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

Avinger Pantheris
Avinger Pantheris

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 used for both therapeutic and diagnostic purposes.

According to a company release, Pantheris is the first and only image-guided atherectomy device to receive clearance for diagnostic imaging as well as for the simultaneous treatment of peripheral artery disease. This expanded indication clarifies that, in addition to treatment of peripheral artery disease, Pantheris may be used by physicians to identify the vessel lumen and wall structures such as intima, internal elastic lamina, media, external elastic lamina and stent struts, as well as vessel morphologies such as calcium, thrombus, fibroatheromas, and necrotic cores.

Lumivascular technology in the Pantheris catheter is intended to allow physicians to see from inside the artery during a directional atherectomy procedure by using an imaging modality called optical coherence tomography (OCT). With the Lumivascular approach, physicians can more accurately navigate their devices to treat peripheral arterial disease lesions using the guidance of OCT images generated from inside the artery, according to the release. By relying upon OCT images as an adjunct to fluoroscopy, exposure to ionising radiation may be reduced for healthcare workers and patients.

“The FDA clearance of Pantheris as a diagnostic tool reflects what we as clinicians have already seen first-hand in our practices: that Pantheris OCT images provide important clinical information during our procedures, allowing us to see complicated plaque characteristics in real time as we treat the vessel,” says Suhail Dohad, interventional cardiologist with Cedars Sinai Hospital, Los Angeles, USA. “With Pantheris, we can now reliably assess disease extent while simultaneously treating disease, allowing a greater level of accuracy and confidence.”