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January 12, 2022

US FDA grants 510(k) clearance for Avinger’s new Lightbox 3 console

The new Lightbox 3 imaging console presents a significant reduction in cost, weight and size.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Avinger’s new Lightbox 3 imaging console, according to a company announcement.

Avinger designs and develops an image-guided, catheter-based system to treat Peripheral Artery Disease (PAD) patients.

Compared to the existing platform, the new Lightbox 3 imaging console presents a significant reduction in cost, weight and size.

Advanced features have also been added, including a powerful computing platform, solid-state laser for high-definition optical coherence tomography (OCT) imaging and a redesigned software system with an efficient user interface.

The new platform is expected to reduce barriers to the development of new accounts as well as speed up the process of evaluation.

Avinger president and CEO Jeff Soinski said: “The Lightbox 3 is designed to accelerate new account acquisition, energise existing users and support new catheter capabilities in the future.

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“We believe the reduced cost and increased portability of this significantly smaller console will be a major factor in efficiently expanding our Lumivascular treatment to new high-volume PAD centres and streamline the adoption of our technology.”

The new console has a size and weight reduction of 90% compared to the previous generation, allowing efficient installation options, easy transportation and a simplified service strategy.

It also allows the new Lightbox 3 to fit in a carry-on suitcase.

In the first quarter of the year, Avinger plans to begin a limited launch of the new Lightbox 3 in the US.

The product will subsequently be expanded to full commercial availability.

Avinger chief medical officer Dr Jaafer Golzar said: “Avinger has made significant advances in developing its proprietary portfolio of image-guided catheters with the introduction of three new catheter platforms in the last three years.

“The new Lightbox 3 represents the next leap forward with the release of an advanced imaging console designed to improve the user experience and support increased utilisation of Avinger’s image-guided devices.”

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