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The Ultraflex™ Tracheobronchial Stent System is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The Ultraflex Tracheobronchial Stent System is a permanently implanted expandable metal stent designed to serve as an intralumenal support to keep open the inner lumen of the tracheobronchial tree. They consist of a flexible delivery catheter preloaded with an expandable metallic stent. The stent is an open-ended cylindrical mesh constructed from a single strand of nitinol wire. The wire is configured into a series of circumferential interwoven loops, with the number of loops being dependent on the diameter of the stent. The stent is elongated and compressed onto a plastic delivery catheter. The stent is held onto the delivery catheter by a crocheted nylon suture wrapped around the stent. The delivery catheter has a flush taper tip at the distal end, and a round hub handle at the proximal end. The partially covered stent has a single layer of silicone that covers the midsection of the stent. Partially covered stents are available with a distal release system only. The distal release system begins stent deployment from the lower (distal) end of the delivery catheter. The uncovered stents are available with a distal or proximal release system. The radiopaque (RO) markers on the delivery system and stent facilitate fluoroscopic placement. The uncovered stent has one pair of RO markers indicated the approximate locations of the margins of the deployed stent. The partially covered stent has four (4) RO markers. The outer two (2) RO markers indicate the estimated final position of the ends of the deployed stent. The inner two (2) RO markers indicate the estimated final position of the margins of the deployed stent cover. The delivery system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire. The delivery system is passed over the guidewire into the tracheobronchial lumen. The stent is positioned appropriately using the RO markers for guidance under fluoroscopy and by bronchoscopic visualization of the stent.

The Through the Scope Tracheal Stent System is in the treatment of tracheobronchial strictures caused by malignant neoplasms.

The Through the Scope Tracheal Stent System consists of a flexible delivery system preloaded with a self-expanding implantable metallic stent. The stent is made of Nitinol wire weaved in a tubular mesh shape. This structure may make the stent more flexible, compliant and self-expanding. The stent is fully covered with silicone membrane and a polymer coating. The Parylene N is added on the surface of silicone membrane to restrict tumor in-growth through the wire mesh. A retrieval loop made of PE&PP is threaded through the proximal and distal ends of the stent and is intended to aid in removal during the stent placement procedure. The stent has different dimension with the diameters of 10mm, 12mm, 16mm, 18mm, with the lengths of 20mm, 30mm, 40mm, 50mm, 60mm, 80mm. The stent is deployed through the endoscopy working channel and under direct vision of endoscopy. The delivery system allows for desheathing to deploy and reposition the stent during the placement procedure. The delivery system consists of two coaxial sheaths and one inner core. The outer sheath serves to constrain the stent until being retracted during the stent deployment. The middle sheath serves to support the delivery system. The round tip acts as a guide when the delivery system enters the body. The front handle is used for deploying the stent. The seal ring, locking ring, and safe lock work to lock the device and prevent the stent from being exposed. The decoration nut connects with the back handle. The device is supplied sterile, intended for single use only, and is available for prescription use only. Use of this device is restricted to a trained healthcare professional.

The Tracheal Stent System (Y -Shaped) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.

The Tracheal Stent System (Y-Shaped) consists of a flexible delivery system preloaded with a self-expanding implantable metallic stent. The stent is made of Nitinol wire by weaving in a Y shaped. This structure design can make the stent more flexible, compliant and self-expanding. The stent is integrated Y-shaped stent, which include 1 main stent, 2 branch stents, the integrated Y-shaped stent can replace three straight shape stents, and the overall design of Y-shaped stent can also be used for the expansion of the carina if there are strictures at the carina. The stent is woven from Nitinol wire. The branch stent is formed with a flange at either end. The stent is partially covered with silicone to restrict tumor in-growth through the wire mesh. To aid in visibility under fluoroscopy there are radiopaque markers at the stent. There are 3 retrieval loops at the end of stent which can be used to reposition the stent during the initial placement procedure if desired. The device is supplied sterile, intended for single use only and is available for prescription use only. Use of this device is restricted to a trained healthcare professional.

