Maverix Medical has received US Food and Drug Administration (FDA) 510(k) clearance for its Maverix Narwhal™ Cryo System, a single-use flexible cryoprobe designed for interventional lung procedures.
The Narwhal system combines a flexible cryoprobe with a disposable nitrous oxide (N₂O) cartridge, eliminating the need for a dedicated cryosurgical console, external gas cylinder and footswitch.
This design is intended to simplify clinical workflows and reduce equipment requirements for bronchoscopic procedures.
The cryoprobe is indicated for palliative tissue devitalisation using extreme cold and cryo-adhesion.
Potential applications include tissue biopsy, removal of foreign bodies, mucus plugs, blood clots, necrotic tissue and tumours, as well as palliative recanalisation.
The system offers approximately 160 seconds of total freeze endurance per probe and around 80 seconds per disposable N₂O cartridge.
An adjustable sheath provides approximately 3 mm or 6 mm of exposed cryotip length.
Its 1.3 mm shaft and 115 cm working length are designed for bronchoscopes and endoscopes with working channels of at least 2.0 mm.
Maverix expects US availability in 2027 through Thoracent.
The company said the clearance could support wider adoption of bronchoscopic cryobiopsy by providing a more accessible, console-free approach.
