Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of vascular disease, today announced the company has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for Tigereye® ST, its next-generation image-guided chronic total occlusion (CTO) crossing system.
Tigereye ST expands and advances Avinger's proprietary image-guided CTO product line with compelling new features and benefits. Tigereye ST incorporates design upgrades to the tip configuration and catheter shaft to increase crossing power and procedural success in challenging lesions, as well as design enhancements for ease of image interpretation during the procedure. Tigereye ST continues to provide the high-definition real-time intravascular imaging, user-controlled deflectable tip, and faster rotational speeds introduced to the platform in 2021. Product specifications include a working length of 140 cm, 5 French sheath compatibility, and low crossing profile for treatment of lesions in the peripheral vessels both above and below the knee.
Avinger will initiate a limited launch of Tigereye ST in the current quarter with plans to expand to full commercial availability in the U.S. in the third quarter of 2023.
https://finance.yahoo.com/news/avinger-receives-510-k-clearance-120000372.html
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