FDA approves Philips’ 200mm and 150mm Stellarex 0.035” low-dose DCBs

Royal Philips has received FDA approval for its new 200mm and 150mm Stellarex 0.035” low-dose drug-coated balloons for the treatment of de novo and restenotic lesions in native superficial femoral or popliteal arteries. Primary safety analysis of Philips Stellarex DCB three-year data showed no difference in mortality between patients treated with the Philips Stellarex DCB and those treated with percutaneous angioplasty, the current standard of care. All Philips’ Stellarex DCBs have a unique coating of a polyethylene glycol excipient with amorphous and crystalline paclitaxel particles dispersed in it which provides efficient drug transfer and effective drug residency together with high coating durability and minimal particulate loss, facilitating a low therapeutic drug dose.
Chris Landon, Philips’ General Manager, Image Guided Therapy Devices, said: “With its unique coating, Stellarex is unlike any other DCB in the industry for the treatment of PAD. 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 U.S. 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.”