Stents

Danis Procedure Pack SX-ELLA Stent Danis

Procedure Pack with SX-ELLA Stent Danis. Self-expandable nitinol stent preloaded in a ready-to-use delivery system. Complete procedure pack including all items required for implantation.

Features

• Variable pitches in stent weaving conform to esophageal peristalsis
– Reduced migration rates
• Standardized compression of the varices results in effective hemostasis
• Atraumatic stent ends
• Radiopaque markers at both stent ends and at the midpoint
– Acurate stent positioning
• Retrieval loops made of medical grade alloy at both stent ends
– High mechanical durability and acid resistance
• Easy endoscopic stent removal after 7 days
• Readily implantable without endoscopy
– X-Ray control, also in emergency situations
• Patient can continue an oral diet after stent implantation

Indications
– Acute bleeding from esophageal varices

Contraindications
– Esophageal strictures
– Recent radiotherapy of the esophagus
– Tumors affecting upper respiratory tract, esophagus or stomach
– Upper GIT bleeding from other causes (e.g. perforation)

Additional description

Danis Procedure Pack (019-08S-25-135) consists of a plastic carry case containing all items required for stent implantation:
Delivery system preloaded with stent, guide wire, plastic syringes, mouthpiece, kidney dish, slobber cloth, waste bag with clip, sterile gloves
Danis Procedure Pack Basic (019-08S-25-135-B) consists of: Delivery system preloaded with stent, guide wire, plastic syringe 50 ml
The delivery system 9.4 mm (28 F) / 6.6 mm (20 F) is available in a standard length of 60 cm

Article numbers

019-08S-25-135
019-08S-25-135 – B

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Esophageal Stent Danis Seal

Danis Seal is designed to give maximum support to assist in healing leaks.
Special innovative features make this stent the choice for this special indication.

Features

• Variable pitches in stent weaving conform to esophageal peristalsis
– Reduced migration
• Atraumatic stent ends
– Safety to use
• Radiopaque markers at both stent ends and at the midpoint
– Acurate stent positioning
• Retrieval loops made of medical grade alloy at both stent ends
– Simple endoscopic stent removal with ELLA Extractor
• Durable silicone covering
– High mechanical durability and acid resistance

Indications – Treatment of esophageal or gastric leakage from:
– Anastomotic wound dehiscence (esophagectomy, gastric bypass)
– Esophageal ruptures / perforations (spontaneous rupture – Boerhaave’s syndrome; iatrogenic rupture / perforation occurring during esophageal dilations, endoscopic manipulations, traumatic esophageal ruptures due to blunt thoracic trauma)
– Patients presenting with delayed esophageal or gastric leakage (to avoid esophageal diversion). The stenting is associated with decortication and muscle flap reinforcement

Contraindications
– Patients unable to pass endoscopy
– Esophageal, lung, tracheal and laryngeal malignancies or lymphoma producing non-healing leaks
– Non-viable / necrotic jejunal conduit forming gastric bypass
– Completely separated anastomosis

Additional description

Wide diameter of the stent aids optimal grip on esophageal wall.
Durable silicone covering with internal-smooth / external-roughened surface.
Smart wire pattern and flared ends reduce potential migration.
Narrow uncovered rims of the stent enable mucosal ingrowth for sealing stent-tissue interspace.
Durable metallic retrieval loops facilitate stent removal.

Article number

019-11-25-135

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SX-ELLA Stent Esophageal Degradable BD

BD Stent is designed for treatment of benign esophageal strictures (peptic, anastomotic, caustic) and achalasia resistant to standard therapy.

Features

• PULL delivery system
– Splittable olive tip
– Automatic detachment while stent starts releasing
– Prevention of olive entrapment
– Easy insertion and safe removal of delivery system
• Radiopaque markers
– Acurate stent positioning
• Anti-migration design
– Dual flared design
– Reduced migration rates
• Integrity and radial force of stent is maintained for 6 – 8 weeks following implantation
-Extended period of dilation compared to conventional methods
• Disintegration of stent occurs after 11 – 12 weeks following implantation
– No need for removal
• Simple compression procedure
– Compression tool available

Additional description

Stent is supposed to be compressed by compression tool into delivery system just prior to implantation.

