October 15, 2019 — Royal Philips introduced two new balloons to its Stellarex 0.035-inch low-dose drug-coated balloon (DCB) portfolio. The new 200mm and 150mm Stellarex 0.035-inch low-dose DCBs have received approval from the U.S. Food and Drug Administration (FDA) for the treatment of de novo and restenotic lesions in native superficial femoral or popliteal arteries, both arteries in the upper leg. The new balloons broaden physicians’ treatment options for peripheral artery disease (PAD) patients with a high risk of restenosis. The 200mm and 150mm Stellarex 0.035-inch low-dose DCBs are now available in the U.S. and will be rolled out to other markets in due course.
PAD affects more than 200 million people worldwide . If left untreated, it can result in critical limb ischemia (CLI), and 34 percent of patients with CLI undergo amputation within one year of diagnosis. Broadening physicians’ treatment options helps ensure more PAD patients will receive treatment before the disease progresses.
All Philips’ Stellarex DCBs feature EnduraCoat technology, a coating consisting of a polyethylene glycol excipient with amorphous and crystalline paclitaxel particles dispersed in it. The coating provides efficient drug transfer and effective drug residency coupled with high coating durability and minimal particulate loss, thereby enabling a low therapeutic drug dose. The Stellarex balloon 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.
The results of third-party analyses of patient-level data from worldwide clinical trials of the Philips Stellarex 0.035-inch low-dose DCB in lengths under 150mm were recently published in Circulation, a peer-reviewed journal of the American Heart Association. Primary safety analysis of Philips Stellarex DCB three-year data, comprising a large published, pooled set of randomized controlled trial (RCT) data for a single paclitaxel-based device, showed no difference in mortality between patients treated with the Philips Stellarex DCB and those treated with percutaneous angioplasty, the current standard of care. The analyses represent one of the industry’s most extensive and rigorous safety assessments of a paclitaxel-based device.
For more information: www.usa.philips.com/healthcare
2. Gray W.A., Jaff M.R., Parikh S.A., et al. Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years. Circulation, published online Sept. 30, 2019. https://doi.org/10.1161/CIRCULATIONAHA.119.040518