Institute of Good Manufacturing Practices India®

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AngioDynamics received CE mark for atherectomy system

AngioDynamics (Nasdaq: ANGO) won CE mark approval for its Auryon atherectomy system, designed to treat peripheral artery disease (PAD), including critical limb ischemia (CLI) and in-stent restenosis (ISR). Developed in Latham, New York, Auryon utilizes innovative solid-state laser technology for effective treatment of PAD lesions and occlusions with minimal impact on vessel walls.

The system operates with a 355nm wavelength laser, delivering short UV pulses that target biological reactions, reducing the risk of perforation and avoiding thermal ablation while effectively vaporizing lesions. It includes aspiration and offset features in certain catheter sizes to manage embolization risk and address various lesion types.

Having already received FDA 510(k) clearance in 2020 and treated over 50,000 U.S. patients, the CE mark approval allows AngioDynamics to expand its PAD treatment to Europe, broadening its market presence.