A 510(k) clearance has been won by Maverix Medical for the Narwhal Pro Cryo System, the second of two flexible lung cryoprobes that share a cartridge-powered architecture. September 2 was the date the FDA cleared the device, and the company announced it this week.
Running on a single-use nitrous oxide cartridge, the Pro works like the original Narwhal Cryoprobe that was cleared in June. Disposable as a whole system, it removes any need to buy or service a cryosurgical console, which is a meaningful cost for hospitals that use cryobiopsy only occasionally.
## Built for the scopes physicians already own
Tuned for bronchoscopes of 600 mm or shorter is the Pro’s working length, and adapters for Olympus, Fuji and Pentax scopes are included. How far the sheath extends and where the probe sits can be set precisely by the physician using sheath and probe advancement controls. Working channels of 2 mm or larger are compatible with it.
Palliative devitalization of tissue through extreme cold is the device’s indication, used for removing foreign bodies, mucus plugs, blood clots and necrotic tissue, for palliative recanalization, and for biopsies.
Against forceps transbronchial biopsy, a 1.1 mm cryoprobe lifted diagnostic yield by 10%, according to the FROSTBITE-2 study in JAMA that Maverix cites.
