Lutonix has developed a balloon catheter that is very similar in shape and size to other small balloon catheters except that the balloon is coated with a drug called paclitaxel. The Lutonix Drug Coated Balloon Catheter is an investigational device and is not approved for commercial use in the US. The purpose of this research study is to investigate if the treatment of narrowed leg blood vessels below the knee with the Lutonix Drug Coated Balloon Catheter is safe and beneficial.
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