REDWOOD CITY, CA / ACCESSWIRE / October 18, 2018 / Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced Conformité Européenne (CE) Marking approval of Pantheris SV (Small Vessel), a product line extension of the Lumivascular atherectomy system. CE Marking allows for distribution of Pantheris SV in the European Union (EU) and certain other countries that recognize the CE Marking. Pantheris SV is not available commercially in the United States at this time.
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) and more distal regions of the vasculature. 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.
”We believe that Pantheris SV represents a substantial market expansion opportunity for our technology, and having CE Marking for the device represents an important first step towards broader commercialization,” commented Jeff Soinski, Avinger’ President and CEO. ”The longer length and smaller profile of this new device should increase the number of lesions available for treatment by Pantheris, and we believe the safety profile enabled by our image-guidance system should enhance the confidence of physicians applying directional atherectomy to smaller vessels.”
Dr. Jaafer Golzar, Avinger’ Chief Medical Officer, noted, ”Pantheris SV represents an important new option for physicians to treat small vessel disease. Given the potential consequences of an adverse event during peripheral interventions in this challenging area of the vasculature, a device with a high safety profile is of paramount importance. With real-time OCT visualization, we believe physicians will have the information they need to safely perform an intervention while maximizing the size of the channel restoring blood flow to the extremities, which should lead to better outcomes for patients with small vessel disease. We are excited to initiate our first clinical experiences with Pantheris SV in Europe in the near future.”
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’ 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.
Forward-Looking Statements
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 the benefits of Pantheris SV, data supporting the use of Pantheris, and increased clinical applicability and physician adoption 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 August 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.
Public Relations Contact:
Phil Preuss
VP of Marketing & Business Operations
Avinger, Inc.
(650) 241-7942
Investor Contact:
Mark Weinswig
Chief Financial Officer
Avinger, Inc.
(650) 241-7916
SOURCE:Avinger Inc.
