AngioDynamics, a medical technology company dedicated to enhancing blood flow and advancing cancer treatments, has received European CE Mark approval for its Auryon Atherectomy System.
The technology is designed to treat peripheral artery disease (PAD), including critical limb ischemia (CLI) and in-stent restenosis (ISR).
The Auryon Atherectomy System uses solid-state laser technology to address PAD lesions and occlusions.
It is claimed to be the first laser atherectomy system capable of treating lesions of any type, length, or location while minimising the impact on vessel walls.
The advanced laser system received US Food and Drug Administration (FDA) 510(k) clearance in 2020. The latest CE Mark approval now extends access to this technology to patients with PAD in the European Union.
According to AngioDynamics, the Auryon System has demonstrated its effectiveness in treating a range of lesions, from soft plaque to severely calcified deposits in clinical studies.
It utilises a 355nm wavelength laser platform, which employs short UV laser pulses to produce targeted biological reactions. This method treats PAD while reducing the risk of vessel perforation and preserving the ability to vaporise lesions without thermal ablation.
Additionally, the advanced laser technology includes aspiration and offset capabilities in certain catheter sizes, addressing the risk of embolisation and allowing for the treatment of various lesion types.
AngioDynamics senior vice president and endovascular therapies and international general manager Laura Piccinini said: “The CE Mark approval of the Auryon System is a significant milestone that underscores our commitment to bringing safe and effective solutions to healthcare professionals treating peripheral artery disease.
“This approval validates the clinical value of the Auryon System and allows us to expand our presence in Europe, as the prevalence of PAD continues to grow across the region.”
In a prospective, multi-centre, single-arm study, the laser system effectively reduced residual stenosis to 30% or less in most patients after treatment, with no cases of target lesion revascularisation.
The findings were supported by data from a recently published PATHFINDER registry. The data demonstrated that the Auryon System led to no flow-limiting dissections and improvements in Ankle-Brachial Index (ABI), Rutherford classification, and Walking Impairment Questionnaires.
In May, AngioDynamics secured CE Mark approval for the AlphaVac F1885 System to remove thrombi or emboli from the pulmonary arteries and for the treatment of pulmonary embolism (PE).
