Medical products

Enterella Pyloroduodenal

SX-ELLA Stent Pyloroduodenal - ENTERELLA

SX-ELLA Stent Pyloroduodenal - ENTERELLA

  • Easy deployment
  • Excellent flexibility
  • Atraumatic stent ends
  • Smooth alignment around flexures

Basic Description

SX-ELLA Stent Pyloroduodenal (Enterella) is a self expandable nitinol stent with high flexibility, suitable for difficult anatomical structures. The stent is designed for traversing of malignant strictures of the pyloroduodenal region.

Indications

Enterella Pyloroduodenal is indicated for palliative treatment of gastric outlet syndrome or duodenal strictures and/or obstructions caused by malignant tumors.

 Contraindications

  • Enteral ischemia
  • Bowel perforation
  • Peritoneal abscess
  • Severe ascites
  • Severe coagulopathy

 Features / Benefits

  • Atraumatic stent ends / Effective prevention of trauma to gastric / duodenal wall
  • Excellent flexibility / Precise alignment around anatomical curves
  • Radiopaque markers at both stent ends and at the mid-point / Improved visibility / Accurate stent positioning
  • Plastic repositioning loop at the proximal stent end / Possibility of correcting the stent position within five days after its implantation
  • Specially braided catheter / The delivery system is kinking-resistant even in considerable curves
  • The stent is delivered under fluoroscopic and/or endoscopic control

 Additional Description

  • 10,5 F (3.5 mm) delivery system available in a standard length of 210 cm allowing passage through the working channel of an endoscope. Radiopaque, atraumatic tip of the delivery system. Designed for use with 0.035" (0.89 mm) guide wires.

 

Fig. 1 - SX-ELLA Stent Pyloroduodenal - ENTERELLA

Fig. 2 - Enterella Pyloroduodena delivery system

 

Esophageal Degradable

 SX-ELLA Stent Esophageal Degradable BD - BD STENT

SX-ELLA Stent Esophageal Degradable BD - BD STENT

  • Biodegradation
  • Excellent flexibility
  • Radiopaque markers
  • Splittable olive tip

 Basic Description

Stent system for treatment of benign esophageal strictures.

BD - after deployment 4 weeks

Indications

BD Stent is designed for relieving benign esophageal lesions, namely:

  • Stenosis (peptic, anastomotic or caustic) refractory to standard therapy,
  • Achalasia refractory to standard therapy.

Contraindications

Inability to pass the 9.4 mm (28 F) delivery system through the stricture

Benign stricture in the upper part of esophagus too close to the cricopharyngeal muscle

Patients with benign strictures due to previously performed laryngectomy

Features / Benefits

  • Stent integrity and radial force of the stent is maintained for 6 – 8 weeks following implantation / Extended period of dilation compared to conventional methods
  • Stent disintegration occurs 11 - 12 weeks following implantation / No need for removal
  • Dual “flared ends” stent design / Reduced migration rates
  • Radiopaque markers at both stent ends / Accurate stent positioning

Additional Description

The stent is delivered sterile and packed separately from the delivery system. It is manually loaded into the delivery system immediately prior to implantation.

The use of a 0.035” (0.89 mm) / 220 cm stiff guide wire is recommended.

NOTES

  • The pH influences the process of degradation of the stent. Low pH (e.g. due to GE reflux) accelerates the degradation.

 

Delivery system
Active length: 75 cm
Proximal diameter: 5.9 mm (18 F)
Distal diameter (containing the stent): 9.4 mm (28 F)

 

 

Available Sizes

table bd

 

Esophageal HV Stent Plus

SX-ELLA Stent Esophageal HV - HV Stent Plus

SX-ELLA Stent Esophageal HV - HV Stent Plus

  •  Unique delivery system
  • Removable esophageal stent
  • Special anti-migration design
  • Excellent flexibility
  • Acid-resistant retrieval loop
  • Atraumatic stent retrival

 Basic Description

 SX-ELLA Stent Esophageal HV Plus is a reliable medical device intended for relieving obstructions in the esophagus, no matter if in upper, middle or lower part. If the stent is deployed in lower part of the esophagus when reaching cardia and stomach, it can be equipped with an anti-reflux valve to prevent gastric juice reflux. Implantation of the stent should be performed under fluoroscopic and/or endoscopic guidance. To decrease the migration rate, the HV STENT PLUS is equipped with an anti-migration collar.

