BD (NYSE: BDX) today touted the results of a clinical trial that showed “statistically significant safety equivalence” between its Lutonix 014 drug-coated balloon (DCB) and a standard angioplasty catheter (PTA) in treating narrowed or obstructed arteries below the knee.
The trial’s primary safety endpoint—freedom from composite all-cause death, above the ankle or major reintervention of the treated limb through 30 days—was met in both the proportional and binary and Kaplan Meier analyses of patient survival following a medical procedure. BD presented the trial results during a late-breaking clinical trials session at the Vascular Interventional Advances (VIVA) conference in Las Vegas.
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