Royal Philips has reported the four-year results from the ILLUMENATE European Randomised Controlled Trial (EU RCT), evaluating its Stellarex low-dose drug-coated balloon (DCB) in patients with peripheral arterial disease.
The company noted that Stellarex DCB cohort demonstrated similar all-cause mortality compared with the control arm through four years.
The analysis included missing data found post hoc to accomplish follow-up compliance of 93.9%, strengthening the robustness of the statistical analysis.
It is the second RCT, which validates the long-term safety profile of Philips’ Stellarex low-dose DCB.
Earlier, Philips published data on the ILLUMENATE Pivotal trial, which indicated similar mortality rates, confirming the long-term safety profile of the device.
Philips Image Guided Therapy Devices general manager Chris Landon said: “The ILLUMENATE EU RCT results now establish Stellarex as the only paclitaxel DCB that has shown a consistent lack of statistical difference in mortality compared with PTA at each annual follow-up through four years across two randomised controlled trials.
“We continue to proactively communicate relevant clinical findings to ensure physicians can make the best-informed decision for each patient.”
The Stellarex .035” DCB, which features Philips EnduraCoat technology, has a unique coating, consisting of a polyethene glycol excipient with amorphous and crystalline paclitaxel.
EnduraCoat technology enables a low therapeutic drug dose and offers efficient drug transfer and effective drug residency along with high coating durability and minimal particulate loss.
Philips’ Image-Guided Therapy business offers procedural solutions of systems, smart devices, disease-specific software and services for minimally invasive procedures.