ILLUMENATE assessed the safety and performance of Stellarex drug-coated balloon (DCB) in de novo and restenosis femoropopliteal lesions in a broad patient population. The rigorous 4-year data, building on the ILLUMENATE RCT program, showed favorable safety and efficacy outcomes of the device (8.1% all- cause mortality), and similar efficacy in prespecified cohorts including gender and diabetics. Prior to these findings, there was limited long term-data around all-cause mortality of paclitaxel coated balloons. Freedom from CD-TLR through 4 years was 75.6% showing durable long-term outcomes with this low dose paclitaxel DCB. No mortality signal from DCB therapy emerged during this global study though it was underpowered for mortality.

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