ILLUMENATE trials confirm safety profile of Stellarex .035″ low-dose DCB

Syntactx has analysed data from the ILLUMENATE Pivotal trial and the ILLUMENATE European Randomized Controlled Trial of Philips’ Stellarex .035″ low-dose drug-coated balloon. In those trials, 419 of the 589 participating patients were treated with Stellarex DCB to restore and maintain blood flow to arteries in the upper legs, and 170 patients were treated with an uncoated percutaneous angioplasty balloon. Syntactx also analysed the two Stellarex DCB RCTs in addition to the four Stellarex DCB single-arm studies in the meta-analysis, including 2,495 patients with peripheral artery disease, of which 2,325 were treated with Stellarex DCB to restore and maintain blood flow to arteries in the upper legs. The analysis showed no difference in mortality between patients treated with Stellarex DCB and uncoated PTA through three years, and no device-related deaths or correlation of Stellarex DCB to late all-cause mortality. The same was true in the additional analysis. Stellarex is the only low-dose DCB to demonstrate a significant treatment effect and high safety profile through three years. The ILLUMENATE Pivotal trial showed durable primary patency in the most complex patient pool ever studied in a DCB randomized clinical trial.
Chris Landon, Philips’ general manager Image Guided Therapy Devices, said: “The results of this study, combined with the recently presented three-year efficacy data, confirm our confidence in the safety and performance of our unique Stellarex low-dose drug-coated balloon. We are committed to providing healthcare providers with accurate and transparent data in order to help them make an informed decision on the optimal treatment for patients with peripheral arterial disease. We believe Stellarex, with its low drug dose and unique drug coating composition, is a logical choice for those who need this option.”
William Gray, President of the Lankenau Heart Institute, and lead author of the safety manuscript, said: “After a careful, detailed and appropriately directed analysis of the controlled data available from the Stellarex suite of studies, we have a robust assessment of the patient-level outcomes related to the Stellarex drug-coated balloon. We are confident in the finding of no difference in mortality rates between patients treated with Stellarex and those treated with PTA.”