LATHAM, N.Y.--(BUSINESS WIRE)--AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced European CE Mark approval of the Auryon Atherectomy System, an innovative technology for the treatment of Peripheral Artery Disease (PAD), including Critical Limb Ischemia (CLI) and In-Stent Restenosis (ISR)1,2,3.

The Auryon Atherectomy System uses revolutionary solid-state laser technology to treat PAD lesions and occlusions effectively. Auryon is the first laser atherectomy system to efficiently treat lesions of any type, length, or location (above and below the knee)1,2,3, 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 artery 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 region4. 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.”

The Auryon Atherectomy System, which received FDA 510(k) clearance in 2020, has treated over 50,000 patients in the United States5. 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 billion5.

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 calcified1,2,3. 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 ablation1,3,8,9.

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 types1, while answering a need for non-surgical intervention options for PAD, including ISR, and CLI.

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