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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 that physicians in four U.S. sites have successfully treated several patients with the Pantheris SV (Small Vessel) image-guided atherectomy system. These initial cases are part of a limited launch at up to 13 leading clinical centers prior to expanding commercial distribution to additional treatment facilities in the U.S.
Pantheris SV, a product line extension of Avinger’s onboard image-guided atherectomy platform, expands Avinger’s portfolio of atherectomy devices for the treatment of PAD and increases the number of addressable procedures for the Company’s Lumivascular technology by allowing physicians to target more distal regions of the vasculature in small diameter vessels. The device features a 140 cm catheter length and a smaller six French (6F) profile, and incorporates key improvements introduced to the platform with the next generation Pantheris catheter in May 2018. Pantheris SV received CE Marking in October 2018 and the first several patients were treated with the device in Germany since that time. The Company has incorporated additional design improvements into the U.S. limited launch version of the technology, which is anticipated to be introduced into the European market later this year.
Dr. Edward Pavillard, a vascular surgeon at PA Vascular Institute in King of Prussia, Pennsylvania performed the first Pantheris SV case in the United States. As part of his practice, Dr. Pavillard treats a high volume of patients with small vessel peripheral artery disease, which often involve very complicated interventions. Commenting on his first case, Dr. Pavillard noted, “Pantheris SV’s onboard image-guidance highlighted the eccentric nature of the disease and allowed me to target just the removal of the plaque, while leaving minimal residual stenosis without adjunctive therapy. This technology is the only atherectomy device that I would feel safe using in this type of disease, and having a live image was key to the success of the procedure. The patient had brisk blood flow post-intervention, zero complications in a critical area of the vasculature, and the whole procedure was completed without the use of contrast and with minimal fluoroscopy time.”
“The positive outcomes that interventionalists were able to achieve in these initial cases using Pantheris SV highlight the potential for this technology,” commented Jeff Soinski, Avinger’s President and CEO. “With fewer durable treatment options for small vessel disease available to physicians, we believe that Pantheris SV addresses an unmet clinical need by offering a unique combination of luminal gain and safety. We continue to see positive momentum with our image-guided atherectomy platform and believe that Pantheris SV could increase our available market for these procedures by as much as 50%, while driving adoption through our current commercial infrastructure and customer base.”
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.
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Safe Harbor DisclosureThis press release contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements include, but are not limited to, statements related to the Company's launch of design improvements to Pantheris SV, the introduction of such improvements into the European market, the patient outcomes relating to Pantheris SV, the available market for procedures using Pantheris SV and other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that may cause actual results or events to differ materially from those projected. These risks and uncertainties, many of which are beyond our control, include: risks relating to Pantheris SV’s effectiveness; patient outcomes relating to Pantheris SV; our ability to increase the available market for procedures using Pantheris SV; risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of development activities; our ability to attract, integrate and retain key personnel; our need for substantial additional funds; patent and intellectual property matters; competition; as well as other risks described in the section entitled “Risk Factors” and elsewhere in our Annual Report on Form 10-K filed with the SEC on March 6, 2019 and in our other filings with the SEC, including, without limitation, our reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.