AngioDynamics’ Auryon Atherectomy System Receives European CE Mark Approval

September 3, 2024—AngioDynamics, Inc. announced European CE Mark approval of the Auryon atherectomy system for the treatment of peripheral artery disease (PAD), including critical limb ischemia (CLI) and in-stent restenosis (ISR). In the United States, Auryon received FDA 510(k) clearance in 2020.

According to the company, the Auryon laser atherectomy system uses solid-state laser technology to treat PAD lesions and occlusions. It treats lesions of any type, length, or location (above and below the knee) with minimal impact on the vessel wall.

AngioDynamics stated that its technology underlying the Auryon system has been shown in clinical studies to be effective in treating lesions ranging from soft plaque to severely calcified.

As noted in the press release, the system uses a 355-nm wavelength laser platform, enabling the use of short ultraviolet (UV) laser pulses with targeted biological reactions that are effective in treating PAD while minimizing the risk of perforation and preserving the ability to vaporize lesions without thermal ablation.

Other features include aspiration and off-set capability in certain catheter sizes, allowing clinicians to address the risk of embolization and to treat all lesion types, while providing a nonsurgical intervention options for PAD, including CLI and ISR.

The safety and efficacy of the Auryon laser system to treat a wide range of complex patients with PAD continues to be demonstrated in clinical studies.

The company noted that 30-day results from the investigator-initiated Auryon BTK study conducted by the Midwest Cardiovascular Research Foundation in Davenport, Iowa, under the guidance of Principal Investigator Nicolas Shammas, MD, recently were published by Dr. Shammas et al in the American Journal of Cardiology (2024;219:1-8).

The prospective, multicenter, single-arm Auryon BTK study examined the use of the Auryon laser system in patients with BTK CLI. 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 revascularization. The commencement of the study was announced by AngioDynamics in April 2022.

The company noted that the PATHFINDER Registry further supported these findings, showing no flow-limiting dissections and significant improvement in ankle-brachial index, Rutherford classification, and Walking Impairment Questionnaires at both 6 and 12 months in a real-world clinical setting.

Tony S. Das, MD, et al published the findings, “Solid state, pulsed-wave 355 nm UV laser atherectomy debulking in the treatment of infrainguinal peripheral arterial disease: The Pathfinder Registry,” in Catheterization & Cardiovascular Interventions (2024;103:949-962).