Menlo Park, California, United States, October 14, 2026
Maverix Medical has expanded its console-free cryotherapy portfolio with U.S. Food and Drug Administration (FDA) 510(k) clearance for the Narwhal™ Pro Cryo System, a flexible cryoprobe designed to support bronchoscopic procedures used in lung disease diagnosis and treatment. The FDA granted clearance on September 2, 2026, making Narwhal Pro the second device in the company’s cartridge-powered cryoprobe portfolio. The new system complements the original Narwhal Cryo System by offering a shorter working length and direct compatibility with selected bronchoscopes from Olympus, Fujifilm and Pentax. By eliminating the need for a dedicated cryosurgical console, the technology aims to simplify equipment requirements while expanding clinicians’ options for lung tissue sampling, cryobiopsy and interventional pulmonology procedures. Maverix expects both Narwhal systems to become broadly available in the United States in 2027. The devices have received FDA clearance but are not yet commercially distributed.
FDA Clearance Expands Console-Free Cryoprobe Options
The Narwhal Pro Cryo System uses a single-use nitrous oxide (N₂O) cartridge to generate the extreme cold required for cryotherapy. Unlike conventional systems that may require dedicated capital equipment, the cartridge-powered design allows clinicians to use the disposable probe without purchasing or maintaining a separate cryosurgical console. The new device retains several features of the original Narwhal Cryo System, including a sharp, radiopaque 0.8 mm probe tip and compatibility with bronchoscopes featuring a working-channel internal diameter of at least 2.0 mm. Its shorter working length is specifically optimized for bronchoscopes measuring 600 mm or less, making it suitable for procedures using a range of commonly used shorter scopes. The Narwhal Pro also includes adapters for direct connection to compatible Olympus, Fujifilm and Pentax bronchoscopes. Integrated sheath and probe advancement controls allow clinicians to adjust positioning and manage how far the probe extends during a procedure. These features are intended to provide greater control during tissue sampling and other interventional applications. According to Maverix Medical, the Narwhal Pro is indicated for the palliative devitalization of tissue through extreme cold and cryo-adhesion. Its indicated applications include removing foreign bodies, mucus plugs, blood clots and necrotic tissue, as well as obtaining tissue biopsies and performing palliative recanalization of tissue tumors.
Cryobiopsy Research Highlights Diagnostic Potential
Cryobiopsy is an established bronchoscopic sampling approach that uses freezing to adhere tissue to a probe, allowing clinicians to retrieve specimens for pathological examination. It is particularly relevant to the evaluation of lung abnormalities, where obtaining adequate tissue can help guide diagnosis and subsequent treatment decisions. The company highlighted findings from the FROSTBITE-2 randomized clinical trial, published in JAMA in 2026. The study reported a 10% increase in diagnostic yield with a 1.1 mm cryoprobe compared with forceps transbronchial biopsy. Diagnostic yield measures how often a sampling procedure provides sufficient information to establish a diagnosis. These findings support continued evaluation of cryobiopsy as an option for bronchoscopic tissue acquisition. However, the reported study findings should not be interpreted as proof that every cryoprobe configuration will deliver the same results across all procedures or patient populations. Maverix Medical designed Narwhal and Narwhal Pro as complementary devices intended to give physicians more flexibility when selecting equipment for individual cases. The company’s strategy focuses on expanding access to cryobiopsy while reducing reliance on specialized capital equipment and accommodating different bronchoscope configurations.
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Narwhal Portfolio Targets Broader Clinical Adoption
The original Narwhal Cryo System received FDA 510(k) clearance on June 30, 2026, while Narwhal Pro received clearance on September 2, 2026. Both devices use the same basic cartridge-powered architecture but differ in working length, shaft dimensions and scope compatibility. The original Narwhal probe has a working length of 115 cm, compared with 74 cm for Narwhal Pro. Both feature a 0.8 mm tip, use a 14.3 g nitrous oxide cartridge and are designed for single use. Narwhal Pro includes scope adapters and a probe advancement mechanism tailored to shorter bronchoscopes. Thoracent, a Maverix Medical company, is expected to distribute both systems when commercial availability begins in the United States in 2027. The planned rollout will follow the devices’ regulatory clearances and precede broader clinical adoption. For the medical technology sector, the portfolio expansion demonstrates how device design can address practical workflow considerations in interventional pulmonology. By offering compatible cryoprobes for different scope lengths, Maverix aims to give clinicians more procedural flexibility in lung cancer diagnosis and other bronchoscopic applications. Future adoption will depend on availability, clinical experience and the needs of healthcare providers.
Source: Maverix Medical press release
