely by gentle and slow withdrawal of the micro-
catheter until the microcatheter tip is located sufficiently proximal. This is
achieved if the distal microcatheter marker is placed proximal to the proximal
x-ray visible pRESET (LT) marker. During this process, use continuous fluo-
roscopy to keep the pRESET in its original position. The instrument is ideally
deployed in the thrombus. Is the pRESET (LT) longer than
the thrombus, the instrument should protrude distally.
The illustration right hand depicts the radiographic image
of a pRESET (LT).
16. Wait 5 (five) minutes before starting the withdrawal. The saline flush will be
removed from the guiding catheter RHV and will be replaced by a fifty (50) ml
syringe with Luer Lock. Two (2) additional syringes of the same size will be
prepared and available. Take care for firmly closed valves to avoid aspiration
of air.
17. If applicable, inflate the balloon of the guide catheter acc. to its IFU.
18. During continuous aspiration on the guiding catheter, the unit microcathe-
B 824 G pRE
B 824 G pRE
IFU / 2016-05-04
SET
IFU / 2016-05-04
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