Maverix Medical Announces FDA 510(k) Clearance for the Narwhal™ Cryo System

Console-free, single-use cryoprobe brings cryobiopsy to the bronchoscopy suite without dedicated capital equipment

The system comprises the Maverix Narwhal Cryoprobe and a single-use cryo cartridge, available separately or as a kit. The Maverix Narwhal Cryobiopsy Probe is indicated for palliative devitalization (destruction) of tissue during interventional procedures by the application of extreme cold and cryo-adhesion, for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies.

A console-free approach

Conventional flexible cryoprobes run off a dedicated cryosurgical console with an external compressed-gas cylinder and footswitch. The Maverix Narwhal Cryoprobe is instead powered by a single-use nitrous oxide (N₂O) cartridge activated by an integrated handle, eliminating the requirement to purchase or service a console.

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