Avinger’s Pantheris System Receives Clearance for Indication to Treat In-Stent Restenosis in Lower Extremity PAD

November 17, 2021—Avinger, Inc. announced that it has received FDA 510(k) clearance for a new clinical indication for the catheter-based Pantheris image-guided atherectomy system directly market the device for the treatment of in-stent restenosis (ISR) in lower extremity peripheral artery disease (PAD).

According to Avinger, the 510(k) submission was supported by data generated from the INSIGHT trial. INSIGHT was a prospective, global, single-arm, multicenter study to evaluate the safety and effectiveness of Pantheris for treating ISR in lower extremity PAD.

The study was led by coprincipal investigators Sean Janzer, MD, an interventional cardiologist, and Glen Schwartzberg, MD, a vascular surgeon. The clinical data from INSIGHT were presented by Jon George, MD, during a late-breaking clinical trials session at VIVA 2021, the annual Vascular InterVentional Advances meeting held October 4-7 in Las Vegas, Nevada. The data are also scheduled for presentation by Todd Vogel, MD, at the VEITHsymposium held November 16-20 in Orlando, Florida.

“The Pantheris system’s combination of onboard image-guidance and a directional excision mechanism provides significant clinical advantages in treating ISR not available with any other therapy,” commented Dr. Schwartzberg in Avinger’s press release. “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.”

Dr. Schwartzberg continued, “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.”