Avinger has received the US Food and Drug Administration ( FDA) approval for its Wildcat catheter to treat peripheral artery disease (PAD).
The Wildcat cather creates a small channel in totally blocked peripheral arteries which enables therapeutic treatment via balloon angioplasty, stent or atherectomy.
The approval was based on a non-randomized, multi-center, prospective – Connect IDE trial which was designed to assess the safety and effectiveness of the Wildcat in crossing femoropopliteal chronic total occlusions (CTO) lesions.
The Results showed that Wildcat was able to cross 89.3% of CTOs that were not crossable with standard guidewire techniques while maintaining a 95.2% safety profile.
St John Hospital and Medical Center Co-Principal investigator Tom Davis said Wildcat is a proven device for crossing chronic total occlusions and should be considered for every patient facing peripheral bypass or amputation.
The Wildcat catheter also received CE mark approval in May 2011.