Sterling® ES Balloon Dilatation Catheters

Prescriptive Information

Prior to use please see the complete 'Directions for Use' for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator's Instructions.

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Indications for Use

The Sterling ES PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The 2.0mm - 4.0mm balloon devices are also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

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Contraindications

None known.

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Precautions

The Sterling ES OTW and Monorail Balloon Dilatation Catheter shall only be used by physicians trained in the performance of percutaneous transluminal angioplasty.

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Cautions

Short-term and long-term biological effects at pressures above the nominal pressure are not known.

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Adverse Effects

The complications that may result from a balloon dilatation procedure include, but are not limited to: Abrupt closure • Allergic reaction (device, contrast medium and medications) closure • Amputation closure • Aaneurysm closure • Angina closure • Arrhythmias, including ventricular fibrillation closure • Arteriovenous fistula closure • Coma closure • Death closure • Deep vein thrombosis closure • Embolization air, device, plaque, etc. closure • Hematoma closure • Hemorrhage, including bleeding at puncture site, hypotension/hypertension closure • Infection closure , local or systemic closure • Ischemia, including tissue ischemia, steal syndrome and necrosis closure • Myocardial ischemia or infarction closure • Need for additional intervention or surgery closure • Neuropathies or nerve injury closure • Organ failure (single, multiple) closure • Pulmonary embolus closure • Pain closure • Pseudoaneurysm closure • Renal closure • Restenosis closure • Shock closure • Stroke closure • Vessel injury, e.g. dissection, perforation, other claudication closure • Vessel occlusion closure • Vessel spasm closure • closure • Vessel thrombosis closure • Weakness

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