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
- 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.
- 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.
- Malignant or benign strictures in the upper part of esophagus too close to the cricopharyngeal muscle
- 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.
MRI Safety Information
- The product is MRI Conditional, compatible with 1.5-Tesla and 3-Tesla magnetic field.
- 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.
|REF No.||Stent diameter [mm]|
Proximal flare / Body / Distal flare
|019-06S-20-085||25/20/24||85||No||14 F / 28 F - proximal release|
|019-06S-20-110||25/20/24||110||No||14 F / 28 F - proximal release|
|019-07S-20-085||25/20/24||85||No||18 F / 28 F - distal release|
|019-07S-20-110||25/20/24||110||No||18 F / 28 F - distal release|
|019-07S-20-135||25/20/24||135||Ne||18 F / 28 F - distal release|
|019-07S-20-150||25/20/24||150||Ne||18 F / 28 F - distal release|
|019-07S-20-085-O||25/20/24||85||Yes||18 F / 28 F - distal release|
|019-07S-20-110-O||25/20/24||110||Yes||18 F / 28 F - distal release|
|019-07S-20-135-O||25/20/24||135||Yes||18 F / 28 F - distal release|
|019-07S-20-150-O||25/20/24||150||Yes||18 F / 28 F - distal release|
|019-07S-18-085||25/18/25||85||No||16 F / 22 F - distal release|
|019-07S-18-110||25/18/25||110||No||16 F / 22 F - distal release|
|019-07S-18-135||25/18/25||135||No||16 F / 22 F - distal release|
|019-07S-18-150||25/18/25||150||No||16 F / 22 F - distal release|
|019-07S-18-085-O||25/18/25||85||Yes||16 F / 22 F - distal release|
|019-07S-18-110-O||25/18/25||110||Yes||16 F / 22 F - distal release|
|019-07S-18-135-O||25/18/25||135||Yes||16 F / 22 F - distal release|
|019-07S-18-150-O||25/18/25||150||Yes||16 F / 22 F - distal release|