Avinger, Inc. announced full commercial launch of its Tigereye® ST next generation image-guided chronic total occlusion (CTO) crossing system. With the initiation of full commercial launch, all current and prospective accounts can now order the Tigereye ST device. Prior to full commercialization, Avinger conducted a limited launch at 11 clinical centers in the United States, with approximately 50 CTO procedures performed with Tigereye ST by 13 physicians.

These initial cases highlighted the successful implementation of the new design features into the platform, as well as an excellent safety profile, efficacy in crossing very challenging lesions, and exceptional product reliability. Tigereye ST features high definition, real-time intravascular imaging and a user-controlled deflectable tip designed to assist in steerability within the lumen. The device also includes an enhanced distal tip configuration with faster rotational speeds up to 1000 RPM designed to penetrate challenging lesions.

Capable of treating lesions in the peripheral vessels both above and below the knee, the Tigereye ST device has a working length of 140 cm and 5 French sheath compatibility. Tigereye ST is complementary to Avinger's best-in-class image-guided atherectomy devices, including the Pantheris, Pantheris LV, and Pantheris SV. Avinger's Lumivascular technology incorporates an onboard image-guidance system to allow physicians to see inside the artery during an atherectomy or CTO-crossing procedure by using an imaging modality called optical coherence tomography, or OCT.

During the procedure, high-resolution intravascular OCT images are displayed on Avinger's Lightbox console in real-time to guide therapy. Physicians performing therapeutic procedures with other devices must rely solely on X-ray images and tactile feedback to guide their interventions while treating complicated arterial disease. With the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions to deliver safe and effective outcomes, without exposing healthcare workers and patients to the negative effects of ionizing radiation.