To maintaining esophageal luminal patency in esophageal stricture caused by the intrinsic, extrinsic malignant tumors
Occlusion of concurrent esophageal fistulas
The non-covered Ultraflex esophageal stent system and the covered Ultraflex esophageal stent system allow placement of a self-expanding metallic stent within the esophagus. The system consists of a flexible delivery catheter preloaded with an expandable metallic stent available with or without a cover .the covered stent has a layer of translucent polyurethane that covers the midsection of the stent.
Both non-covered and covered stents are available in either of two different release systems.
- The distal Release system
- The proximal release system
The distal Release system begins stent deployment from the lower (distal) end of the catheter. The proximal release system begins stent deployment from the upper (proximal) end of the delivery catheter.
The radiopaque(RO) markers on the delivery system facilitate fluoroscopic placement.
The non-covered delivery system has two RO markers. These RO markers indicate the expected final position of the ends of the deployed stent.
The Ultraflex Esophageal NG Stent System is contraindicated for:
• Stent Placement for occlusion of esophageal fistula of any type, unless a covered stent is being used.
• The Placement in esophageal strictures caused by benign tumors, as the long-term effects of the stent in the
esophagus are unknown at this time.
• Strictures that cannot be dilated enough to pass the endoscope or the delivery system.
• Stent’s should place proximal end within 2 cm of the cricopharyngeal muscle. The stent must not Place in necrotic chronically bleeding tumors if bleeding is active at the time of placement and in polypoid lesions.
Placement in an esophagojejunostomy (following gastrectomy), as peristalsis may displace stent.
The following complications have been reported in the literature for the esophageal prosthesis. These include, but are not necessarily limited to:
- Procedural Complications
- Oxygen desaturation related to sedation
Post-stent Placement Complications
- Stent migration
- Tumor in-growth through stunt
- Tumor overgrowth around ends of a stent
- Foreign body sensation
- Food bolus impaction (lavage and debridement may be necessary on a periodic basis)
- Infection and Septic shock
- Recurrent dysphagia
- Fistula with trachea, bronchi, or pleural space (other than that due to normal disease progression)
- Death (other than that due to normal disease progression)
- Stent Fracture
- Tracheal compression/Airway compression