Benzinga | Jul 6, 2021 08:36AM EDT

Avinger Announces 510(k) Filing For New Pantheris In-Stent Restenosis Indication

Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the submission of a 510(k) application to the U.S. Food & Drug Administration (FDA) for a new Pantheris clinical indication for the treatment of in-stent restenosis (ISR) in the lower extremity arteries.

Highlighting the importance of this submission, Jeff Soinski, Avinger's President and CEO commented, "We are extremely pleased with this milestone and the initial clinical data generated from the INSIGHT trial that supports the 510(k) submission. The safe and effective treatment of in-stent restenosis is an important clinical benefit, which we believe will provide a highly differentiated competitive advantage for Avinger's atherectomy products. With the large number of stents deployed in the lower extremity arteries, and the propensity for recurrence over a 2-to-3-year timeframe, the sheer number of ISR procedures performed in the U.S. each year provides a significantly expanded market opportunity for Pantheris, if our 510(k) application for this additional clinical indication is approved."

With approximately 200,000 stents placed in the femoral and popliteal arteries annually, and 30% to 40% of these stents expected to develop in-stent restenosis within 3 years of implantation, the treatment of in-stent restenosis represents both a significant market and healthcare burden.1 In-stent restenosis occurs when a blocked artery previously treated with a stent becomes narrowed again, reducing blood flow. Physicians often face challenges when treating ISR both in terms of safety and efficacy. From a safety standpoint, limitations in imaging techniques, such as X-ray fluoroscopy, and the inability to control the directionality of other treatment modalities creates the concern of potentially impacting the integrity of the stent during the intervention. In terms of efficacy, current therapies for in-stent restenosis, such as balloon angioplasty, have high rates of recurrent renarrowing within stents.

To support the FDA submission for this new indication, Avinger provided data generated from the INSIGHT trial, a prospective, global, single arm, multi-center study to evaluate the safety and effectiveness of the Pantheris atherectomy system for treating in-stent restenosis in lower extremity arteries. Sean Janzer, M.D., an interventional cardiologist, and Glen Schwartzberg, M.D., a vascular surgeon, served as co-principal investigators of the study.

"The treatment of in-stent restenosis represents a significant clinical challenge for interventionalists, with very limited safe and effective options available," commented Dr. Schwartzberg. "Other technologies risk a potentially adverse interaction with the stent struts due to their lack of onboard image-guidance or mechanism of action, while others only compress the blockage against the stent and do not actually remove the occlusive tissue. The imaging system mounted on Pantheris combined with the directional excision mechanism allows the operator to target only the blockage and avoid the clearly delineated stent struts."

Dr. Janzer noted, "One of the primary goals with these patients is to avoid or prolong the need for repeat interventions, invasive surgeries, and amputations. The precision provided by Pantheris can help interventionalists achieve this objective and provide better outcomes for the complex condition of in-stent restenosis, both in terms of acute safety standpoint and longer-term efficacy."

Avinger's proprietary Lumivascular technology allows physicians, for the first time ever, to see from inside the artery during an atherectomy or CTO crossing procedure by using an imaging modality called optical coherence tomography, or 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, physicians can more accurately navigate their devices and treat PAD lesions, due to real-time OCT images generated from inside the artery, without exposing healthcare workers and patients to the negative effects of ionizing radiation.

1Lichtenberg MK, Carr JG, Golzar JA. "Optical coherence tomography: guided therapy for peripheral artery disease." The Journal of Cardiovascular Surgery. 04 April 2017, 58(4):518-527.