REDWOOD CITY, CA / ACCESSWIRE / November 15, 2018 / Avinger, Inc. (NASDAQ: AVGR), 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), today announced the successful treatment of the first nine patients with Pantheris SV (Small Vessel) at two separate hospitals in Germany.
Dr. Arne Schwindt, a vascular surgeon at St. Franziskus Hospital Muenster and longtime innovator with Lumivascular technology, performed the first procedures globally.
Additional cases were performed by Dr. Ulrich Sunderdiek, an interventional radiologist and cardiac surgeon at Marienhospital Osnabrueck. Pantheris SV was used to successfully treat a variety of lesion types, including in-stent restenosis (ISR), calcified lesions, and a chronic total occlusion. In several cases, the Pantheris SV was used to treat multiple lesions in the same patient.
Designed with a lower profile and longer length, Pantheris SV is intended to expand the addressable market for Pantheris by allowing physicians to treat lesions in smaller diameter vessels (2 to 4 millimeters). Pantheris SV incorporates key improvements from the next generation Pantheris launched in the U.S. market in June 2018, including a stiffer shaft for increased pushability, a refined OCT imaging system, and an enhanced cutter design. Pantheris SV is available in limited supply for commercial sale in the EU; it is not available for sale in the US at this time.
Dr. Schwindt, the first physician ever to use Pantheris SV in patients, commented, ''Directional atherectomy combined with onboard image-guidance provides the confidence needed to treat small vessel disease, and an unmatched degree of precision and safety for this challenging anatomical area. We now have a device with the length and crossing profile to address lesions in smaller vessels, which will allow this technology to make a substantial difference in the treatment of arterial disease.''
Dr. Jaafer Golzar, Avinger's Chief Medical Officer who attended all of the cases, noted, ''We witnessed the beginning of a new generation of OCT-guided therapeutic catheters that produced exceptional intravascular imaging without the use of an occlusive balloon. Given the heightened importance of avoiding adverse events in small vessel disease, the unparalleled safety and precision in this first set of cases should make this a valuable tool for physicians performing these often difficult procedures.''
''We appreciate Dr. Schwindt's continued leadership in the use of Lumivascular technology and were excited to observe the positive results achieved with Pantheris SV in these initial cases,'' said Himanshu Patel, Avinger's co-founder and Chief Technology Officer. ''The encouraging physician feedback and patient outcomes validate our high expectations for this device in a clinical setting and provide important learnings to apply towards a broader commercial launch.''
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 from 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 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, thanks 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 Avinger's the benefits of Pantheris SV, reduction in radiation exposure, data supporting the use of Pantheris, and increased clinical applicability of Pantheris technology. 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 quarterly report on Form 10-Q filed with the Securities and Exchange Commission on November 13, 2018. 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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