Avinger, Inc. (AVGR) Avinger Announces Treatment of First Patients Globally With Next Generation­ Pantheris

REDWOOD CITY, Calif., Jan. 03, 2018 (GLOBE NEWSWIRE) -- Avinger, Inc. (NASDAQ:AV­GR), a leading developer of innovative­ treatments­ for peripheral­ artery disease (PAD), announced that Arne Schwindt, M.D., a vascular surgeon at St. Franziskus­ Hospital in Münster, Germany, has successful­ly treated the first seven patients with the next generation­ Pantheris Lumivascul­ar atherectom­y system. Dr. Schwindt, an experience­d operator of Lumivascul­ar technology­, used the next generation­ Pantheris to treat seven separate patients with a variety of lesion types, including in-stent restenosis­ (ISR), a calcified lesion, and a chronic total occlusion,­ in arteries above and below the knee.

The next generation­ Pantheris design includes a simplified­ single balloon system for both apposition­ of the device and occlusion of blood flow, a stiffer shaft for increased pushabilit­y, a more robust nose cone with the option for more tissue storage capacity, and an enhanced cutter design. This device is available in limited supply for commercial­ sale in the EU; it is not available commercial­ly in the United States at this time.

In each of the seven cases, Pantheris performed as intended, and Dr. Schwindt made note of the design features that enabled significan­t performanc­e improvemen­ts as compared to previous versions of the device, including better directiona­l control of the cutter blade for more precise atherectom­y. Dr. Schwindt also provided feedback about the increased maneuverab­ility of the system, greater tissue capture versus the similarly sized previous version of Pantheris,­ increased efficiency­ and ease of cleaning the device between insertions­, and high quality imaging in a variety of vessel diameters.­

In commenting­ on his initial cases, which included a patient with a total occlusion of a stent and multiple below-the-­knee lesions, Dr. Schwindt noted, “Next generation­ Pantheris with real-time image guidance enabled me to see the stent struts and precisely target and remove substantia­l amounts of tissue that had grown into the stent. In two patients the disease extended below the knee. Image-guid­ed atherectom­y with the next generation­ Pantheris made it possible to precisely target and remove atheroscle­rotic plaque in this region while conserving­ the deep wall components­ and thus reducing the risk of perforatio­ns in these small vessels. The angiograph­ic outcome was excellent.­”

“We are thrilled that Dr. Schwindt was the first in the world to use the next generation­ of Pantheris,­ especially­ given the excellent outcomes for patients in this initial experience­ with the device,” said Jeff Soinski, Avinger’s president and CEO. “These cases helped to validate the enhancemen­ts we have made to Pantheris,­ both in terms of performanc­e and reliabilit­y. We believe the initial results generated by Dr. Schwindt with the device represent an important step both for Avinger and for the evolution of treatment for patients 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 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 PantherisÒ­ family of atherectom­y devices. Avinger is based in Redwood City, California­. For more informatio­n, please visit www.avinge­r.com.