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For dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The 7.0/8.0mm x 40mm AngioSculpt PTA Scoring Balloon Catheters are comprised of a conventional balloon catheter that incorporates a nitinol scoring element over the balloon. The balloon is designed to expand to a specified diameter at a specified pressure. The catheter has radiopaque markers to aid in positioning of the balloon in the stenosis. The catheter has two lumens; one lumen is used for inflation of the balloon with contrast medium; the other lumen permits the use of a quide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The product is provided in the over-the-wire (OTW) delivery platform. The catheters have a sheath compatibility of 6F and guidewire compatibility of 0.018". The catheter is single-use only and provided sterile to the user.