English - InspireMD MGUARD Prime Instrucciones De Uso

Instructions for Use - English
1. Description
MGuard Prime coronary Stent System is a coronary balloon
expandable stent, wrapped with a fiber sleeve, and premounted
on an expandable balloon catheter/Stent Delivery system (SDS).
MGuard Prime stent platform is a laser cut cobalt chromium alloy
(CoCr) bare stent. It is constructed of circumferential strut rings
that are connected to each other with flexible links.
The MGuard Prime sleeve is knitted from a Polyethylene
Terephthalate (PET) microfiber that creates a flexible mesh with
low coverage area and cells diameter of 180 micron.
The SDS/ Catheter is a double lumen catheter for rapid exchange
(RX) use with a semi-compliant balloon and two radiopaque
markers, proximal and distal, to aid the balloon positioning under
fluoroscopy. There is a proximal end Luer lock connector (hub) for
balloon inflation.
MGuard Prime is supplied in specific diameter and length (see
chart and labeling). Nominal stent length and diameter are also
printed on the catheter hub.
2. Indications
MGuard Prime Coronary Stent System is indicated for improving
luminal diameter in vessels with reference diameter from 2.5 to 4.0
mm having lesion length <38 mm and providing embolic protection
in the following cases:
Symptomatic coronary artery disease due to discrete de novo
•
or restenotic lesion in native coronary artery.
Symptomatic coronary artery disease due to culprit lesion in
•
saphenous vein graft.
Treatment of coronary lesion in patients undergoing primary
•
or rescue PCI for acute ST-segment elevation myocardial
infarction(STEMI).
MGuard Prime chart
Stent Diameter Stent Lengths
(mm) Avaliable (mm)
2.5 8,13,18,23,28,33,38
2.75 8,13,18,23,28,33,38
3.0 8,13,18,23,28,33,38
3.25 8,13,18,23,28,33,38
3.5 8,13,18,23,28,33
3.5 38
4.0 8,13,18,23,28
4.0 33,38
2

English

Minimum Guiding Maximum guide wire
catheter compatibility compatibility
6F (1,78mm) 0,014"(0,36mm)
6F (1,78mm) 0,014"(0,36mm)
6F (1,78mm) 0,014"(0,36mm)
6F (1,78mm) 0,014"(0,36mm)
6F (1,78mm) 0,014"(0,36mm)
6F (1,78mm) 0,014"(0,36mm)
6F (1,78mm) 0,014"(0,36mm)
6F (1,78mm) 0,014"(0,36mm)
Treatment of coronary lesion having atherothrombotic
•
appearance in patients with non ST-elevation acute coronary
syndromes (unstable angina and non ST-segment elevation
myocardial infarction).
3. Contraindications
General contraindications for coronary stenting and for the use of
this device are:
Unprotected left main coronary artery disease;
•
Bifurcation coronary stenosis;
•
Any patients judged to have a lesion which may prevent
•
proper stent deployment;
Contraindication for anti-platelets and/or anti-coagulation
•
therapy;
Known allergies to contrast media, Co-Cr or Polyethylene •
Terephthalate.
4. Warnings
PTCA and coronary stent implantation are recommended
•
only at hospitals where emergency coronary artery bypass
graft surgery can be immediately performed in the event of
a potential injury or life-threatening complication. A surgical
team should be on standby when an interventional procedure
is being performed.
Only physicians thoroughly trained and educated in the
•
performance of percutaneous trans luminal coronary angioplasty
(PTCA) and coronary stenting should use this device.
Cautious selection of patients is necessary since the use of
•
this device carries the associated risk of sub-acute thrombosis,
vascular complications and/or bleeding events.
This device is designed and intended for single use only.
•
Stent deployment
pressure (atm)
8
8
8
8
8
8
8
8
Rated burst Strut thickness
pressure (atm) (micron)
16 80
16 80
16 80
16 80
16 80
14 80
16 80
14 80
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PAC-0318-V4