The Tracheal Stent System (OTW) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.

The Tracheal Stent System (OTW) consists of a flexible delivery system preloaded with a self-expanding implantable metallic stent. The stent is made of Nitinol wire weaved in a tubular mesh shape. This structure may make the stent more flexible, compliant and self-expanding. The stent is partially or fully covered with silicone membrane and a polymer coating to restrict tumor in-growth through the wire mesh. A retrieval loop made of PE&PP is threaded through the proximal and distal ends of the stent and is intended to aid in removal during the stent placement procedure. To aid in visibility under fluoroscopy, there are Tantalum radiopaque markers at the body of the stent. The stent has flanges at the ends to aid in minimizing migration after

The HANAROSTENT® TracheaBronchium (CCC) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.

The HANAROSTENT® Trachea/Bronchium (CCC) is a self-expanding tubular prosthesis designed to maintain patency of tracheal or/and bronchial obstructions caused by malignant tumors. It consists of a self-expandable metal stent and a delivery device. The self-expandable metal stent is made of nickel titaniumalloy (nitinol) wire that is fully covered with a silicone membrane and has one repositioning lasso at one end of the stent. The delivery device is made of polymeric materials. The stent is loaded into the distal part of the delivery device and expanded in the body by pulling the outer sheath of the delivery device. The stent and delivery device are provided sterile and are intended for single use only.

The Merit ENDOTEK AEROmini™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The MERIT ENDOTEK AEROmini Tracheobronchial Stent System is comprised of two components: the radiopaque self-expanding nitinol stent and the delivery system. The stent is completely covered with a biocompatible polvurethane membrane. The stent expansion results from the physical properties of the metal and the proprietary geometry. The overall stent geometry is designed to maintain a constant length over the entire range of possible diameters. As a result of this unique design the stent has virtually no foreshortening, thus facilitating the selection of the appropriate stent length. The stent is deployed endoscopically with a dedicated delivery system with or without the aid of fluoroscopic imaging. The delivery system consists of two coaxial sheaths. The exterior sheath serves to constrain the stent until the sheath is retracted during deployment. The stent remains constrained by the delivery system until the trigger is pulled beyond the white deployment threshold mark located between the trigger and hand grip. This feature allows for repositioning of the stent proximally. A radiopaque tip and marker on the inner shaft aid the operator in determining stent position in relation to the deployment threshold mark, where repositioning or en bloc withdrawal is no longer possible. The inner sheath of the delivery system contains a central lumen that will accommodate a 0.035" guide wire. This feature is designed to allow guidance of the delivery system to the intended implant site while minimizing the risk of airway injury from the delivery system tip. The stent and delivery system are provided sterile using ethylene oxide (EO) process.

The WALLSTENT™ RP Endoprosthesis and WALLSTENT™ Endoprosthesis Tracheobronchial are indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The WALLSTENT RP Endoprosthesis Tracheobronchial and WALLSTENT Endoprosthesis Tracheobronchial are comprised of two components: The implantable metallic stent and the UNISTEP Plus delivery system. The stent is composed of biomedical superalloy wire, braided in a tubular mesh configuration. This design configuration results in a stent that is flexible, compliant, and self-expanding. The delivery system consists in part of coaxial tubes. The exterior tube serves to constrain the stent until retracted during delivery. Radiopaque marker bands situated on the interior and exterior tubes aid in imaging during deployment. Small stent sizes (5mm-12mm) may have a radiopaque core to improve radiopacity. The interior tube of the coaxial system contains a central lumen that accommodates a 0.035 in (0.89mm) guidewire.

