AngioDynamics Gets Expanded Clearance for Auryon Atherectomy System
AngioDynamics has received an expanded 510(k) marketing clearance from the FDA for its Auryon laser atherectomy system for treating patients with peripheral artery disease.
The new clearance is for use of the system’s 2 millimeter and 2.35 millimeter catheters for removing adjacent blood clots when treating narrowing in arteries below the groin. The catheters can also be used for removing clots in stents.
The laser procedure does not damage surrounding tissue, so patients can be discharged in less than 24 hours without the need for an intensive care unit bed or overnight stay.
The system has been used to treat more than 21,000 patients in the U.S. since its launch in September 2020, the company said.