Avinger’s image-guided atherectomy system gets FDA pre-marketing clearance
Avinger’s (NASDAQ:AVGR) Pantheris SV (small vessel) image-guided atherectomy system, indicated for the diagnosis and treatment peripheral artery disease (PAD), has received 510(k) clearance from the FDA.
Atherectomy is a minimally-invasive treatment for PAH, where plaque is removed from blood vessels using a catheter-based device. Currently, doctors rely on x-ray or tactile feedback to guide atherectomies. Pantheris SV uses Avinger’s Lumivascular platform technology to capture images from inside the artery during these procedures.
“Pantheris SV uses a combination of directional atherectomy with onboard image-guidance to provide several potential clinical advantages, including an enhanced safety profile, the ability to maximize luminal gain without causing vascular injury, and precise vessel measurement capabilities,” Jaafer Golzar, Avinger’s CMO, said in a statement.
Pantheris SV, indicated for PAD of small vessels ranging from two-to-four millimeters in diameter, received CE Mark in October 2018. Avinger is planning a limited launch of Pantheris SV at several sites in the U.S.