The MERIT ENDOTEK AEROmini Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The MERIT ENDOTEK AEROmini Tracheobronchial Stent System is comprised of two components: the radiopaque self-expanding nitinol stent and the delivery system. The stent is completely covered with a biocompatible polyurethane membrane. The stent expansion results from the physical properties of the metal and the proprietary geometry. The overall stent geometry is designed to maintain a constant length over the entire range of possible diameters. As a result of this unique design the stent has virtually no foreshortening, thus facilitating the selection of the appropriate stent length. The stent is deployed endoscopically with a dedicated delivery system with or without the aid of fluoroscopic imaging. The delivery system consists of two coaxial sheaths. The exterior sheath serves to constrain the stent until the sheath is retracted during deployment. The stent remains constrained by the delivery system until the trigger is pulled beyond the white deployment threshold mark located between the trigger and hand grip. This feature allows for repositioning of the stent proximally. In addition, the procedure can be aborted and the entire system can be withdrawn en bloc at any time before the trigger is pulled beyond the white deployment threshold mark located between the trigger and hand grip. A radiopaque tip and marker on the inner shaft aid the operator in determining stent position in relation to the deployment threshold mark, where repositioning or en bloc withdrawal is no longer possible. The inner sheath of the delivery system contains a central lumen that will accommodate a 0.035" guide wire. This feature is designed to allow guidance of the delivery system to the intended implant site while minimizing the risk of airway injury from the delivery system tip.

The BONASTENT® Tracheal/Bronchial Stent System is indicated for the treatment of tracheobronchial strictures caused by malignant neoplasms.

The BONASTENT® Tracheal/Bronchial (BTB) is a self-expanding tubular prosthesis designed to maintain patency of tracheobronchial strictures caused by malignant tumors. The stent is made of Nitinol wire and is weaved using a hook & cross wire construction; a silicon membrane covers the stent and is designed to prevent stent migration. Stent sizes range in diameter from 10mm to 20mm and in length from 50mm to 80mm. The BONASTENT® Tracheal/Bronchial is available on two types of delivery devices. The Y-Shape Handle Delivery Device is used for stents with an outer diameter of 10Fr and less. The I-Shape Handle Delivery Device which is used for stents with an outer diameter larger than 10F.

The Ultraflex™ Tracheobronchial Stent System is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The Ultraflex Tracheobronchial Stent Systems are permanently implanted expandable metal stents designed to serve as an intralumenal support to keep open the inner of the tracheobronchial tree. They consist of a flexible delivery catheter preloaded with an expandable metallic stent. The stent is an open-ended cylindrical mesh constructed from a single strand of nitinol wire. The wire is configured into a series of circumferential interwoven loops, with the number of loops being dependent on the diameter of the stent. The stent is elongated and compressed onto a plastic delivery catheter. The stent is held onto the delivery catheter by nylon suture wrapped around the stent. The delivery catheter has a flush taper tip at the distal end, and a round hub handle at the proximal end. The covered stent has a single layer of translucent polyurethane that covers the midsection of the stent. Covered stents are available with a distal release system only. The distal release system begins stent deployment from the lower (distal) end of the delivery catheter. The radiopaque (RO) markers on the delivery system and stent facilitate fluoroscopic placement. The covered stent has four RO markers. The outer two (2) RO markers indicate the estimated final position of the ends of the deployed stent. The inner two (2) RO markers indicate the estimated final position of the margins of the deployed stent cover (Figure 1B). The delivery system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire. The delivery system is passed over the guidewire into the tracheobronchial lumen. The stent is positioned appropriately using the RO markers for guidance under fluoroscopy and by bronchoscopic visualization of the stent. The stent is deployed by holding the handle hub in the palm of one hand, and grasping the finger ring with the other hand. By retracting the finger ring the suture crochet knots are unraveled in a circular manner along the length of the stent, gradually deploying the stent. When using the proximal release system, stent deployment begins from the upper (proximal) end of the delivery system, and continues to release toward the tip of the delivery system (distally) as the entire suture unravels. When using the distal release system, stent deployment begins from the lower (distal) end of delivery system, and continues to release towards the operator (proximally) as the entire suture unravels. After the stent is completely released, and the nylon suture has been completely removed, the delivery system catheter can be removed.