Avinger Announces Filing of 510(k) Submission for Tigereye ST Image-Guided CTO Crossing System

Rhea-AI Summary

Avinger, Inc. (NASDAQ:AVGR) announced the submission of a 510(k) application to the FDA for its Tigereye ST catheter, an advanced system for treating Peripheral Artery Disease (PAD). This next-gen catheter features an innovative design that enhances crossing capabilities across chronic total occlusions (CTOs). With a working length of 140 cm, the device is compatible with 5 French sheaths, aiming to improve patient outcomes. CEO Jeff Soinski highlights that this device could significantly boost growth, building on a 47% increase the previous year in their CTO business.

Positive

• Submission of 510(k) application to FDA for Tigereye ST catheter enhances growth opportunity.
• Tigereye ST builds on successful previous device, potentially expanding market share.
• Advanced design features may improve crossing capabilities for physicians.

Negative

• None.

REDWOOD CITY, CA / ACCESSWIRE / July 6, 2022 / 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 Peripheral Artery Disease (PAD), today announced the company has submitted a 510(k) application to the U.S. Food & Drug Administration (FDA) for the Tigereye ST catheter, a next generation chronic total occlusion (CTO) crossing system utilizing Avinger's proprietary image-guided technology platform.

Tigereye ST is a next generation line extension of Avinger's Ocelot and Tigereye™ family of CTO crossing catheters. This new image-guided catheter has an integrated outer spinning tip that pairs with the rotation of the inner tip to penetrate challenging blockages and CTO caps. Tigereye ST incorporates an advanced shaft design for pushability and torque response and a three-marker system, similar to Ocelot's, to facilitate consistent image interpretation across the platform. Tigereye ST continues to provide the high definition, real-time intravascular imaging, user-controlled deflectable tip, and faster rotational speeds introduced to Avinger's CTO portfolio with the commercial launch of Tigereye in early 2021. The low-profile Tigereye ST has a working length of 140 cm and 5 French sheath compatibility to allow physicians to access CTOs throughout the peripheral vasculature, both above and below the knee.

"The 510(k) submission for Tigereye ST represents an important milestone for Avinger as we continue to bring new innovation to our platform to expand the utility and usage of our proprietary image-guided devices," commented Jeff Soinski, Avinger's President and CEO. "The commercial launch of the original Tigereye in January 2021 enabled us to grow our image-guided CTO business by 47% in 2021. With its unique combination of benefits, we believe that Tigereye ST has the potential to significantly expand upon this growth, and we are excited to launch this innovative new device into the U.S. market following FDA clearance."

Avinger's Chief Medical Officer, Dr. Jaafer Golzar, noted, "Avinger's Ocelot and Tigereye image-guided devices have allowed physicians to safely and effectively cross thousands of chronic total occlusions, one of the most significant technical challenges to physicians treating peripheral artery disease. Tigereye ST builds upon this legacy. Paired with our new Lightbox 3 imaging platform, I believe that Tigereye ST represents the most clinically relevant and technically advanced CTO-crossing system ever developed and look forward to incorporating this innovative new device into my clinical practice once it is available in the U.S."

Avinger's Lumivascular technology incorporates an onboard image-guidance system to allow physicians, for the first time ever, 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.

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Forward-Looking Statements

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 patient and physician benefits of the Tigereye ST image-guided CTO crossing system and potential FDA approval of our 510(k) application relating to the Tigereye ST image-guided CTO crossing system. 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 our dependency on a limited number of products; the resource requirements related to our products; the timing and outcome of clinical trial results; 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 22, 2022 and our Quarterly Report on Form 10-Q filed on May 10, 2022. 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.

Investor Contact:
Matt Kreps
Darrow Associates Investor Relations
(214) 597-8200
mkreps@darrowir.com

Public Relations Contact:
Phil Preuss
Chief Marketing Officer
Avinger, Inc.
(650) 241-7942
pr@avinger.com

SOURCE: Avinger, Inc.

View source version on accesswire.com:
https://www.accesswire.com/707482/Avinger-Announces-Filing-of-510k-Submission-for-Tigereye-ST-Image-Guided-CTO-Crossing-System

FAQ

What is the 510(k) application submitted by Avinger related to?

The 510(k) application is for the Tigereye ST catheter, an advanced system for treating Peripheral Artery Disease.

How does the Tigereye ST catheter differ from previous models?

It features an integrated outer spinning tip for better penetration of challenging blockages and an advanced shaft design.

What growth did Avinger experience in its CTO business in 2021?

Avinger saw a 47% growth in its CTO business in 2021 following the launch of the original Tigereye.

When did Avinger launch the original Tigereye catheter?

The original Tigereye catheter was commercially launched in January 2021.