Avinger Announces Successful Treatment of 1,000th Patient with Next-Generation Pantheris Device
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 patients with Peripheral Artery Disease (PAD), today announced that physicians in 78 clinical sites have successfully treated more than 1,000 patients with the next-generation Pantheris image-guided atherectomy system.
The next-generation Pantheris was launched on a limited basis in the U.S. following receipt of 510(k) clearance by the U.S. Food and Drug Administration (FDA) in late May 2018 and features a number of improvements intended to augment the performance and reliability of the product. Importantly, clinical results have remained consistently positive in a variety of lesion types since market launch. Initial market uptake, acute clinical outcomes, and positive physician feedback validate that the design enhancements have driven adoption of the next-generation device, as shown by a 52% year-over-year increase in Pantheris sales in the first three full quarters following launch, beginning July 1, 2018.
Dr. Dwight Dishmon, a highly experienced interventional cardiologist at Methodist South Hospital in Memphis, Tennessee and early user of Pantheris, commented, "Onboard image-guidance coupled with a directional atherectomy system allows for the creation of large channels to restore blood flow without causing vascular injury, which is important for both acute and long-term patient outcomes. In my experience, the next-generation Pantheris platform provides a heightened level of cutting efficiency, precision, and ease of use, making it an extremely valuable tool in the fight against PAD."
"With more than 1,000 patients now treated with the next-generation Pantheris, we continue to hear very positive feedback from our physician users, validating the rigorous design and development process that we undertook to enhance the Pantheris platform," said Jeff Soinski, Avinger's President and CEO. "The new and optimized product features have translated into increased market adoption and strong Pantheris revenue growth since launch of the next-generation device. Many of the same design improvements were incorporated into the Pantheris SV (Small Vessel) product that we plan to launch in the third quarter of this year."
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 the next-generation Pantheris, 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 May 8, 2019. 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.