Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today 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.