Indication

  • HV Sten Plus is designed for relieving malignant or benign esophageal strictures if standard operation is contraindicated. It can be used for treatment of esophagorespiratory fistulas as well.

Contraindications

  • Malignant or benign strictures in the upper part of the esophagus too close to the cricopharyngeal muscle

Relative Contraindications

  • Use of the valved stent shall be carefully considered in patients after partial gastrectomy which produced small, horizontally lying gastric remnant. Distal end of migrated stent might impact into the gastric wall and consequently close the valve.

Additional Description

  • The construction of the HV STENT PLUS and the material used guarantee a sufficient expansion force.
  • Esophageal HV STENT PLUS (fig. 1) is braided of a wire made of nickel-titanium alloy – nitinol. This material has unrivaled flexibility, shape memory and durability.
  • The stent is hand braided therefore the ends are non-traumatic.
  • The radiopacity of the stent is secured by markers, made of platinum-iridium alloy, that are fixed to a stent mesh.
  • The covering of the stent is made of durable silicone. Thus prevention of tumor in-growth and occlusion of esophagorespiratory fistulas are achieved.
  • To decrease the risk of migration to the very minimum, HV STENT PLUS is equipped with an unique anti-migration collar.
  • If the stent is to be implanted into the lower part of the esophagus, it may be optionally equipped with an anti-reflux valve.
  • The delivery system of the HV STENT PLUS is equipped with a special splittable olive (fig. 2). This part of the delivery system splits off during the stent placement. This unique feature allows smooth and easy delivery system removal.

Fig. 1 - SX-ELLA Stent Esophageal HV (HV Stent Plus)

Fig. 2 - Delivery system with an olive release system

 Miscellaneous Important Facts

  • A physician to implant the HV STENT PLUS stent shall be skilled appropriately.
  • Stent shall be introduced by using the ultra stiff guide wire only.
  • Stent implantation should be performed under fluoroscopic and/or endoscopic control.
  • Proximal end of the stent shall be placed out of the tumorous stricture, i.e. in a healthy tissue.
  • Instructions describing correction of stent misplacement/partial migration or its removal from the stomach after full migration shall be strictly followed.
  • The patient shall eat semi-solid food and drink plenty of liquids after implantation.
  • Once even a small portion of the stent is released from the delivery system, it is strictly prohibited to push the delivery system forward to prevent stent damage and potential patient injury
  • It is recommended to dilate the esophageal stricture to the minimum diameter of 10 mm.

 Table for HV Stent Plus

 

Esophageal Stent Danis

SX-ELLA Stent Danis

SX-ELLA Stent Danis

  • 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

 Basic Description

Procedure Pack with SX-ELLA Stent Danis

Complete procedure pack including all items required for implantation (e.g. syringe for inflation of gastric balloon, mouthpiece, etc.). Self-expandable nitinol stent covered by plastic membrane and preloaded in a ready-to-use delivery system.

There are two types of Danis sets available:

  • Danis Procedure Pack (containing all accessories)
  • Danis Procedure Pack Basic (containing stent (preloaded in the delivery system), guide wire and syringe)

SX-ELLA Stent Danis

Danis pack

Indications

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.

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

 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.

