FDA approves the Wildcat catheter for crossing chronic total occlusions


The Food and Drug Administration (FDA) has cleared the Wildcat catheter (Avinger) for crossing chronic total occlusions to help treat peripheral artery disease. This catheter 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 chronic total occlusions crossing rate of any chronic total occlusions study to date,” said John B Simpson, peripheral artery disease expert, Avinger founder and CEO.

Wildcat’s expanded indication is a result of the CONNECT (Chronic total occlusion with the wildcat catheter) trial, a prospective, multicentre, non-randomised, US IDE study conducted at 15 centres which evaluated the safety and effectiveness of the Wildcat in crossing femoropopliteal chronic total occlusion 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 chronic total occlusions that were not crossable with standard guidewire techniques while maintaining a 95.2% safety profile. Co-principal investigators for the trial were Tom Davis, St. John Hospital and Medical Center, Michigan, USA and M Laiq Raja, Providence Memorial Hospital, Texas, USA.

“We are very excited about the results from CONNECT,” Davis said. “Wildcat is a proven device for crossing chronic total occlusions and should be considered for every patient facing peripheral bypass or amputation.”

John Pigott, Vascular Institute, Ohio, USA, who presented initial results at the 2011 EuroPCR Conference said, “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 chronic total occlusion indication.”

The Wildcat catheter was CE marked in May 2011.