Avinger this week announced that it received FDA 510(k) clearance for a new clinical indication for its Pantheris image-guided atherectomy system.
The new indication allows the Redwood City, California–based company to market the device for in-stent restenosis (ISR) treatment 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,” president and CEO Jeff Soinski said in a news release. “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 visualize 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 FDA clearance, Avinger submitted data from its Insight trial that evaluated the safety and effectiveness of Pantheris for treating ISR in lower extremity arteries.
“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,” said Dr. Glen Schwartzberg, co-principal investigator on the Insight study. “This technology allows the operator to target only the blockage and maximize 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.”
Avinger’s Lumivascular technology allows physicians to see inside the artery during an atherectomy or CTO crossing procedure by using imaging modality that is displayed on the company’s Lightbox console.