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The VisionAir Patient-Specific Airway Stent is indicated for the treatment of adults ≥22 years of age with symptomatic stenosis of the airway. The silicone stent is intended for implantation into the airway by a physician using the recommended deployment system or an equivalent rigid bronchoscope and stent placement system that accepts the maximum stent diameter being placed. The stent is intended to be in the patient up to 12 months after initial placement.

The subject device, VisionAir Patient-Specific Airway Stent is comprised of a cloudbased software suite and the patient-specific airway stent. These two function together as a system to treat symptomatic stenosis of the airway per the indications for use. The implantable patient-specific airway stent is designed by a physician using a CT scan as a guide in the cloud-based software suite. The airway is segmented from the CT scan and used by the physician in designing a patient-specific stent. When design is complete, the stent is manufactured via silicone injection into a 3D-printed mold and delivered to the treating physician nonsterile, to be sterilized before use. The implantable patient-specific airway stent includes the following general features: - Deployed through a compatible rigid bronchoscope system - Made of biocompatible, implant-grade silicone - Steam sterilizable by the end user - Anti-migration branched design - Anti-migration studs on anterior surface of main branch - Single-use The cloud-based software suite has the following general features: - Upload of CT scans - Segmentation of the airway - Design of a patient specific stent from segmented airway - Order management of designed stents

The Patient-Specific Airway Stent is indicated for the treatment of adults ≥22 years of age with symptomatic stenosis of the airway. The silicone stent is intended for implantation into the airway by a physician using the recommended deployment system or an equivalent rigid bronchoscope and stent placement system that accepts the maximum stent diameter being placed. The stent is intended to be in the patient up to 12 months after initial placement.

The Patient-Specific Airway Stent is comprised of Web Software and the Patient-Specific Silicone Y-Stent. These two function together as a system to treat symptomatic stenosis of the airway. The Patient-Specific Silicone Stent is designed by a physician using a CT scan as a guide in the Web Software. The Web Software gives the user (physician) the ability to upload a scan, view the airway, and design a stent. The stent, after physician approval, is manufactured via silicone injection into a 3D-printed mold and delivered to the treating physician's medical center nonsterile.