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[PRODUCT DESCRIPTION]
Metacross OTW is a Percutaneous Transluminal Angioplasty (PTA)
Balloon Dilatation Catheter for peripheral indications. Metacross
OTW is an over the wire (OTW) type and the maximum diameter of
the compatible guidewire is 0.035 inches (0.89 mm).
The distal section of this catheter consists of a balloon and dual
lumen shafts (co-axial). The outer lumen is used for inflation and
deflation of the balloon with contrast medium diluted with saline
solution. The inner lumen (the guidewire lumen; from the distal tip to
the guidewire port) is for inserting a compatible guidewire to
facilitate advancing the catheter through the stenotic lesion or stent
to be dilated. The proximal section is a double lumen shaft with dual
luer port Manifold; one for inflation/deflation of the balloon, the other
for guidewire lumen access. Inside the balloon, two radiopaque
markers, which indicate the working length of the balloon, are
placed to guide the physician for positioning the balloon properly in
the targeted lesion under fluoroscopy. Metacross OTW is available
in various balloon sizes by its diameter and length at recommended
inflation pressures (Nominal pressure). Upon inflation, the balloon
diameter varies according to the inflating pressure. The balloon
compliance chart of Metacross OTW is provided in Table 1 at the
end of this Instructions for Use. In the sterilization package, the
device is equipped with the protective materials, a balloon protective
tube and a stylet, which are to be removed before use. The balloon
protective tube is placed over the balloon folded in a low profile and
the stylet is inserted into the guidewire lumen to prevent collapsing
the catheter shaft. The catheter’s distal tip is tapered to facilitate the
catheter’s advancing into the stenotic lesion or stent.
<NAME OF EACH PART>
Sterile and non pyrogenic in an undamaged and unopened blister
pouch. This device is sterilized by ethylene oxide.
Recommended guidewire diameter:
Maximum diameter: 0.035”(0.89 mm)
Recommended inflation pressure and maximum inflation pressure
Nominal pressure:
- Balloon diameter: smaller than 6 mm: 10atm
- Balloon diameter: 6 mm and larger:
8atm
Rated burst pressure:
- Balloon diameter: smaller than 5 mm: 20atm
- Balloon diameter: 5 mm :
18atm
- Balloon diameter: 6mm, 7mm, 8mm :
14atm
- Balloon diameter: 9 mm and larger:
12atm
[INDICATIONS]
The Metacross OTW PTA balloon dilatation catheter is intended to
dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-
popliteal and renal arteries, and for the treatment of obstructive
lesions of native or synthetic arteriovenous dialysis fistulae. This
device is also indicated for stent post-dilatation in the peripheral
vasculature.
Note: The verification test for stent post-dilatation of Metacross
OTW was conducted using Complete
®
SE Vascular Stent System
(Medtronic, Inc), S.M.A.R.T.
®
CONTROL
®
Vascular Stent System
(Cordis Corporation) and Epic
TM
Vascular Self-Expanding Stent
System (Boston Scientific Corporation).
[CONTRA-INDICATIONS]
1. Patients who have developed anastomotic stenosis within one
month after AV shunt construction.
2. Patients having lesions which communicate with a
pseudoaneurysm.
3. Patients who are pregnant.
4. Patients who cannot tolerate antiplatelet therapy or anticoagulant
therapy.
[WARNINGS AND PRECAUTIONS]
[Warnings]
1. This device is for single use only. Do not reuse. Do not resterilize.
Do not reprocess. Reprocessing may compromise the sterility, the
biocompatibility and the physical integrity of the device.
2. Do not use if the product or the unit packaging has been damaged.
3. Do not inflate the balloon exceeding the diameter of the blood
vessel proximal and distal to the stenotic lesion.
4. Do not inflate the balloon to a pressure exceeding the rated burst
pressure.
5. Do not use this catheter in the central circulatory system.
[Precautions related to procedures]
1. Do it carefully and slowly to remove this device out of the carrier
tube and to remove protection parts from this device, Careless
handling may damage the balloon and/or the catheter shaft of
this device to
impair balloon inflation and/or deflation.
2. Inflate the balloon with the contrast medium diluted with saline in
the ratio of 1:1 (hereafter, inflation fluid). No gaseous medium
such as air should be used for inflation. (Balloon may be inflated
irregularly.)
3. Prior to use, expel all the air in the balloon and balloon inflation
lumen and replace it with the inflation fluid. (In case of incomplete
air removal, balloon inflation state can not be observed under
fluoroscopy.)
4. In case of serious stenotic lesions such as calcified lesions, the
blood vessel can not be dilated fully. Do not apply a pressure
exceeding the rated burst pressure in such a case. (The balloon
may burst and the debris may remain inside the body.)
5. As for the medical devices used in conjunction with this catheter,
follow the instructions for use of such devices. (When the balloon
catheter is used for post-dilatation of stent during peripheral stent
placement procedure, refer to the manufacturer’s instructions for
use.)
6. For insertion into stent, withdrawal from stent or in-stent dilatation of the
balloon, proceed with caution under fluoroscopy. (Doing so without
fluoroscopy may damage this catheter or injure the blood vessel.)
7. Do not attempt to pass the Metacross OTW PTA balloon dilatation
catheter through a smaller sized introducer sheath than indicated
on the label. Refer to product labeling.
[Precautions during usage]
1. Use the device immediately after the sterile package is opened.
2. The entire procedure should be carried out aseptically.
3. This catheter should be used only by physicians skilled in
percutaneous vascular therapy.
4. Select the catheter with appropriate balloon size (balloon
diameter, balloon length) according to the following (procedures)
criteria.
1) The inflated balloon diameter shall not exceed the inner
vessel diameter proximal and distal to the lesion.
2) The length of the inflated balloon shall not exceed the
length of the lesion to be treated.
ENGLISH