Avinger recently announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for a new clinical indication for the Pantheris image-guided atherectomy system. This clearance allows the company to directly market Pantheris for the treatment of in-stent restenosis (ISR) in the lower extremity arteries.
“We are excited to receive FDA clearance for the ISR indication, which expands our addressable market for Pantheris to include a high-incidence disease state for which there are few available indicated treatment options,” commented Jeff Soinski, Avinger’s president and CEO. “Pantheris is now the only directional atherectomy device to have a clinical indication for the treatment of in-stent restenosis, providing a compelling new point of differentiation for the device. By combining real-time intravascular imaging with the precise control and large luminal gain of directional atherectomy, Pantheris enables physicians to visualise stent struts and safely target ISR lesions to restore blood flow to occluded vessels, while avoiding the structure of the previously implanted stent.”
To support the 510(k) submission with the FDA, Avinger provided data generated from the INSIGHT trial, a prospective, global, single-arm, multicentre study to evaluate the safety and effectiveness of Pantheris for treating in-stent restenosis in lower extremity arteries. Sean Janzer, an interventional cardiologist at Albert Einstein Medical Center in Philadelphia, USA, and Glen Schwartzberg, a vascular surgeon in Baton Rouge, USA, served as co-principal investigators of the study. The clinical data from INSIGHT was presented at Vascular Interventional Advances (VIVA) 2021 (5–7 October, Las Vegas, USA) by Jon George, an interventional cardiologist at University of Pennsylvania Health System in Philadelphia, USA, and were also presented at the 2021 VEITH Symposium (16–20 November, Orlando, USA) by Todd Vogel, chief of cardiovascular surgery at University of Missouri Health in Columbia, USA.
“The Pantheris system’s combination of onboard image guidance and a directional excision mechanism provides significant clinical advantages in treating in-stent restenosis not available with any other therapy,” noted Schwartzberg. “This technology allows the operator to target only the blockage and maximise the channel for restored blood flow while avoiding negative interactions with clearly delineated stent struts. Based on the results of the INSIGHT study and my personal experience with the device, I believe that Pantheris can help physicians safely and effectively treat many ISR patients that previously may not have had other options available and reduce the need for repeat interventions and more invasive surgeries.”
According to a press release, Avinger’s proprietary Lumivascular technology allows physicians, for the first time ever, to see from inside the artery during an atherectomy or chronic total occlusion (CTO) crossing procedure by using optical coherence tomography (OCT) that is displayed on Avinger’s Lightbox console.
Physicians performing atherectomy or crossing CTOs with other devices must rely solely on X-ray and tactile feedback to guide their interventions while treating complicated arterial disease. With the Lumivascular approach, the press release continues, physicians can more accurately navigate their devices and treat peripheral arterial disease (PAD) lesions, due to real-time OCT images generated from inside the artery, without exposing healthcare workers and patients to the negative effects of ionising radiation.