AngioDynamics has secured European CE mark for the Auryon Atherectomy System, a laser technology used for the treatment of peripheral artery disease (PAD).
The system, which received US Food and Drug Administration (FDA) clearance in 2020, is intended to treat in-stent restenosis (ISR) lesions and critical limb ischemia (CLI) in infrainguinal arteries of PAD patients.
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Auryon uses a 355nm wavelength laser platform, where pulsed laser energy is delivered through a catheter to precisely remove plaque from arteries, restoring blood flow. This process, known as atherectomy, clears the pathway for blood to flow more freely. US-based AngioDynamics inherited the system when it acquired medical device firm Eximo Medical in October 2019, in a deal worth $66m.
Approval of Auryon in the EU was supported by data from various studies. Data published in the Cardiovascular Revascularization Medicine journal highlighted that procedural success was achieved in 85.5 % of patients, with none of the 55 enrolled patients experiencing procedure-related complications.
The system was also evaluated in the PATHFINDER post-market registry study, where treatment with the device showed no flow-limiting dissections and significant improvement in Ankle-Brachial Index (ABI), Rutherford classification, and Walking Impairment Questionnaires at both six and 12 months.
PAD is a common vascular condition that affects both quality of life and life expectancy with an associated increased risk of cardiovascular events. PAD patients have narrowed arteries, usually due to atherosclerosis, where fatty deposits build up on the artery walls, restricting blood flow. GlobalData epidemiologists estimate there were 18,386,656 diagnosed prevalent cases of PAD globally in 2023, which are expected to grow to 18,751,586 cases by this year.
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By GlobalDataAngioDynamics’ senior vice president Laura Piccinini said: “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.”
In February 2024, AngioDynamics sold its peripherally inserted central catheter (PICC) and Midline product portfolios to Spectrum Vascular for up to $45m. According to the company, the sale forms part of efforts to optimise its portfolio and restructure its manufacturing footprint.
