REDWOOD CITY, CA / ACCESSWIRE / April 28, 2023 / 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 presentation of clinical data from the INSIGHT study during the Charing Cross (CX) International Symposium in London, England. The CX Symposium is a leading vascular and endovascular education conference focused on education, innovation, and evidence. The INSIGHT trial was designed to evaluate the safety and effectiveness of Avinger's Pantheris image-guided atherectomy system for treating in-stent restenosis (ISR) in lower extremity arteries.
Dr. Arne Schwindt, a vascular surgeon and endovascular interventionist in one of Germany's leading endovascular centers at St. Franziskus Hospital in Münster, presented 6 and 12-month follow-up results in his presentation entitled "Treatment of In-stent Restenosis with an Atherectomy Catheter: Results from the INSIGHT Study." Data from the study supported the subsequent 510(k) clearance by the U.S. Food and Drug Administration (FDA) for an expanded in-stent restenosis indication for Pantheris.
Key outcomes presented from the trial include:
- 82% luminal gain (increase in channel for blood flow) following the procedure
- 93% freedom from target lesion restenosis at 6 months post-procedure
- 89% freedom from target lesion restenosis at 12 months post-procedure
- No amputations for the 6 or 12-month cohorts of patients
- 0.96 mean ankle-brachial index at 6 months from a baseline of 0.69 pre procedure
- 71% improvement in Rutherford Class (a measure of disease severity) at 6 months
Commenting on the data, Dr. Schwindt noted, "As one of the investigators in this study, I was very pleased to see the tremendous outcomes for patients that would otherwise have very few effective options to address their recurring problem of in-stent restenosis. The results from the INSIGHT trial support Pantheris as a front-line treatment option for ISR, with the best combination of efficacy and safety in this patient cohort as compared to any other statistically significant data set produced by alternative technologies. The durability of outcomes through 12-months represents a significant step forward for the treatment of in-stent restenosis.
"Given the results of previous ISR treatment, the patient's fate was often bypass surgery after failing stents and sadly too often amputation after failing bypass. The results of INSIGHT encourage us to stop this downward spiral at the beginning by facilitating the most durable treatment option for in-stent restenosis to date."
INSIGHT is a prospective, global, single-arm, multi-center trial conducted at 17 sites. The primary safety endpoint was freedom from major adverse events through 30-day follow-up and the primary and secondary effectiveness endpoints were the proportion of target lesions with a residual diameter stenosis less than 50% post-atherectomy, and freedom from TLR at 6 months, respectively. An independent core lab adjudicated all images and a clinical events committee assessed adverse events. While 30-day and 6-month endpoints support the expanded clinical indication, patients were followed out to 12-months to track longer term outcomes. Key data points and outcomes from INSIGHT as compared to EXCITE-ISR are shown in Table 1. EXCITE-ISR was a randomized controlled study comparing laser atherectomy plus percutaneous transluminal angioplasty (PTA) versus angioplasty alone for treatment of femoropopliteal in-stent restenosis.
Table 1: EXCITE-ISR and INSIGHT Data
Laser + PTA1
Pantheris + PTA
|Baseline mean stenosis||
|Mean stenosis post-procedure||
|Freedom from MAE* (6-month)||
|Freedom from amputation (6-month)||
|Freedom from TLR** (6-month)||
|Freedom from TLR (12-month)||<45%||
|Mean ABI*** pre-procedure||
|Mean ABI post-procedure (6-month)||
*MAE = major adverse event
**TLR = Target lesion revascularization
***ABI = ankle-brachial index
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.2 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, do not actually remove occlusive material and have high rates of recurrent renarrowing within stents.
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.
About Avinger, Inc.
Avinger is a commercial-stage medical device company that designs and develops the first and only image-guided, catheter-based system for the diagnosis and treatment of patients with Peripheral Artery Disease (PAD). PAD is estimated to affect over 12 million people in the U.S. and over 200 million worldwide. Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox series of imaging consoles, the Ocelot and Tigereye™ family of chronic total occlusion (CTO) catheters, and the Pantheris® family of atherectomy devices. Avinger is based in Redwood City, California. For more information, please visit www.avinger.com.
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding patient and physician benefits of our products, and physician adoption of our products. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include our dependency on a limited number of products; the resource requirements related to our products; the timing and outcome of clinical trial results; as well as the other risks described in the section entitled "Risk Factors" and elsewhere in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 16, 2023. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Avinger disclaims any obligation to update these forward-looking statements.
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1 Dippel et al. JACC: Cardiovascular Interventions 2015; 8(1): 92-101.
2 Lichtenberg MK, Carr JG, Golzar JA. Optical coherence tomography: guided therapy for peripheral artery disease. The Journal of Cardiovascular Surgery 2017; 58(4):518-527.
SOURCE: Avinger, Inc.
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