AngioDynamics Gets EU Approval for Auryon Atherectomy System

AngioDynamics has received CE mark approval for its Auryon atherectomy system, a technology to treat peripheral artery disease (PAD), including critical limb ischemia (CLI) and in-stent restenosis (ISR).
 
Auryon uses solid-state laser technology to treat PAD lesions and occlusions. According to the company, it’s 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 gained U.S. Food and Drug Administration (FDA) 510(k) clearance in 2020 and has been used to treat more than 50,000 patients in the U.S.
 
The technology underlying Auryon was shown in clinical studies to be effective to treat lesions ranging from soft plaque to severely calcified, according to AngioDynamics. It uses a 355 nm wavelength laser platform, enabling use of short UV pulses with targeted biological reactions effective to treat PAD, which minimizing perforation risk and keeping the ability to vaporize lesions without thermal ablation.

---

READ MORE: AngioDynamics Shares Positive Study Results for AlphaVac System

---

Auryon features aspiration and off-set capability in some catheter sizes so clinicians can address embolization risk and treat all lesion types.
 
“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 VP 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.”