 

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

 

 

 

 

Esophageal Stent Flexella Plus

SX-ELLA Stent Esophageal - FLEXELLA PLUS

SX-ELLA Stent Esophageal - FLEXELLA PLUS

 

  • Unique delivery system
  • Removable esophageal stent
  • Anti-migration and atraumatic design
  • Excellent flexibility
  • Acid-resistant retrieval loop
  • Atraumatic stent retrival

 Basic Description

  • SX-ELLA Esophageal stent FLEXELLA PLUS is designed to relieve malignant esophageal strictures in all parts of the esophagus with respect to necessary 2-cm distance from the upper esophageal sphincter.
  • If the stent is deployed across the gastroesophageal junction, it should be equipped with an anti-reflux valve to prevent reflux of gastric juice.
  • Implantation of the stent should be performed under fluoroscopic guidance.
  • The FLEXELLA PLUS is routinely distributed in a delivery system with distal release mechanism. The stent is deployed by pulling the sheath (PULL SYSTEM). As an alternative, we offer also delivery system with proximal stent release (PUSH SYSTEM) in which the stent is deployed by pushing the shaft.

Indications

  • Flexella Plus is designed for relieving malignant or benign esophageal strictures if standard operation is contraindicated. It can be used for treatment of esophagorespiratory fistulas as well.

 Contraindications

  • Malignant or benign strictures in the upper part of esophagus too close to the cricopharyngeal muscle

 Relative Contraindications

  • Use of the valved stent shall be carefully considered in patients after partial gastrectomy which produced small, horizontally lying gastric remnant. Distal end of migrated stent might impact into the gastric wall and consequently close the valve.

Additional Description

  • Esophageal stent FLEXELLA PLUS (fig. 1) is braided of a wire made of nickel-titanium alloy – nitinol. This material has unrivaled flexibility, shape memory and durability.
  • The stent is hand braided therefore the ends are non-traumatic.
  • The radiopacity of the stent is secured by markers, made of platinum-iridium alloy, that are fixed to a stent mesh.
  • The covering of the stent is made of durable silicone. The construction of the stent FLEXELLA PLUS and the material used guarantee a sufficient expansion force.
  • The shape of the FLEXELLA PLUS decreases the risk of stent migration.
  • If the stent is to be implanted into the lower part of the esophagus, it may be optionally equipped with an anti-reflux valve.
  • The delivery system of the stent FLEXELLA PLUS is equipped with a special splittable olive (fig. 2). This part of the delivery system splits off during the stent placement. This unique feature allows smooth and easy delivery system removal.
  • Stent is also available in delivery system with proximal release (fig. 3) that is suitable for strictures in the upper part of the esophagus, where the exact location of the upper edge of the stent is required.
  • It is recommended to dilate the esophageal stricture to the minimum diameter of 10 mm.

Fig. 1 - SX-ELLA Stent Esophageal - FLEXELLA

 Fig. 2 - Delivery System PULL

 

 Fig. 3 - Delivery System PUSH

 

Miscellaneous Important Facts

  • A physician to implant the stent FLEXELLA PLUS shall be skilled appropriately.
  • Stent shall be introduced by using the ultra stiff guide wire only.
  • Stent implantation should be performed under fluoroscopic and/or endoscopic control.
  • Proximal end of the stent shall be placed out of the tumorous stricture, i.e. in a healthy tissue.
  • Instructions describing correction of stent misplacement/partial migration or its removal from the stomach after full migration shall be strictly followed. Changing the stent position after the period longer than 5 days since the date of implantation shall be well-considered because a part of the stent may be incorporated into the esophageal mucosal tissue at that time.
  • The patient shall eat semi-solid food and drink plenty of liquids after implantation.

Once even a small portion of the stent is released from the delivery system, it is strictly prohibited to push the delivery system forward to prevent stent damage and potential patient injury.

Table Flexella Plus

 

Information

Contact Us

  • Unit 13, No. 1, Pardis Deadend, After Beheshti St., Vali Asr Ave., Tehran , Iran
  • Tel : (+98) 21 88701077
  • This email address is being protected from spambots. You need JavaScript enabled to view it.
  • Working Time: 8:30-18:00

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