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|Avinger Announces FDA Clearance and U.S. Launch of Breakthrough Treatment for Patients With Peripheral Artery Disease|
“I am excited and eager to commercially launch the most recent version of Pantheris. I offer a special thanks to all the patients and investigators who have made this possible,” said
Peripheral artery disease affects nearly 20 million adults in the U.S.1 and over 200 million people globally.2 PAD is caused by a build-up of plaque in the arteries that blocks blood flow to the legs and feet. Often dismissed as normal signs of aging, symptoms of PAD include painful cramping, numbness, or discoloration in the legs or feet. PAD can become so severe and difficult to address with traditional treatments that patients and physicians often resort to invasive bypass surgeries, which can result in even greater health risks and lengthy, painful recoveries. In severe cases, patients often face amputation, the worst-case scenario associated with PAD.
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 utilized in the Pantheris system allows physicians, for the first time ever, to see from inside the artery during a directional atherectomy procedure by using an imaging modality called optical coherence tomography, or OCT. In the past, physicians have had to rely solely on X-ray as well as touch and feel to guide their tools while they try to treat complicated arterial disease. With the lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions, thanks to the OCT images they see from inside the artery.
“Atherectomy is a proven treatment that relieves pain and restores blood flow, and Pantheris has been eagerly anticipated in the clinical community because it is a leap forward in atherectomy technology compared to what we have had in the past,” said
Pantheris has demonstrated clinical effectiveness and an excellent safety profile. In the recently completed VISION study, 130 patients were treated with Pantheris and followed for a period of six months. The study achieved its primary safety and efficacy endpoints and showed a target lesion revascularization rate of just 8%, and not a single event of vessel perforation, clinically significant dissection or late aneurysm resulted from Pantheris.
“Commercialization of Pantheris is a tremendous milestone for Avinger, and the organization has demonstrated exceptional performance against the critical path milestones we established,” said
"Avinger," “Pantheris” and the Avinger logo are registered trademarks of
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 clinical utility, expectations for growth and timing for commercial launch of Pantheris. 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; ability to demonstrate the benefits of our lumivascular platform; the resource requirements related to Pantheris; the outcome of clinical trial results including our VISION Trial; potential exposure to third-party product liability and intellectual property litigation; lack of long-term data demonstrating the safety and efficacy of our lumivascular platform products; 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” in our Form 10-Q filing made with the
2 Fowkes FG, Rudan D, Rudan I, et al. “Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis.” Lancet 2013; 382:1329.