REDWOOD CITY, Calif., June 26, 2018 (GLOBE NEWSWIRE) -- Avinger, Inc. (Nasdaq:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced that several physicians have successfully treated over 40 patients in the US across 13 sites with the next-generation Pantheris image-guided atherectomy system for the treatment of peripheral artery disease (PAD). This positive initial case experience in the US adds to the impressive clinical results achieved in the first 30 cases completed in Germany earlier this year and provides a strong foundation for expanded market launch into all US accounts.
The next-generation Pantheris design includes a simplified single balloon system for cutter apposition and blood flow management, a stiffer shaft for increased pushability, a more robust nosecone with the option for more tissue storage capacity, and an enhanced cutter design. These primary feature improvements and other small advancements are intended to augment the performance and reliability of the device, and have thus far resulted in very positive acute outcomes across a variety of lesion types, including heavily calcified disease, chronic total occlusions, and in arteries above and below the knee.
Dr. Glen Schwartzberg, a vascular surgeon at Baton Rouge General, was the first physician in the United States to use both versions of the next-generation device, the Pantheris A400 standard nosecone and Pantheris A400X extended nosecone, in separate cases. Summarizing his initial experiences on the new Lumivascular platform, Dr. Schwartzberg commented, “I am very excited about the outcomes for patients that the next-generation Pantheris has helped me achieve in my initial 10 cases. Since the infancy of this technology, I have always thought onboard image-guided atherectomy represented the future of endovascular intervention for many types of disease because of its ability to target specific pathology as opposed to other atherectomy devices which indiscriminately engage both normal and abnormal tissue, potentially creating harm. While still early in our experience with the device, the new design features have already expanded the applicability of Pantheris to a wider variety of lesion types and I have observed a marked improvement in cutting efficiency and ease of use. I use Pantheris as my front-line therapy due to its safety profile with the reduction of radiation and contrast delivery to the patient and my firm belief that this approach will generate better long-term results for patients. The data from the VISION trial with the first-generation Pantheris demonstrated the longer-term efficacy and safety of this therapy, and the body of evidence should only grow from here.”
“We are very pleased to deliver an enhanced device that will help Dr. Schwartzberg, and other physicians like him, produce better outcomes for patients,” said Jeff Soinski, Avinger’s president and CEO. “Our first US cases confirm many of the design changes incorporated into the next-generation Pantheris have improved performance and durability of the technology. Gaining experience across multiple users in the United States, different physician specialties, and a variety of lesion characteristics further substantiates the results generated with the next-generation device in Europe over the past few months.”
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). 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, CA. 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 the launch of next generation products, the benefits of the next generation Pantheris, data supporting the use of Pantheris, reductions in radiation exposure, and increased clinical applicability of the 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 May 15, 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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