INDICATIONS
The Crosstella RX PTA balloon dilatation catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal 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 Crosstella RX was conducted using Complete® SE Vascular Stent System (Medtronic, Inc), S.M.A.R.T.® CONTROL® Vascular Stent System (Cordis 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
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 Crosstella RX PTA balloon dilatation catheter through a smaller sized introducer sheath than indicated on the label. Refer to product labeling.
