Amsterdam, The Netherlands - Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced its response to the U.S. Food and Drug Administration’s (FDA) Letter to Health Care Providers regarding treatment of peripheral artery disease (PAD) in the superficial femoropopliteal artery (SFA) with paclitaxel-coated devices.
Importantly, the FDA recommendation continues to provide access to paclitaxel-coated therapies for patients suffering from PAD, while emphasizing the need for physicians to discuss the benefits and risks of therapy and diligently monitor their patients. For patients at high risk of restenosis, the letter outlines that physicians may determine that the benefits of treatment with paclitaxel-coated devices outweigh the risks.
Philips remains very confident in the safety and performance of its unique Stellarex low-dose drug-coated balloon (DCB)  as a treatment option for patients with PAD, including the durable primary patency (maintained blood flow) demonstrated in complex patients studied in randomized controlled trials at three years. In addition, an analysis  of two randomized controlled trials has shown no difference in mortality between patients treated with Stellarex DCB versus those treated with percutaneous transluminal angioplasty (PTA) through three years, with no device-related deaths.