Philips has added two new balloons to its portfolio of Stellarex 0.035 low-dose drug-coated balloons, following approval from the FDA. The new 200mm and 150mm Stellarex 0.035 low-dose balloons are now approved and available, in the USA, for the treatment of de novo and restenotic lesions in native superficial femoral or popliteal arteries. A press release reports that the balloons will be rolled out to other markets in “due course”.
The Stellarex balloon, therefore, is now available in 40, 60, 80, 100, 120, 150, and 200mm lengths for the treatment of lesions in the superficial femoral and popliteal arteries with vessel diameters of 4-6mm. All Philips’ Stellarex drug-coated balloons feature EnduraCoat technology, which the press release describes as a unique coating consisting of a polyethylene glycol excipient with amorphous and crystalline paclitaxel particles dispersed in it. The coating is designed to provide efficient drug transfer and effective drug residency coupled with high coating durability and minimal particulate loss, thereby enabling a low therapeutic drug dose.
The results of third-party analyses of patient-level data from worldwide clinical trials of the Stellarex 0.035″ low-dose drug-coated balloons, in lengths under 150mm, were recently published in Circulation. Primary safety analysis of Stellarex drug-coated three-year data—comprising a large published, pooled set of randomised controlled trial data for a single paclitaxel-based device— showed no difference in mortality between patients treated with the Stellarex drug-coated balloon and those treated with percutaneous angioplasty. According to the press release, the analyses represent one of industry’s most extensive and rigorous safety assessments of a paclitaxel-based device.
Chris Landon, general manager, Image Guided Therapy Devices at Philips, says: “With its unique coating, Stellarex is unlike any other drug-coated balloon in the industry for the treatment of peripheral arterial disease. Stellarex is the only low-dose drug-coated balloon with a proven treatment effect at three years compared to the existing standard of care in the USA and Europe. By expanding our range of Stellarex balloons, we are adding to the treatment options that physicians can use to provide optimal care for each patient with peripheral arterial disease.”