October 16, 2019 — Amsterdam, the Netherlands – Royal Philips introduced two new balloons to its Stellarex 0.035” low-dose drug-coated balloon (DCB) portfolio. The new 200mm and 150mm Stellarex 0.035” 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 and expand the Stellarex portfolio, which has a proven significant treatment effect and high safety profile. The 200mm and 150mm Stellarex 0.035” 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). 34% 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.
“With its unique coating, Stellarex is unlike any other DCB in the industry for the treatment of PAD,” said Chris Landon, General Manager, Image Guided Therapy Devices at Philips. “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.”
All Philips’ Stellarex DCBs feature EnduraCoat technology, a unique 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″ 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 industry’s most extensive and rigorous safety assessments of a paclitaxel-based device.
The 200mm and 150mm Stellarex 0.035” low-dose DCBs are the latest innovation in Philips’ unique portfolio of devices to support image-guided therapy procedures. Offering precise, accurate and efficient tools helps physicians decide, guide, treat and confirm the right therapy for the right patient at the point of care. In addition to Stellarex DCBs, Philips has leading positions in IVUS (intravascular ultrasound) catheters that produce ultrasound images of the interior of blood vessels, as well as FFR (fractional flow reserve) and iFR (instantaneous free wave) catheters that are used to assess the blood flow. iFR technology is unique to Philips. Our integrated solutions advance minimally invasive procedures for patients with coronary artery disease, peripheral artery disease and lead extraction indications.