FDA clears Ocelot catheter for PAD

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The FDA has cleared Avinger’s Ocelot System, an interventional chronic total occlusion crossing catheter, for sale in the U.S. The system is used to treat patients with peripheral artery disease (PAD).

The Ocelot catheter offers intravascular imaging technology through optical coherence tomography, which allows physicians to cross, see and navigate inside blocked arteries in legs of patients with PAD. The Ocelot catheter is supported by the Lightbox console.

According to Redwood City, Calif.-based Avinger, the FDA reviewed results from the Ocelot CONNECT II trial, which included 122 patients in the U.S.