Tag: Avinger

Avinger announces 510(k) filing of Pantheris Small Vessel device

Avinger, a developer of treatments for peripheral artery disease (PAD), has announced the Company submitted a new 510(k) application to the US Food &...

Avinger’s next-generation Pantheris Lumivascular atherectomy system gets FDA clearance

Avinger has announced that the company received 510(k) clearance from the US Food & Drug Administration (FDA) for its next generation Pantheris Lumivascular atherectomy...

First patients treated with Avinger’s next generation atherectomy device

Avinger, a developer of treatments for peripheral artery disease (PAD), has announced the first use of their next generation Pantheris lumivascular atherectomy system. The...

First patient enrolled in IDE study of the Pantheris system for...

Avinger has announced initiation of INSIGHT, a prospective, global, single arm, multicentre study to evaluate the safety and effectiveness of the Pantheris Lumivascular Atherectomy...

Avinger announces positive two year data from pivotal VISION study of...

Avinger has announced positive two-year clinical data from the pivotal VISION study of the company’s Lumivascular technology. Twenty-four-month follow-up results from 89 patients were...

Avinger announces new FDA clearance for Lumivascular imaging console

Avinger has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Lightbox L250 imaging console. Avinger says that with this...

Avinger launches upgraded Lightbox imaging console

Avinger has announced the US launch of an enhanced version of the company’s Lightbox imaging console. The Lightbox provides a dual display of images...

Avinger granted expanded US FDA indications for Pantheris image-guided atherectomy device

Avinger has received expanded indications from the US Food and Drug Administration (FDA) recognising the Pantheris lumivascular atherectomy system as a technology that can be...