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FDA Approves Lutonix Drug-Coated Balloon

Posted on : 12 October 2014
MedPage Today reports that the device\'s balloon is coated with paclitaxel and for use in native femoropopliteal arteries to prevent restenosis after angioplasty. Approval was based primarily on the the prospective, single-blinded, randomized multisite LEVANT-2 study, which compared the safety and effectiveness of the drug-coated balloon with a standard balloon. Findings were presented at the FDA panel meeting in June. Read more

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