FDA clears Avinger's CTO catheter for PAD

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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.