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<h2>Indications, Safety, and Warnings</h2> Note: Safety information provided is for the United States. Please refer to your region’s instructions for use for specific details. This therapy is not for everyone. Please consult your physician. A prescription is required. Prior to use, refer to the instructions for use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings, and precautions. <h3>Reference statement</h3> Indications for Use: The NanoCross™ Elite PTA Catheter is indicated to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, and infrapopliteal arteries. Contraindications: The NanoCross™ Elite PTA Catheter is contraindicated for use in the coronary arteries or in the neurovasculature, or when unable to cross the target lesion with a guidewire. Potential Adverse Events: The potential adverse events (or complications) that may occur or require intervention with the use of this device include, but are not limited to, the following conditions: Allergic reaction; Aneurysm; Arrhythmia; Bleeding requiring transfusion; Contrast medium reaction or renal failure; Death; Embolism; Endocarditis; Fever; Hematoma; Hemorrhage; Hypertension or hypotension; Infection; Inflammation; Intraluminal thrombus; Myocardial infarction; Pseudoaneurysm; Regional ischemia; Sepsis; Shock; Stenosis or restenosis; Stroke; Transient ischemic attack; Venous thromboembolism; Vessel injury (such as dissection, perforation, or rupture); Vessel spasm. If a serious incident related to the device occurs, immediately report the incident to Medtronic and the applicable competent authority or regulatory body. Important: Please reference the Instructions for Use (IFU) or Electronic Instructions for Use (eIFU) at <a href="https://manuals.medtronic.com/manuals/" target="_blank">https://manuals.medtronic.com/manuals/</a> for a complete listing of indications, contraindications, warnings and precautions, adverse effects, and suggested procedure. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. FTSOP113326-58c

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