FDA clears Avinger's CTO catheter for PAD

Avinger has received FDA clearance to market its Wildcat catheter for crossing chronic total occlusions (CTOs) to help treat peripheral artery disease (PAD).

Redwood City, Calif.-based Avinger received CE mark for the Wildcat catheter in May. Wildcat's expanded indication is a result of the successful CONNECT trial, a prospective, multicenter, non-randomized, U.S. investigational device exemption study conducted at 15 centers which evaluated the safety and effectiveness of the Wildcat in crossing femoropopliteal CTO lesions, the company said in a statement.

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