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For maintaining open the airway, after dilation of the stenosis or resection of the obstruction, in particular in case of: - Tracheobronchial tumors - Tracheal stenoses with scarring - Stenoses following surgical anastomosis, resection or pulmonary transplantation.

The TRACHEOBRONXANE™ DUMON® stents are flexible tracheobronchial tubes made of medical grade silicone, designed to improve patient respiration capacity while acting as trachea or bronchi support. These medical devices are designed to conform to individual anatomies. Each stent has a specific treatment, to improve the evacuation of mucus in order to limit the risk of obstruction. A large range of shape, thickness and sizes is available depending on the pathology to be treated, patient intrinsic factor and location of the implantation. Indeed, the TRACHEOBRONXANE™ DUMON® range consists of various models which vary from each other in the following characteristics: - The stents type: TD, TF, BD, Y, ST corresponding to various profiles made of silicone with different hardness; - . The dimensions: each profile consists of different sizes in diameter and length; - The radiopacity: stents can be provided radiopaque or not radiopaque; barium sulfate . is added during the manufacturing process in order to make the stent radiopaque which allows obtaining a better visibility by X-rays radiography. The TRACHEOBRONXANE™ DUMON® stents have been designed with studs in order to facilitate their anchorage in the trachea or bronchi (on cartilage rings). The number of stud rows is depending on the stent profile and stent final destination (bronchi or trachea). The TRACHEOBRONXANE™ DUMON® stent holds the respiratory tract open by exerting a radial force.

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.

The main indications according to their frequency are : - 1. tracheobronchial tumors - 2. Tracheal stenosis with scarring - 3. Bronchial stenosis after surgical anastomotic, anastomoses resections or pulmonary transplantation. These stenoses have, as a common characteristic, the importance of the extrinsic compression or the collapse of the cartilingeous wall. The indication always focuses on an endoscopic therapeutic action, whether is concerns a resection or dilation. The stent insertion is indicated if the endoscopic resection is incomplete, in case of a persistent extrinsic compression, or if the lumen is insufficient. The most frequent locations are tracheal. The left main bronchus is the second location, followed by the right main bronchus.

the ENDOXANE® is an endoscopy stent made of silicone. This stent, the most fitted in the world, is presented as a silicone tube with stubs allowing to avoid any movement. The non armed polysiloxane is covered with a new coating especially designed in order to keep its' flexibility which facilitates tolerance and evacuation of secretions. A well-adapted ENDOXANE® does not move and cough reflexes are inhibited by reflex center saturation. The stubs prevent a direct contact between the stent surface and the mucus membrane and distribute the pressures among the small surfaces.