AB35W05060080

Indications, Safety, and WarningsNote: 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.Reference statementIndications for use: The EverCross PTA Catheter is indicated to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, and infrapopliteal arteries, and for the treatment of obstructive lesions of native arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral arteries.Contraindications: The EverCross 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; Arteriovenous fistula; 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 https://manuals.medtronic.com/manuals/ for a complete listing of indications, contraindications, warnings and precautions, adverse effects, and suggested procedure.Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.FTSOP113326-53c

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