Philips tests Stellerax low-dose DCB in PAD patients for two years

Royal Philips (NYSE:PHG) today touted two-year data from the Illumenate trial evaluating the efficacy of its Stellarex 0.35” drug-coated balloon in patients with peripheral arterial disease.

The trial compared the company’s DCB with uncoated balloon angioplasty. The device, which Philips acquired when it bought Spectranetics in August, delivers a dose of just 2 micrograms of paclitaxel per square millimeter – a lower dose compared to other DCBs on the market.

The Illumenate trial included 328 patients with peripheral arterial disease, Philips said, and at 24 months, 75.9% of patients treated with Stellarex maintained blood flow through the treated section of the diseased artery. In comparison, just 61% of patients treated with an uncoated balloon maintained blood flow after 24 months.

“The Stellarex DCB produced durable results in this rigorous trial, validating earlier findings among the Illumenate trial series,” Dr. Marianne Brodmann said in prepared remarks. “These consistent, top-tier outcomes are achieved with a low-dose balloon. Stellarex is the first low-dose DCB to demonstrate a significant treatment effect at two years.”

“We are committed to providing proven clinical solutions that positively impact patient outcomes,” Christopher Barys, Philips’ Image Guided Therapy Devices business leader, added. “We are proud to have the only low-dose drug-coated balloon with a proven treatment effect at two years compared to the current endovascular standard of care in the U.S. The addition of Stellarex in the Philips portfolio through the Spectranetics acquisition reinforces our commitment to helping physicians decide, guide, treat and confirm the right therapy for their patients.”