In-stent restenosis treatment with OCT image-guided device receives CE Mark approval

The approval covers treating in-stent restenosis in peripheral artery disease patients with a lumivascular atherectomy system.

Oct 4th, 2017

Medical device developer Avinger (Redwood City, CA) has received European CE Mark approval for treating in-stent restenosis in peripheral artery disease (PAD) patients with the company's Pantheris Lumivascular atherectomy system.

Related: Avinger receives FDA approval for enhanced OCT image-guided atherectomy system

Lumivascular technology allows physicians to see from inside the artery during a directional atherectomy procedure by using an imaging modality called optical coherence tomography (OCT) that is displayed on the company's Lightbox console. With the Lumivascular approach using real-time OCT image guidance, physicians can more accurately navigate their devices to treat PAD without exposing healthcare workers and patients to the negative effects of ionizing radiation.

In-stent restenosis occurs when a previously blocked artery treated with a stent becomes narrowed again, blocking blood flow. Physicians often face challenges when treating in-stent restenosis both in terms of safety and efficacy. From a safety standpoint, limitations in imaging techniques such as x-ray fluoroscopy and the inability to control the directionality of other treatment modalities’ mechanism of action creates the concern of potentially impacting the integrity of the stent during the intervention. In terms of efficacy, current therapies for in-stent restenosis such as balloon angioplasty suffer from high rates of recurrent renarrowing within stents.

John B. Simpson, Ph.D., MD, Avinger's founder and executive chairman, explains that intravascular visualization, combined with a directional mechanism in real time, provides operators the information and precision needed to treat only diseased tissue without coming into contact with the stent struts or adventitia.

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