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.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
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.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalData“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.
