Highlights of the METACROSS RX PTA Dilatation Balloon Catheter include:

• First ever 0.035” PTA rapid exchange balloon catheter for peripheral use
• Best-in-class pushability using an innovative catheter design1
• Excellent crossability with smallest balloon profile1
• Category-leading deflation time1

INDICATIONS

The Metacross 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.

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.

・Local or systemic infections ・Local internal bleeding or hematoma ・Intimal rupture ・Vascular dissection ・Vascular perforation ・Vascular rupture ・Aneurysm ・Arrhythmia ・Acute vascular occlusion ・Venous thromboembolism ・Vasospasm ・Formation of pseudoaneurysm ・Arteriovenous fistula ・Bleeding requiring transfusion ・Allergic response to the contrast media / renal failure ・Ache or pressing pain ・Death ・Embolism ・Endocarditis ・Fever ・Hypertension / Hypotension ・Inflammation ・Myocardial Infarction ・Sepsis ・Shock