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Preparing for Full Commercial Launch in September
REDWOOD CITY, CA / ACCESSWIRE / August 29, 2019 / 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), today reported significant progress in the initial U.S. launch of the Pantheris SV (small vessel) image-guided atherectomy system. To date, physicians in 10 clinical centers have used Pantheris SV to successfully treat 50 patients in the U.S. Based on positive clinical reports and physician feedback from these initial sites, the Company is ramping production of Pantheris SV in preparation for full commercial launch, which is anticipated to begin in September.
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 smaller diameter vessels. The device features a longer 140 cm catheter length and a smaller six French (6F) profile. During these first cases, physicians used Pantheris SV to successfully treat lesions within a variety of treatment scenarios in all of the major arteries between the knee and ankle, including the tibial-peroneal trunk, the anterior tibial, the posterior tibial, and peroneal.
Two of the first operators in the nation to use Pantheris SV, Dr. Jon George and Dr. Sean Janzer, interventional cardiologists from Einstein Medical Center in Philadelphia, provided comments on their initial experiences with the device. “I have now had the opportunity to use Pantheris SV in five cases,” said Dr. George. “Not only does this technology provide the excellent safety and efficacy that I have come to expect from Pantheris, I have also been very pleased with the ease of use, image clarity, and ability to treat an expanded set of target lesions. We were even able to prevent a possible amputation for one particular patient by treating areas in the foot that previously would have been difficult without imaging.”
Dr. Janzer noted, “Pantheris SV represents a significant step forward in the treatment of below-the-knee disease, an area of significant unmet clinical need. Other technologies have limitations in either their safety or efficacy profiles for treating these more challenging vessels. Through the combination of onboard image-guidance with directional atherectomy for targeted plaque removal and maximal luminal gain, I believe Pantheris SV offers the potential to deliver excellent long-term clinical outcomes for these patients.”
“We are very pleased with how rapidly physicians in the initial U.S. sites completed their first 50 cases with Pantheris SV and are even more excited about the acute clinical outcomes and positive physician feedback reported from the sites,” commented Jeff Soinski, Avinger’s President and CEO. “Based on this clinical experience, we are moving quickly to launch the remainder of our initial U.S. sites and are preparing to begin full commercial launch in September.”
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, patient outcomes relating to Pantheris SV, our anticipated commercial launch and roll-out of Pantheris SV and other statements that are not historical facts. 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 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.
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SOURCE: Avinger, Inc.
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