REDWOOD CITY, CA / ACCESSWIRE / September 18, 2023 / 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 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.
Dr. Jaafer Golzar, an interventional cardiologist, Director of Endovascular Intervention at Advocate Christ Medical Center, and Avinger's Chief Medical Officer 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.'
Jeff Soinski, Avinger's President and CEO, 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.
About Avinger, Inc.
Avinger is a commercial-stage medical device company that designs and develops the first and only image-guided, catheter-based system for the diagnosis and treatment of patients with Peripheral Artery Disease (PAD). PAD is estimated to affect over 12 million people in the U.S. and over 200 million worldwide. Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox series of imaging consoles, the Ocelot and Tigereye® family of chronic total occlusion (CTO) catheters, and the Pantheris® family of atherectomy devices. Avinger is based in Redwood City, California. For more information, please visit www.avinger.com.
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the anticipated patient and physician benefits of our products, including Tigereye ST. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include the resource requirements related to our products; the timing and outcome of studies; as well as the other risks described in the section entitled 'Risk Factors' and elsewhere in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 16, 2023, as amended, and Quarterly Report on Form 10-Q. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Avinger disclaims any obligation to update these forward-looking statements.
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