Patient-Level Data Confirm Safety Profile of Stellarex Low-Dose, Drug-Coated Balloon

Royal Philips, a global leader in health technology, announced the results of a patient-level meta-analysis that confirms the safety profile of its Stellarex drug-coated balloon (DCB) at four years. Including data from two major randomized controlled trials (RCTs), the results show no difference in mortality between patients treated with the Stellarex DCB and those treated with percutaneous angioplasty (PTA), the current standard of care. 
 
The meta-analysis found that over four years, there was no significant difference in survival among patients treated with the Stellarex DCB (85.7 percent) compared to those treated with PTA (85.6 percent). The data includes two Stellarex RCTs: the ILLUMENATE EU RCT and the ILLUMENATE Pivotal RCT, comprised of 589 patients in the United States and Europe followed up to four years with a high compliance on vital status data.
 
“The meta-analysis reinforces previously presented results from the ILLUMENATE RCTs, demonstrating low mortality rates each year through four years, with no difference in rates between the two patient cohorts,” said Sean Lyden, M.D., chairman of the Department of Vascular Surgery, Cleveland Clinic (U.S.), who presented the data. Dr. Lyden is also co-primary investigator for the ILLUMENATE Pivotal trial, one of the two RCTs included in the meta-analysis, and a paid consultant to Philips. “This independent, patient-level meta-analysis continues to provide consistent, long-term data for a large group of patients.”
 
In addition to demonstrating no significant difference in all-cause mortality between patients treated with the Stellarex DCB and those treated with PTA (14.3 percent vs. 14.4 percent), the results of the meta-analysis also show no difference in cardiovascular mortality (3.6 percent vs. 4 percent) and non-cardiovascular mortality (10.8 percent vs. 10.9 percent).
 
“The results of this study confirm the safety and performance of our unique Stellarex low-dose drug-coated balloon,” said Chris Landon, senior vice president and 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 each patient with peripheral arterial disease. Stellarex, with its low drug dose and unique drug coating composition, is a logical choice for those who require 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. 
 
Philips’ Image Guided Therapy business provides complete procedural solutions of systems, smart devices, disease-specific software and services for minimally invasive procedures, helping caregivers decide, guide, treat and confirm the right therapy for each patient during their procedure.