AngioDynamics today announced European CE mark approval of the Auryon atherectomy system, designed for the treatment of peripheral arterial disease (PAD), including chronic limb-threatening ischaemia (CLTI) and in-stent restenosis (ISR).
The Auryon atherectomy system uses solid-state laser technology to treat PAD lesions and occlusions. A press release notes that Auryon is the first laser atherectomy system to efficiently treat lesions of any type, length, or location (above and below the knee), with minimal impact on vessel walls.
“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 arterial disease,” said Laura Piccinini, AngioDynamics senior vice president and general manager of endovascular therapies and international. “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. We are committed to supporting physicians with innovative technologies that empower them to deliver the best possible care when treating some of the most challenging cases of this disease.”
AngioDynamics states that the Auryon atherectomy system, which received US Food and Drug Administration (FDA) 510(k) clearance in 2020, has treated over 50,000 patients in the USA. The recent CE mark approval now provides patients with PAD in the European Union access to the Auryon system’s laser platform.
The technology underlying the Auryon atherectomy system has been shown in clinical studies to be effective in treating lesions ranging from soft plaque to severely calcified, a press release reports. The system uses a 355nm wavelength laser platform, enabling the use of short UV laser pulses with targeted biological reactions that are effective in treating PAD while minimising the risk of perforation and preserving the ability to vaporise lesions without thermal ablation.
The press release continues that the Auryon atherectomy system features aspiration and off-set capability in certain catheter sizes, allowing clinicians to address the risk of embolisation and to treat all lesion types, while answering a need for non-surgical intervention options for PAD, including ISR, and CLTI.
Nicolas Shammas and the Midwest Cardiovascular Research Foundation (Davenport, USA) have published a prospective, multicentre, single-arm investigation examining the use of the Auryon laser system in patients with below-the-knee CLTI. The study demonstrated that the Auryon laser system effectively reduced residual stenosis to ≤30% in the majority of patients post-treatment, without any cases of target lesion revascularisation.
The recently published PATHFINDER registry further supports these findings, showing no flow-limiting dissections and significant improvement in ankle-brachial index (ABI), Rutherford classification, and Walking Impairment Questionnaires at both six and 12 months in a real-world clinical setting.
These results add to a growing body of evidence indicating that the Auryon laser system is a safe and effective treatment option for a wide range of complex patients with PAD.
