ELLA-CS, s.r.o.

SX-ELLA Stent Danis is intended for stopping the acute bleeding from esophageal varices. The stent implantation may be an option in refractory esophageal variceal bleeding as an alternative method to the early TIPS or the balloon tamponade.

• Removable stent for treatment of bleeding from esophageal varices

• Easy implantation without the need for endoscopy / X-Ray control

• Secure hemostasis through direct compression of varices

• Oral intake maintained from time of implantation

 Features / Benefits

• Variable pitches in stent braiding conform to esophageal peristalsis, reducing the risk of stent migration
• Standardized compression of the varices results in effective hemostasis
• Atraumatic edges
• Radiopaque markers at both stent ends and at the mid-point
• Retrieval loops with gold markers at both stent ends
• Easy endoscopic stent removal within 7 days by means of specific device – Extractor for SX-ELLA Esophageal Stents

Benefits of the Method

• Readily implantable without endoscopy / X-Ray , in emergency situations
• The stent lumen ensures physiological drainage of saliva. Oral ingestion of fluids and food is possible
• Detailed and repeated examination of the esophagus, cardia, stomach and duodenum, as well as suction of gastric contents, is possible immediately after insertion
• Use of the stent has been recognised by the Baveno V guidelines as an alternative for treatment of refractory variceal bleeding

• Early clinical experience – see Hubmann R. et. al.: The use of self-expanding metal stents to treat acute esophageal variceal bleeding. Endoscopy 2006; 38 (9): 896-901.

Contraindications

• Diagnosed malignancy or stricture affecting the esophagus
• Case history of irradiation therapy of the chest or the esophagus
• Malignancy of the throat, larynx, trachea, bronchi and stomach
• Esophagorespiratory fistula
• Esophageal bleeding due to injury of the upper GIT

Additional Description

Danis Procedure Pack consists of a plastic carry case containing all items required for stent implantation: Delivery system pre-loaded with stent, guide wire, plastic syringes, mouthpiece, kidney dish, slobber cloth, waste bag with clip, sterile gloves, instruction for use, patient´s card and self-adhesive product label. Nominal (relaxed) diameter of stent body is 25 mm, nominal diameter of flares is 30 mm, and nominal stent length is 135 mm.The delivery system 9.4 mm (28 F) / 6.6 mm (20 F) is available in a standard length of 60 cm. Pending Patent, Application No. #04466016.5, submited on July 1, 2004