FDA Approves DBC to Treat PAD in Upper Leg

On Jan. 5 the Food and Drug Administration (FDA) approved the drug-coated balloon (DBC) IN.PACT for the treatment of peripheral artery disease (PAD) in the upper leg. According to Medtronic’s release, the DBC will reopen superficial femoral and popliteal arteries, narrowed or blocked by plaque, and deliver paclitaxel to the artery walls to ensure the arteries remain open. During the trial period, IN.PACT “demonstrated the lowest rate of clinically driven target lesion revascularization at one year ever reported for an interventional treatment of PAD in the superficial femoral artery”.

Read the Medtronic’s announcement.

Keywords: Femoral Artery, Leg, Lower Extremity, Paclitaxel, Peripheral Arterial Disease, Popliteal Artery, United States Food and Drug Administration


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