Avinger’s Tigereye ST Image-Guided CTO Crossing System Cleared by FDA

April 26, 2023—Avinger, Inc. announced FDA 510(k) clearance for Tigereye ST, the company’s next-generation image-guided chronic total occlusion (CTO) crossing system. Avinger advised it will initially launch Tigereye ST on a limited basis with plans to expand to full commercial launch in the United States in the third quarter of 2023.

According to the company, Tigereye ST incorporates design upgrades to the tip configuration and catheter shaft to increase crossing power and procedural success in challenging lesions. Additionally, the device includes enhancements for ease of image interpretation during the procedure. The first-generation TigerEye device was launched in January 2021.

The new Tigereye ST provides high-definition real-time intravascular imaging, user-controlled deflectable tip, and fast rotational speeds that were introduced to the platform in 2021. The device specifications include a 140-cm working length, 5-F sheath compatibility, and a low crossing profile for the treatment of lesions in the peripheral vessels both above and below the knee.

Jaafer Golzar, MD, who is Avinger’s chief medical officer as well as an interventional cardiologist experienced in treating patients with peripheral CTOs, commented in the company’s press release, “Treating CTOs presents significant technical challenges to physicians, and we have a limited set of minimally invasive tools to provide safe and effective outcomes for this high-risk patient population.

“With Tigereye ST, a physician can precisely control the device to stay safely within the lumen while successfully crossing challenging lesions. Intraluminal crossing provides a wider variety of treatment options, results in less potential for vascular injury, and provides better long-term clinical outcomes for patients.”

Avinger’s Lumivascular technology incorporates an onboard image-guidance system to allow interventionalists to see inside the artery during an atherectomy or CTO-crossing procedure by using optical coherence tomography (OCT) imaging. During the procedure, high-resolution intravascular OCT images are displayed on Avinger’s Lightbox console in real-time to guide therapy.