REDWOOD CITY, Calif.--(BUSINESS WIRE)--Please replace the release with the following corrected version due to revisions to the Avinger boilerplate.
The corrected release reads:
AVINGER RECEIVES FDA 510(K) CLEARANCE TO MARKET THE WILDCAT CATHETER FOR CROSSING CHRONIC TOTAL OCCLUSIONS IN PERIPHERAL ARTERY DISEASE
Avinger, Inc., has received FDA clearance to market its Wildcat catheter for crossing chronic total occlusions (CTOs) to help treat peripheral artery disease, or PAD. Avinger, a medical device company dedicated to the creation of breakthrough technologies to treat vascular disease, received CE Mark Approval for Wildcat Catheter in May 2011. Wildcat creates a small channel in totally blocked peripheral arteries enabling subsequent therapeutic treatment via balloon angioplasty, stent or atherectomy.
“Based on our review of published IDE data, the CONNECT results appear to represent the highest reported CTO crossing rate of any CTO study to date,” said Avinger founder, CEO, PAD expert and renowned interventional cardiologist John B. Simpson, PhD, MD. “I am extremely proud of our company and our CONNECT investigators. We expect to help a lot more people suffering from PAD with Wildcat’s expanded indication for crossing CTOs.”
Wildcat’s expanded indication is a result of the successful CONNECT trial, a prospective, multi-center, non-randomized, U.S. IDE study conducted at 15 centers which evaluated the safety and effectiveness of the Wildcat in crossing femoropopliteal CTO lesions. The study included 88 patients with a mean age of 69.5 years of which 53.4% were male. Results from CONNECT demonstrated that Wildcat was able to cross 89.3% (efficacy) of CTOs that were not crossable with standard guidewire techniques while maintaining a 95.2% safety profile. Co-Principal investigators for the trial were Dr. Tom Davis of St. John Hospital and Medical Center in Detroit, Michigan and Dr. M. Laiq Raja of Providence Memorial Hospital in El Paso, Texas.
“We are very excited about the results from CONNECT,” remarked Dr. Tom Davis. “Wildcat is a proven device for crossing chronic total occlusions and should be considered for every patient facing peripheral bypass or amputation.”
John Pigott, MD of JOBST Vascular Institute in Toledo, Ohio, who debuted initial results at the 2011 EuroPCR Conference remarked, “The results of the trial were highly successful, with a good safety profile and high crossing rate, even for the most difficult occlusions. We had every confidence Wildcat would gain CTO indication.”
The announcement of CTO clearance from the FDA comes on the cusp of PAD Awareness Month in September and an invigorating time for Avinger and Dr. Simpson, who will be rigorously educating and advocating for decreased amputation statistics for PAD sufferers. In addition, the company is close to revealing a game-changing product pipeline that incorporates real-time intravascular imaging using Optical Coherence Tomography or OCT.
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 catheters, and is currently developing advanced technologies that guide endovascular therapy and intervention using real-time imaging capability. www.avinger.com.