REDWOOD CITY, CA / ACCESSWIRE / June 5, 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 the successful completion of the first clinical cases with the new Tigereye ST image-guided CTO crossing system.
Dr. Ian Cawich, an interventional cardiologist at Arkansas Heart Hospital, and Dr. Jaafer Golzar, an interventional cardiologist at Advocate Christ Medical Center and Avinger's Chief Medical Officer, performed the first cases with the new system. Since the initiation of limited launch in May, four physicians at 5 U.S. hospital sites have successfully used Tigereye ST to treat CTOs in 14 separate procedures across a variety of lesion types and locations both above and below the knee.
Following his initial experience with Tigereye ST, Dr. Cawich noted, "As a long-time user of Avinger's image-guided CTO crossing and atherectomy platforms, I firmly believe that onboard visualization during these interventions leads to better outcomes for patients. Tigereye ST combines real-time OCT imaging with a powerful crossing catheter to safely treat challenging lesions, while minimizing the use of radiation and contrast dye for these types of procedures."
Dr. Golzar added, "I successfully used Tigereye ST in both de novo and restenotic in-stent CTOs both above and below the knee. While still early in our experience, I am extremely encouraged with the potential power of this system, as it represents one of the most significant technological advancements Avinger has made."
Jeff Soinski, Avinger's President and CEO, commented, "These initial case experiences offer early validation for the improvements brought to the platform by Tigereye ST. Based on our early success with the device, we plan to expand the limited launch to several additional sites in June and anticipate progressing to full commercial availability in the third quarter. We are excited about the results physicians are delivering for their patients in these first cases and the potential for Tigereye ST to be a significant growth driver for our image-guided CTO crossing portfolio."
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. 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's proprietary Lumivascular technology allows physicians to see from inside the artery during an atherectomy or CTO crossing procedure by using an imaging modality called optical coherence tomography, or OCT, that is displayed on Avinger's Lightbox console. Physicians performing atherectomy or crossing CTOs with other devices must rely solely on X-ray 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, due to real-time OCT images generated from inside the artery, 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 our planned launch of Tigereye ST, patient and physician benefits of Tigereye ST, expected growth resulting from the launch and physician adoption of Tigereye ST, and the timing of commercial availability of 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 product launch; 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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