FDA Clears Avinger’s Design Changes for Atherectomy Device

California-based medical device company Avinger has received 510(k) clearance for design modifications to its implantable Pantheris Lumivascular atherectomy system.

“The 510(k) submission covered a series of non-significant design changes already incorporated into commercial products and previously documented as letters to file,” the company said.

The modifications were designed to enhance cutting efficiency, increase product reliability, and improve overall ease of use of the system, Avinger said.