Royal Philips has reported positive two-year results from the ILLUMENATE European randomised clinical trial (EU RCT) of the Stellarex 0.035” drug-coated balloon (DCB) to treat peripheral arterial disease (PAD).
Designed to restore and maintain blood flow to arteries, the Stellarex DCB was originally launched by Spectranetics, which was acquired by Philips last month.
The ILLUMENATE trial compared Stellarex with an uncoated balloon angioplasty in 328 patients at 18 centres in Germany and Austria.
Demonstrating the efficacy of Stellarex, the results showed maintenance of blood flow through the treated segment of the diseased artery in 75.9% of patients at 24 months, compared to 61% with an uncoated balloon.
The results are said to indicate higher efficacy, patency results, and longer treatment durability for Stellarex.
Royal Philips Image-Guided Therapy Devices business leader Christopher Barys said: “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.”
Assessments for the ILLUMENATE EU RCT were performed by angiographic and duplex ultrasound core laboratories, while funding was provided by Philips Spectranetics.
The trial is part of the ILLUMENATE series that comprised five studies for the evaluation of the Stellarex DCB in different groups of patients compared to an uncoated percutaneous transluminal angioplasty (PTA) balloon.