Latham, New York-based AngioDynamics designed Auryon for the treatment of peripheral artery disease (PAD). That includes critical limb ischemia (CLI) and in-stent restenosis (ISR).
Auryon uses revolutionary solid-state laser technology to treat PAD lesions and occlusions effectively. AngioDynamics describes it as 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 system uses a 355nm wavelength laser platform, enabling the use of short UV laser pulses with targeted biological reactions. These offer effectiveness in treating PAD while minimizing the risk of perforation. It also preserves the ability to vaporize lesions without thermal ablation.
It also features aspiration and off-set capability in certain catheter sizes. This enables clinicians to address the risk of embolization and to treat all lesion types. The system also answers a need for non-surgical intervention options for PAD, AngioDynamics says.
Auryon received FDA 510(k) clearance in 2020 and has treated more than 50,000 patients in the U.S. to date. CE mark enables AngioDynamics to bring its PAD treatment to Europe and expands the company’s reach within the valuable market.
“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 SVP and GM 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.”
