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Drug Eluting Balloons
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.
Renowned medical devices maker CR Bard (BCR) has enrolled the first patient for its revolutionary Lutonix Below the Knee (:BTK) Clinical Trial. This global, multi-center randomized study is intended to analyze the efficacy of the Lutonix Drug Coated Balloon (:DCB) to treat critical limb ischemia (CLI), thereby expanding treatment options for peripheral arterial disease.
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