Avinger has received 510(k) clearance from the FDA for its next generation Pantheris Lumivascular atherectomy system, the first-ever image-guided atherectomy device for the treatment of peripheral artery disease (P.A.D.).

Lumivascular is the only technology that combines real-time intravascular imaging with highly effective catheters for the treatment of P.A.D.

The Company intends to launch two versions of this product (standard and extended length nosecone) into initial sites in the United States immediately, and plans to incorporate the new design into the INSIGHT IDE clinical trial currently in progress.

Shares are up 47 percent premarket. VTN