A commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of vascular disease, Avinger, Inc., has 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.
An interventional cardiologist, Director of Endovascular Intervention at Advocate Christ Medical Center, and Avinger’s Chief Medical Officer Dr. Jaafer Golzar commented on his clinical experience after using Tigereye ST, “This device represents one of the most significant advancements in Avinger’s image-guided technologies for the treatment of peripheral artery disease. Tigereye ST incorporates a robust new distal tip design to cross longer and more complex lesions and device features to make image interpretation easier, building on the enhanced imaging, higher rotational speeds, and precise user-control of the Tigereye platform. The unique combination of onboard image-guidance, steerability, ease of use, and crossing power expands the number of patients eligible for minimally invasive revascularization.”
Avinger’s President and CEO, Jeff Soinski noted, “Our limited launch experience validates the important design improvements we have incorporated into the Tigereye ST platform and our decision to expand into full commercial availability across the United States. Over the past several years, we have built a comprehensive portfolio of image-guided technology to enhance the efficacy and safety of peripheral vascular interventions, expand addressable procedures and increase the accessibility of our devices to more physicians and hospitals. We believe our newest imaging console – the Lightbox 3 – launched last year, Tigereye ST, and Pantheris LV – currently in limited launch – represent the most advanced interventional tools available for the treatment of peripheral vascular disease and are key components of this strategy.”
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.