“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,” said William Gray, MD, FACC, FSCAI, President of the Lankenau Heart Institute, and lead author of the safety manuscript. “We are confident in the finding of no difference in mortality rates between patients treated with Stellarex and those treated with PTA.”
As the study sponsor, Philips was involved in study design and data collection, but was not involved in the analysis or interpretation of data. Sean Lyden and William Gray have consulting relationships with Philips, but have not received financial compensation from Philips in connection with their role in this analysis.
“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,” said Chris Landon, general manager Image Guided Therapy Devices at Philips. “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.”
Featuring Philips EnduraCoat technology, a unique coating consisting of a polyethylene glycol excipient with amorphous and crystalline paclitaxel particles dispersed in it, Stellarex .035″ DCB is unlike any other drug-coated balloon for the treatment of peripheral artery disease. EnduraCoat technology provides efficient drug transfer and effective drug residency coupled with high coating durability and minimal particulate loss, thereby enabling a low therapeutic drug dose.
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 (maintained blood flow) in the most complex patient pool ever studied in a DCB randomized clinical trial.