FDA Clears Avinger's Wildcat Catheter for CTO Treatment

August 16, 2011—Avinger, Inc. (Redwood City, CA) has received 510(k) clearance from the US Food and Drug Administration to market its Wildcat catheter for crossing chronic total occlusions (CTOs) to allow treatment via balloon angioplasty, stent, or atherectomy for peripheral artery disease. Avinger received CE Mark approval for the Wildcat catheter in May 2011.

According to the company, the expanded indication is based on results from the CONNECT trial, a prospective, multicenter, nonrandomized study conducted at 15 centers in the United States under an investigational device exemption. CONNECT evaluated the safety and effectiveness of the Wildcat in crossing femoropopliteal CTO lesions. 

The CONNECT study included 88 patients with a mean age of 69.5 years, and 53.4% were men. The study results demonstrated the efficacy of the Wildcat, which was able to cross 89.3% of CTOs that were not crossable with standard guidewire techniques while maintaining a 95.2% safety profile. Tom Davis, MD, and M. Laiq Raja, MD, served as CONNECT's Coprincipal Investigators. John Pigott, MD, presented the initial CONNECT results on May 17, 2011, at the EuroPCR conference in Paris.

Dr. Pigott stated, “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.”