The Food and Drug Administration (FDA) has approved Lutonix DCB (Lutonix 035 Drug Coated Balloon) Percutaneous Transluminal Angioplasty (PTA) Catheter, the first drug-coated balloon used to re-open arteries in the thigh and knee when narrowed or blocked due to peripheral artery disease (PAD).

The Lutonix DCB has a balloon coated on its outer surface with the drug paclitaxel, which may help to prevent recurrent restenosis after the procedure. During the procedure, the artery is first partially opened with a traditional angioplasty balloon, without a drug coating. The Lutonix DCB is then used to fully open the narrowed portion of the artery and apply the drug to the artery wall. The Lutonix DCB may be used in arteries located in the thigh or the knee.

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The safety and effectiveness of Lutonix DCB was determined from nonclinical testing as well as three clinical studies. The FDA is requiring as a part of the approval that Lutonix Inc. conduct two post-approval studies. One is a five-year post-approval study of 657 patients treated with the Lutonix DCB to further monitor safety and effectiveness. The second is a randomized, single blind, multi-center study which will assess the safety and effectiveness of the Lutonix DCB in women in the U.S., due to differences in observed outcomes in this group as compared to outcomes for the general study population.

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