New device enables doctors to see inside arteries

Avinger’s medical device, which allows doctors see inside arteries and remove dangerous plaque, has been given US Food and Drug Administration (FDA) approval

Avinger, a developer of treatments for peripheral artery disease (PAD), has received 510(k) clearance from the FDA for an enhanced version of its Pantheris lumivascular atherectomy system, the first-ever image-guided atherectomy device for the treatment of PAD.

The company said it will now begin US commercialisation of the enhanced Pantheris, which features improved ergonomics, physician controls and manufacturability.

John Simpson, the company’s founder and executive chairman, said: “I am excited and eager to commercially launch the most recent version of Pantheris.

“Our goal has always been to bring to market the most advanced technology for physicians and their patients affected by PAD. With that in mind, we have used the past several months to integrate physician feedback to further improve Pantheris.

“We are excited to introduce the system to patients and physicians, fulfilling our mission to radically change the treatment of vascular disease.”

PAD is caused by a build-up of plaque in the arteries that blocks blood flow to the legs and feet. In severe cases, patients often face amputation, the worst-case scenario associated with PAD.

Atherectomy is a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel.

Lumivascular technology used in the Pantheris system allows physicians to see from inside the artery during a directional atherectomy procedure by using an imaging modality called optical coherence tomography, or OCT.

In the past, physicians have had to rely solely on X-ray as well as touch and feel to guide their tools while they try to treat complicated arterial disease.

With the lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions, thanks to the OCT images they see from inside the artery, according to Avinger.

Thomas Davis, St. John Hospital and Medical Center in St. Clair Shores, Michigan, said: “Now, for the first time, we are able to see exactly where we are removing the plaque and are better able to leave the healthy artery alone.

“Pantheris visualises the artery without requiring ionizing radiation. Thus, OCT has the potential to reduce physician and patient X-ray exposure, which is a concern for all clinicians performing multiple procedures.”

In the recently completed VISION study, 130 patients were treated with Pantheris and followed for a period of six months. The study achieved its primary safety and efficacy endpoints and showed a target lesion revascularisation rate of just 8%, and not a single event of vessel perforation, clinically significant dissection or late aneurysm resulted from Pantheris.

In October 2015, Avinger received 510(k) clearance from the FDA for the Pantheris system for the treatment of patients with PAD.

The company subsequently filed a second 510(k) application in December 2015 seeking clearance for an enhanced version of the system, including improved ergonomics, physician controls and manufacturability.