The U.S. Food and Drug Administration granted 510(k) clearance to Avinger Inc.'s Pantheris lumivascular atherectomy system, a surgical device for treating peripheral artery disease.
Peripheral artery disease, or PAD, is characterized by blockage or narrowing of arteries. It mostly affects the legs but also affects the arms, stomach and head, leading to reduced blood flow that can result in severe pain and limit physical mobility.
Atherectomy is a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel.
Avinger said its next-generation Pantheris lumivascular atherectomy system is the first-ever image-guided atherectomy device for treating PAD.
The Redwood City, Calif.-based medical device-maker said PAD is projected to affect more than 21 million people in the U.S. alone by 2020.
