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Safety profile of Philips low-dose drug-coated balloon reaffirmed

By 13th March 2020No Comments

Philips has announced the four-year results of the randomized controlled ILLUMENATE Pivotal trial in the U.S. With an excellent follow-up compliance rate of over 95% in a highly complex disease patient cohort, the data show similar mortality rates through four years for patients treated with Stellarex compared to those treated with the current standard of care (plain balloon angioplasty). The results were presented at the recent Leipzig Interventional Course in January by Dr. Sean Lyden,  co-Primary Investigator for the ILLUMENATE Pivotal trial.

The four-year ILLUMENATE Pivotal trial data are the latest data from a series of trials evaluating the safety and efficacy of the Philips Stellarex .035″ low-dose 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 four-year data from the ILLUMENATE Pivotal trial further substantiates the three-year results that were presented at LINC 2019 and published in Circulation in 2019,” said Sean Lyden, MD. “The high compliance follow-up rate further affirms the findings of these data in a complex patient population.

The study’s patient population is complex with a high proportion suffering from severely calcified lesions. The mortality rate at four years was virtually identical between the two patient groups, at 15.6% for the Stellarex patient group and 15.2% for the control group. Secondary safety outcomes were also similar across the two groups. The four-year data also show a clinically relevant lower rate of clinically-driven target lesion revascularization (CD-TLR) in the Stellarex DCB patient group of 28.2%, vs 34.1% in the control group. CD-TLR is a commonly used indicator of treatment efficacy durability.

The ILLUMENATE Pivotal four-year data builds on the robust, consistent long-term data of the Stellarex clinical evaluation program,” said Chris Landon, general manager, Image Guided Therapy Devices at Philips. “We continue to make relevant data available to healthcare providers in order to help them make an informed decision on the optimal treatment for often complex disease patients with peripheral arterial disease.”

Featuring Philips EnduraCoat technology, a unique coating consisting of a polyethylene glycol excipient with amorphous and crystalline paclitaxel particles dispersed in it, 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, Amsterdam, The Netherlands