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Philips says latest trial data add to confidence in Stellarex program.

Royal Philips announced the three-year results from the ILLUMENATE Pivotal trial and the ILLUMENATE European randomized clinical trial, EU RCT. These two trials are part of a series of five trials evaluating the safety and efficacy of Stellarex .035 low-dose DCB to restore and maintain blood flow in the superficial femoral artery and popliteal arteries of patients with peripheral arterial disease. The results were evaluated compared to treatment with uncoated balloons, the current standard of care. "The three year data of the ILLUMENATE Pivotal trial and ILLUMENATE EU RCT add to the robust and consistent multi-year data of the Stellarex program," said S. Jay Mathews, M.D. "The demonstrated durability of Stellarex in the complex patient pool of the ILLUMENATE Pivotal trial, which are patients that are at high risk for restenosis, a recurring blockage, is unique in the industry. Moreover, we continue to see no significant difference in mortality rates between patients treated with Stellarex and those treated with uncoated balloons, which confirms our confidence in the safety profile of Stellarex." "We are committed to providing clinically proven image-guided therapy solutions that enhance the procedure and positively impact patient outcomes," said Bert van Meurs, Chief Business Leader, Image Guided Therapy at Royal Philips. "Stellarex is the only low-dose drug-coated balloon with a proven treatment effect at three years compared to the existing standard-of-care in the U.S. and Europe. The combination with our interventional imaging systems, such as the successful Azurion platform, our recently-introduced IntraSight intravascular diagnostic application platform, and associated services, enables clinicians to decide, guide, treat and confirm the appropriate peripheral vascular treatment."

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Publication:The Fly
Date:May 29, 2019
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