Jun 26, 2020

New data reconfirms long-term safety profile of the Philips Stellarex low-dose Drug-Coated Balloon

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the four-year results from the ILLUMENATE European Randomized Controlled Trial (EU RCT). The Stellarex DCB cohort demonstrated similar all-cause mortality compared with the control arm through four years. This analysis included missing data found post hoc to achieve a follow-up compliance of 93.9%, increasing the robustness of the statistical analysis. Along with the recently-published data on the ILLUMENATE Pivotal trial, this is the second RCT which has indicated similar mortality rates, further validating the long-term safety profile of Philips’ Stellarex low-dose Drug-Coated Balloon [1]. The data were presented in the evening of 25 June as part of Vascular Interventional Advances’ (VIVA) first-ever late-breaking clinical trials livestream.

The four-year ILLUMENATE EU RCT data are the latest from a series of trials evaluating the safety and efficacy of the Philips Stellarex .035″ DCB in restoring and maintaining blood flow in the superficial femoral artery and popliteal arteries of patients with peripheral arterial disease. The results were evaluated compared to percutaneous transluminal angioplasty (PTA) treatment with uncoated balloons, the current standard of care. The mortality rate at four years shows no statistical difference between two patient groups, at 17.7% for the Stellarex patient group and 14.1% for the control group. Secondary safety outcomes were also similar across the two groups.

“These latest data from the ILLUMENATE EU RCT study add to the ILLUMENATE Pivotal RCT results and continue to demonstrate no statistical difference in mortality when comparing the DCB and PTA arms of the trial,” said William Gray, MD, FACC, FSCAI, and President of the Lankenau Heart Institute, an investigator for the Stellarex clinical trials who presented the results during the livestream.

“The results from the ILLUMENATE EU RCT trial continue to demonstrate durable long-term results at a high rate of follow-up compliance,” said Marianne Brodmann, MD, Professor, vascular specialist at the Medical University of Graz, Austria and a primary investigator for the trial.

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 randomized controlled trials.

Chris Landon

General Manager, Image Guided Therapy Devices at Philips.

“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 randomized controlled trials,” said Chris Landon, General Manager, Image Guided Therapy Devices at Philips. “We continue to proactively communicate relevant clinical findings to ensure physicians can make the best-informed decision for each patient.”

Featuring Philips EnduraCoat technology, a unique coating consisting of a polyethylene glycol excipient with amorphous and crystalline paclitaxel, the 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.

[1] Low-dose DCBs are those that deliver a dose of only 2 micrograms of the drug paclitaxel per square millimeter, which is lower than some other DCBs on the market.

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2019 sales of EUR 19.5 billion and employs approximately 81,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.