AngioDynamics today announced European CE Mark approval of the Auryon Atherectomy System, a technology for the treatment of Peripheral Artery Disease (PAD), including Critical Limb Ischemia (CLI) and In-Stent Restenosis (ISR).
The Auryon Atherectomy System uses solid-state laser technology to treat PAD lesions and occlusions. The company said Auryon is the first laser atherectomy system to treat lesions of any type, length, or location (above and below the knee), with minimal impact on vessel walls.
The Auryon Atherectomy System, which received FDA 510(k) clearance in 2020, has treated more than 50,000 patients in the United States. The recent CE Mark approval now provides patients with PAD in the European Union access to the Auryon System’s advanced laser platform. This approval also expands the Company’s reach to a global PAD market valued at $1.1 billion.
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. 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 minimizing the risk of perforation and preserving the ability to vaporize lesions without thermal ablation.
The Auryon Atherectomy System features aspiration and off-set capability in certain catheter sizes, allowing clinicians to address the risk of embolization and to treat all lesion types, while answering a need for non-surgical intervention options for PAD, including ISR, and CLI.
Nicolas Shammas, MD, and the Midwest Cardiovascular Research Foundation have published a prospective, multi-center, single-arm investigation examining the use of the Auryon laser system in patients with below-the-knee critical limb ischemia (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 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 6 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.