Avinger Releases Wildcat Chronic Total Occlusion Crossing Results from the CONNECT Trial at EuroPCR Conference

Avinger, Inc. released initial data from the CONNECT Study today at the EuroPCR Conference in Paris. The study evaluated the safety and efficacy of the Wildcat Catheter in crossing chronic total occlusions (CTOs) in femoropopliteal lesions, the leading cause of amputation for patients suffering from peripheral artery disease (PAD).

The CONNECT Study (Chronic TOtal OcclusioN CrossiNg with thE WildCat CatheTer) was a prospective, multi-center, non-randomized, U.S. IDE study conducted at 15 centers to support an expanded indication for crossing CTOs for Avinger’s commercially available Wildcat Catheter. Results showed both the primary safety and efficacy endpoints were achieved demonstrating a 95.2% safety profile and an 89.3% successful crossing rate. Secondary endpoints of Device, Lesion and Procedural success were also very high at 89.3%, 89.8% and 89.3%, respectively.

The primary safety endpoint was a composite endpoint of freedom of in-hospital or 30-day major adverse events, and clinically significant perforations, clinically significant embolizations, Grade C or greater dissections confirmed by independent angiographic review. The primary efficacy endpoint was successful femoropopliteal CTO crossing using Wildcat identified by guidewire placement in the distal true lumen confirmed by independent angiographic review. Patients were followed for 30 days post procedure. Co-Principal investigators for the trial were Dr. Thomas Davis of St. John Hospital and Medical Center in Detroit, Michigan and Dr. Laiq Raja of Providence Memorial Hospital in El Paso, Texas. The data were presented by John Pigott, MD of Jobst Vascular Institute in Toledo, Ohio to attendees at the EuroPCR cardiovascular conference.

“Crossing CTOs is the critical first step in helping physicians successfully treat patients with PAD who might otherwise require surgical bypass or amputation,” said Avinger founder, CEO and renowned interventional cardiologist John B. Simpson, PhD, MD. “These are really promising results that illustrate the ability of Wildcat to cross CTOs and save patients’ legs.”

The data presented come off the heels of the Avinger’s announcement that it has received CE Mark approval for Wildcat in Europe and will begin commercialization in select European countries by the end of second quarter, 2011. Wildcat is currently commercially available as a guidewire support catheter in the U.S. A U.S. premarket notification for a CTO indication is pending FDA review.

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 .

Contact:

Avinger
J.D. Simpson, +1-650-363-2400
Vice President, Commercial Operations
Jd[at]avinger.com
or
Mortar PR
Serene Buckley, +1-415-772-9907 x117 (Press)
Serene[at]mortarpr.com