– Two-year data from the ILLUMENATE European randomized clinical trial (EU RCT) validates durable clinical performance of Stellarex low-dose drug-coated balloon
– Trial includes 328 peripheral arterial disease patients from 18 centers across Germany and Austria
AMSTERDAM and LAS VEGAS, Sept. 15, 2017 /PRNewswire/ — Royal Philips (NYSE: PHG; AEX: PHIA), a global leader in health technology, announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating the efficacy of Philips Spectranetics’ Stellarex .035″ drug-coated balloon (DCB) for peripheral arterial disease (PAD) in comparison to uncoated balloon angioplasty. Marianne Brodmann, M.D., of the Medical University of Graz in Austria, presented the data today as a late-breaking trial at the Vascular Interventional Advances (VIVA 17) Annual Conference.
The ILLUMENATE EU RCT, which is part of a series of five trials evaluating the safety and efficacy of Stellarex for superficial femoral artery and popliteal disease, includes 328 PAD patients from 18 centers across Germany and Austria and compares the Stellarex DCB to an uncoated angioplasty balloon. The results show that at 24 months, 75.9% of patients treated with Stellarex maintained blood flow through the treated segment of the diseased artery, assessed through blinded core-lab adjudicated patency. Only 61.0% of patients treated with an uncoated balloon still maintained blood flow at 24 months. The data shows that Stellarex demonstrates higher efficacy and patency results, and longer treatment durability compared to an uncoated balloon, which is the current standard of care in the United States.
“The Stellarex DCB produced durable results in this rigorous trial, validating earlier findings among the ILLUMENATE trial series,” stated Marianne Brodmann, M.D. “These consistent, top-tier outcomes are achieved with a low-dose balloon.* Stellarex is…