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REDWOOD, CA / ACCESSWIRE / February 4, 2020 / Avinger, Inc. (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), announced today that its Pantheris atherectomy system was featured in a live case transmission at the Leipzig Interventional Course (LINC) 2020, a leading global forum for new methods in the field of vascular medicine held from January 28 through January 31 in Leipzig, Germany. In addition to performing the live case, Dr. Arne Schwindt, a key opinion leader in the field of vascular surgery, highlighted Avinger's Pantheris technology in a podium presentation at LINC entitled "Optimizing the SFA in CLIA."
Dr. Arne Schwindt and Dr. Angeliki Argyriou, vascular surgeons from St. Franziskus Hospital in Münster, Germany, performed the live endovascular procedure using Pantheris during a session entitled, "OCT-guided atherectomy of popliteal stent ISR followed by DCB." The patient for the live case presented with claudication and rest pain in the right leg, stemming from blockages within stents placed in a popliteal vein graft. The physicians successfully revascularized the area of the leg behind the knee, using Pantheris to remove blockages in a previously deployed stent, a condition known as in-stent restenosis or ISR. The debulking treatment was followed by the use of a drug-coated balloon, without the placement of any additional stents. Pantheris has CE-Marking for expanded labeling in Europe that includes a specific indication for the treatment of in-stent restenosis (ISR). Pantheris labeling in the United States does not include a specific ISR indication at this time.
Commenting on the case, Dr. Schwindt noted, "Traditional therapies, including standalone balloon angioplasty, have exhibited limited effectiveness for treating ISR and have high rates of recurrent blockages. Due to shortcomings in fluoroscopic image-guidance and the mechanical design of many atherectomy devices, the risk of a negative interaction with a stent structure also presents a safety concern for ISR patients. With Pantheris, the combination of targeted plaque excision and onboard intravascular guidance that very clearly delineates stent struts allowed me to safely and effectively treat this patient, and I was very pleased with the final result. I want to thank LINC and its organizers for giving me the opportunity to demonstrate this technology at this important platform, as I believe it represents a significant advance in treating a challenging patient cohort."
Jeff Soinski, Avinger's President and Chief Executive Officer, stated, "We are thrilled about the outcome for this patient and the opportunity for Dr. Schwindt to showcase the positive impact of our image-guided technology at this prestigious forum. We are continuing to build the clinical body of evidence to support the safety and efficacy of Pantheris in treating challenging lesions, such as ISR. We expect to complete enrollment and release clinical data later this year from our INSIGHT clinical trial, evaluating Pantheris for the treatment of in-stent restenosis. Following study completion, we anticipate filing a 510(k) submission with the U.S. FDA to pursue this claim. We believe a specific indication for ISR, which currently has very limited treatment options, would be an important growth driver for our business."
Atherectomy is a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel. Lumivascular technology allows physicians, for the first time ever, to see inside the artery during an atherectomy procedure by using an imaging modality called optical coherence tomography, or OCT, that is displayed on Avinger's proprietary Lightbox console. Physicians performing atherectomy with other devices must rely solely on X-ray images as well as 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 the 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-ever image-guided, catheter-based system that diagnoses and treats 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 imaging console, the Ocelot 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 our future performance, the impact of an in-stent restenosis indication for our addressable market, and outcomes of clinical trial results. 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; our ability to demonstrate the benefits of our Lumivascular platform; the resource requirements related to Pantheris; the outcome of clinical trial results; potential exposure to third-party product liability, intellectual property and other litigation; lack of long-term data demonstrating the safety and efficacy of our Lumivascular platform products; experiences of high-volume users of our products may lead to better patient outcomes than those of physicians that are less proficient; reliance on third-party vendors; dependency on physician adoption; reliance on key personnel; and requirements to obtain regulatory approval to commercialize our products; 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 6, 2019. 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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SOURCE: Avinger, Inc.
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