Pantheris Receives Regulatory Clearance and First Patients Treated Successfully with Pantheris in Australia
REDWOOD CITY, Calif., Dec. 06, 2018 (GLOBE NEWSWIRE) -- Avinger, Inc. (AVGR), 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), today announced the commercial launch of its Pantheris image-guided atherectomy system in Australia. Avinger recently completed an exclusive distribution agreement with Diverse Devices Pty Ltd. for the sales and marketing of Avinger’s proprietary Lumivascular products in Australia. In addition, the Company announced it has received notice from Australia’s Therapeutic Goods Administration (TGA) that the Pantheris image-guided atherectomy system has been included on the Australian Register of Therapeutic Goods, which permits distribution in Australia.
Following regulatory clearance, Dr. Vikram Puttaswamy, a pre-eminent vascular surgeon at North Shore Private Hospital in Sydney, performed the first cases with Pantheris in Australia. Additional cases were performed by Dr. Yew Toh Wong, a leading vascular surgeon at Flinders Medical Centre Adelaide. Pantheris was used to successfully treat lesions in 5 patients primarily in the superficial femoral artery and included a case with in-stent restenosis.
Dr. Puttaswamy, the first operator to use image-guided atherectomy in Australia noted, “Maximizing the channel for blood flow in revascularizing the vessel, while simultaneously minimizing vascular injury is the goal in treating patients with PAD. This new device provides another option for Australian clinicians when treating patients with this serious disease.”
“We are excited to expand into a new geographical market with our products and look forward to a mutually beneficial partnership with Diverse Devices, a distributor of innovative medical devices in the Australian market with a strong clinical presence in the vascular space,” commented Jeff Soinski, Avinger’s President and CEO. “We are thrilled with the positive results from the first cases performed by the first Lumivascular physicians in Australia and look forward to hearing about many more successful cases with this ground-breaking technology in Australia. Given the positive safety and efficacy profile of our Lumivascular products demonstrated in our clinical trials, coupled with the recent launch of the improved next generation Pantheris, we anticipate that our new partnership in Australia will allow us to make a positive impact on the treatment of vascular disease in an important new market.”
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 commercial prospects in a new market, potential product introductions, and reliance on a third party partner for distribution of Avinger products. 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 November 13, 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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