Avinger (AVGR) Stock: Is This the Start of a Turnaround?

Avinger (NASDAQ:AVGR) bulls finally have something to smile about: The medical device maker announced this morning that it has received 510(k) clearance from the FDA for its next generation Pantheris® Lumivascular atherectomy system, the first-ever image-guided atherectomy device for the treatment of peripheral artery disease. Lumivascular is the only technology that combines real-time intravascular imaging with highly effective catheters for the treatment of PAD. Peripheral artery disease is projected to affect more than 21 million people in the United States alone by 2020.

Avinger shares reacted to the news, soaring nearly 60% to $2.05 as of 13:00PM EDT.

“We are excited to introduce the next generation Pantheris to our network of physicians here in the United States,” said Mr. Jeff Soinski, Avinger’s President and CEO. “After extensive testing by our R&D and operations teams, physician design validation, and successful initial case experience in Europe across a variety of different lesion types, we believe this next generation device will significantly improve the user experience in terms of reliability, efficiency, and ease of use across a spectrum of clinical situations.”

Dr. Barry Tedder, M.D., Interventional Cardiologist at St. Bernards Medical Center in Jonesboro, Arkansas, commented, “The Pantheris Lumivascular atherectomy system has allowed me to treat peripheral artery disease with more precision while largely avoiding trauma to the blood vessel during an intervention. Unlike some other products, this technology’s performance can stand on its own but also enhance other forms of adjunctive therapy if needed, while preserving future treatment options for the patient. As one of the first users of the initial generations of Pantheris, I have been eagerly awaiting the product enhancements incorporated into the new system, which has the promise of not only improving ease of use, but also providing a new level of operator control during the procedure.”

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.

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