Technology | Atherectomy Devices | September 29, 2017

Avinger Receives CE Mark for In-Stent Restenosis Indication With Pantheris Image-Guided Atherectomy

Device designed to empower physicians to precisely treat peripheral artery disease with real-time optical coherence tomography imaging

Avinger Receives CE Mark for In-Stent Restenosis Indication With Pantheris Image-Guided Atherectomy

September 29, 2017 — Avinger Inc. recently announced Conformité Européenne (CE) Marking approval for treating in-stent restenosis with the Pantheris Lumivascular atherectomy system.

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. 

Atherectomy is a minimally invasive treatment for peripheral artery disease (PAD) in which a catheter-based device is used to remove plaque from a blood vessel. Lumivascular technology allows physicians — for the first time ever, according to Avinger — to see from inside the artery during a directional atherectomy procedure by using an intravascular imaging modality called optical coherence tomography (OCT) that is displayed on the Lightbox console. In the past, physicians have had to rely solely on X-ray as well as tactile feedback to guide their tools while treating complicated arterial disease. 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. 

For more information: www.avinger.com


Related Content

News | Atherectomy Devices

Medtronic recently announced results from two studies evaluating the utility of atherectomy for peripheral endovascular ...

Home November 08, 2024
Home
News | Atherectomy Devices

February 15, 2023 — Abbott and Cardiovascular Systems, Inc. (CSI), announced a definitive agreement for Abbott to ...

Home February 15, 2023
Home
News | Atherectomy Devices

July 28, 2022 — Northeast Scientific Inc., pioneers in reprocessing single use peripheral vascular catheters, announced ...

Home July 28, 2022
Home
News | Atherectomy Devices

March 9, 2022 — Medtronic is recalling (correcting) the TurboHawk Plus Directional Atherectomy System due to design ...

Home March 09, 2022
Home
News | Atherectomy Devices

January, 24, 2022 — Medtronic Inc. is recalling its HawkOne Directional Atherectomy System product due to the risk of ...

Home January 24, 2022
Home
News | Atherectomy Devices

January 10, 2022 — Cardiovascular Systems Inc. (CSI) is recalling the Wirion atherectomy embolic protection device ...

Home January 10, 2022
Home
News | Atherectomy Devices

July 20, 2020 – BD (Becton, Dickinson and Company) recently completed the acquisition of Straub Medical AG, a privately ...

Home July 20, 2020
Home
News | Atherectomy Devices

February 13, 2020 — The U.S. Food and Drug Administration (FDA) has issued its final guidance on "Peripheral Vascular ...

Home February 13, 2020
Home
News | Atherectomy Devices

November 7, 2019 — The REVEAL FDA investigational device exemption (IDE) trial confirmed a favorable safety and ...

Home November 11, 2019
Home
News | Atherectomy Devices

November 7, 2019 — There was no difference between drug-coated balloons (DCB) vs. plain old balloon angioplasty (POBA) ...

Home November 07, 2019
Home
Subscribe Now