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HANARO STENT ® Duodenum/Pylorus Lasso (NNN) (NCN) - 7 Pages

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Catalogue excerpts

HANAROSTENT® Duodenum/Pylorus Lasso (NNN) HANAROSTENT® Duodenum/Pylorus Lasso (NCN) Warning ■ Please read these instructions carefully prior to use! ■ For single use only! ■ Re-sterilization is prohibited! Indications for Use This stent is indicated for application in palliative treatment of pyloric or duodenal stricture caused by malignant tumors. Contraindications This stent is contraindicated for: - Strictures that cannot be dilated enough to pass the delivery device - Chronically bleeding tumors, if bleeding is active at the time of placement - Patients for whom the endoscopic treatments are contraindicated - Multiple sites of obstruction - Standard endoscopy contraindications - Strictures caused by benign tumors - Any use other than those mentioned in Indications for Use. Precaution 1. The physician should be aware of: Migration caused by peristalsis and/or tumor decrease in volume due to radiotherapy and/or cytostatic agent. Stent rupture caused by the strong peristalsis after stent placement depending on patients’ condition. 2. This device should be used only by physicians who are familiar with and experienced in stenting technique and post-stenting patient care. 3. This device is sterilized. Please inspect the device carefully prior to use to verify that the device has not been damaged during the shipment, and that its sizes are suitable for the stenting procedure. Do not use it if its package is opened or damaged.

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4. Re-use or re-sterilization may cause the stent deformation and/or direct infection or cross-infection on patients that may result in pain, injury or death of patients. 5. Implantation of stent should be performed under the fluoroscopic and/or endoscopic guidance. 6. Do not insert the delivery device when the stent is partially deployed. 7. The stent is not intended to be removed or repositioned after the stent placement. Repositioning and removing stent after placement may break and damage the silicone membrane and/or wire mesh. HANAROSTENT® Duodenum/Pylorus Lasso(NNN) and HANAROSTENT® Duodenum/Pylorus...

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Stent Descriptions HANAROSTENT® DUODENAL/PYLORUS LASSO (NNN) 1. This stent is a self-expanding nitinol tubular prosthesis. 2. Total of 12 radiopaque markers, 4 on each end and 4 at the center, create clear fluoroscopic view of the stent. 3. Flare ends of the stent assist to minimize the migration caused by peristalsis. 4. The repositioning lasso is attached to the proximal end for repositioning. 5. MRI free. (3 Tesla or less) 6. Various diameters and lengths are available. The size of stent is described in its label on the package. HANAROSTENT® DUODENAL/PYLORUS LASSO (NCN) 1. This stent is a self-expanding...

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1. The delivery device is composed of an olive tip, a radiopaque ring, an outer sheath, a sheath handle, a safety lock, an inner shaft and a shaft handle. 2. The distal end of outer sheath has a radiopaque ring made of tungsten to visualize the distal end of delivery device by fluoroscope during the procedure. 3. The safety lock prevents an accidental deployment of the stent while the delivery device is being introduced over the guidewire. 4. The size of delivery device is described in its label on the package. [Type 1] for HANAROSTENT Duodenum/Pylorus (NCN) [Type 2] for HANAROSTENT Duodenum/Pylorus...

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1. Insert a guidewire fully across the stricture. 2. Insert the delivery device carefully over the guidewire after making sure that the safety lock is firmly fixed. 3. Unlock the safety lock after checking that the delivery device is well positioned. 4. Immobilize the inner shaft by firmly holding it with one hand and then slowly pull the outer sheath backwards to start extruding the stent from the delivery device. 5. Remove the delivery device after the stent is completely placed. Caution 1. Do not push or pull the inner shaft while deploying the stent. Pushing or pulling the inner shaft will...

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3. If the olive tip gets caught in the distal part of stent or inside the stent lumen due to the tight stricture, wait for a while until the stent expands more and/or gently move the whole delivery device back and forth several times in order to free it. 4. When using the alligator type of grabbing forceps for repositioning, it is recommended to grab a tip of the lasso instead of grabbing a body of the lasso in order to prevent a repositioning lasso break. Post-Procedures 1. A water-soluble enema examination is performed immediately after the procedure or the following after the procedure or the...

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Subsequent follow-up is required after the stent placement to make sure that the stent maintains the original position and shape. Periodic follow-up depends on the condition and the behavior of the patient, but it must be performed in 1st week and 3 month intervals. 6. If stent rupture or migration are suspected or detected while following it up, either fluoroscopic or endoscopic examination is required. Depending on the physician’s decision, a new stent or stent-in-stent placement may be considered. 7. After stent placement, chemotherapy and radiation are not recommended, as this may increase...

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