Avinger out of Redwood City, California won FDA clearance for its Wildcat catheter, a device used for unblocking chronic total occlusions in patients with peripheral artery disease.
The new indication for the catheter allows surgeons to use the Wildcat to create a narrow channel within the blockage into which another device, like a balloon catheter or stent, can be inserted for further treatment.
From the press release:
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.
Product page: Wildcat …
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