Devices Interventional Regulatory

 News Release - May 12, 2011

Avinger Receives CE Mark Approval for Its Wildcat Catheter for the Treatment of Peripheral Artery Chronic Total Occlusions and Will Present Results from Its Connect Study at EuroPCR Conference May 17-19

CEO John B. Simpson, PhD, MD, Will Also Reveal Avinger’s Innovative Product Pipeline That Incorporates Real-Time Intravascular Imaging

REDWOOD CITY, Calif.--(Healthcare Sales & Marketing Network)-- Avinger, Inc. announced today that it has received CE Mark approval for Wildcat - an innovative, next-generation catheter used in endovascular procedures for the treatment of peripheral artery disease (PAD). In Europe, Wildcat is intended to create a channel in totally occluded peripheral vessels. The device may also be used to facilitate the placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions, or CTO) in the peripheral vasculature prior to further percutaneous intervention.

"The CE Mark approval for Wildcat is a huge step for Avinger and our dedication to helping the millions of afflicted PAD patients worldwide," said Avinger founder, CEO and renowned interventional cardiologist John B. Simpson PhD, MD. "With the rate of PAD in Europe closely rivaling the U.S., more and more patients are confronted with the threat of amputation and quality-of-life issues resulting from invasive bypass surgery. We are thrilled to be one step closer to our goal of empowering physicians everywhere with the most advanced tools and technologies to perform the least invasive procedures for PAD sufferers around the globe."

Avinger recently completed enrollment of the CONNECT (Chronic TOtal OcclusioN CrossiNg with thE WildCat CatheTer) study, an 88 patient IDE study evaluating Wildcat for crossing chronic total occlusions in femoropopliteal lesions, in support of a CTO indication. The CONNECT results will be presented at this year's EuroPCR Conference on May 17th at 12:00 pm by John Pigott, MD of JOBST Vascular Institute in Toledo, Ohio.

Avinger will have a significant presence at the EuroPCR conference held May 17-20, 2011 in Paris, France. Along with announcing the CONNECT results, Dr. Simpson will chair two sessions and also present Avinger’s innovative product pipeline that incorporates real-time intravascular imaging using Optical Coherence Tomography or OCT.

Avinger will begin commercialization of Wildcat in select European countries by the end of second quarter, 2011. Wildcat is commercially available as a guidewire support catheter in the United States.

ABOUT Avinger

Founded in 2007 by renowned cardiologist and medical device entrepreneur Dr. John B. Simpson, Avinger develops next-generation catheter-based technologies for the treatment of peripheral artery disease (PAD). Leveraging core competencies in medical device catheter engineering and intravascular imaging, Avinger markets Wildcat and Kittycat guidewire support catheters, and is currently developing advanced technologies that guide endovascular therapy and intervention using real-time imaging capability. www.Avinger.com.

Source: Avinger

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