5.9 mm / 9.4 mm (18 F / 28 F) delivery system, available in standard length of 75 cm

Recommended guide wire: 0.035” (0.89 mm) ultra stiff. Minimum length 220 cm

Article numbers

019-10A-23/18/23-060
019-10A-23/18/23-080
019-10A-23/18/23-100
019-10A-25/20/25-060
019-10A-25/20/25-080
019-10A-25/20/25-100
019-10A-28/23/28-060
019-10A-28/23/28-080
019-10A-28/23/28-100
019-10A-31/25/31-060
019-10A-31/25/31-080
019-10A-31/25/31-100
019-10A-31/25/31-135

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SX-ELLA Stent Esophageal HV – HV Stent Plus

HV Stent Plus is designed for palliation of malignant esophageal strictures, occlusion of esophagorespiratory fistulas and benign strictures resistant to standard therapy.
Stent system for fluoroscopic and / or endoscopic insertion.
Self-expandable fully covered nitinol stent preloaded in PULL delivery system.

Features

• Splittable olive tip*
– Automatic detachment while stent starts releasing
– Prevention of olive entrapment
– Safe removal of delivery system
• Retrieval loop made of medical grade alloy at proximal stent end
– High mechanical durability and acid-resistance
– Centripetal constriction of stentfl are
– Suitable for extraction by means of ELLA Extractor
• Radiopaque markers
– Accurate stent positioning
• Anti-migration collar**
– Reduced migration rates
• Atraumatic stent ends
– Reduction of esophageal wall irritation and hyperplasia
• Excellent flexibility
– Smooth alignment and adequate stent expansion along anatomical curves
• Durable silicone stent covering
– Prevention of tumor in-growth, occlusion of esophago respiratory fistulas

* Designed by: Hans-Ulrich Laasch, MD, MRCP, FRCR; Christie Hospital, Manchester, UK
** Designed by: UMC Utrecht, the Netherlands

Additional description

5.9 mm / 9.4 mm (18 F / 28 F) delivery system, available in standard length of 75 cm

Recommended guide wire: 0.035” (0.89 mm) ultra stiff – Minimum length 220 cm

Article numbers

019-09S-20-085
019-09S-20-110
019-09S-20-135
019-09S-20-150
019-09S-20-085-O
019-09S-20-110-O
019-09S-20-135-O
019-09S-20-150-O

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Extractor for SX-ELLA Esophageal Stents

ELLA Extractor is designed for extraction of SX-ELLA esophageal stents:
– SX-ELLA Stent Esophageal – Flexella
– SX-ELLA Stent Esophageal – Flexella Plus
– SX-ELLA Stent Esophageal HV – HV Stent
– SX-ELLA Stent Esophageal HV – HV Stent Plus
– SX-ELLA Stent Danis – Danis Stent

• Atraumatic stent capture
– Stent is completely retrieved into overtube prior to removal
– No shearing forces on esophageal wall
• Excellent radiopacity
– Stainless steel cable and radiopaque markers
– Precise fluoroscopic control
• Unique design
– Safe removal of stents from their original position or stents migrated into stomach
• Through-the-scope application
– Extraction cable is designed for use through working channel of standard endoscope (2.8 mm)
– Retrieval loop of stent is captured with arresting hook under direct vision

Removal recommendations
– Danis Stent, partially covered and uncovered stents should be removed within maximum of 7 (seven) days following implantation.
– after 7 days using extractor is not recommended.
– Removal of fully covered stents placed in benign strictures should be performed within 4 weeks after stent implantation.
– In addition ELLA Extractor may be used for retrieval of both covered and uncovered stents that migrated into stomach.

Additional description

9.4 mm (28 F) / 100 cm overtube with distal radiopaque marker

2.6 mm / 150 cm stainless steel extraction cable consisting of central wire with arresting hook and braided sheath

Article number

015-01-28-1000

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Endoscopic Marker

BLACK EYE™ Endoscopic Marker

The first and only non-India-ink-based product for marking the GI tract.

BLACK EYE™ is a sterile, non-pyrogenic solution designed to be used as an endoscopic marker for marking polyps and lesions in the gastrointestinal tract. It is supplied in syringes which contain 5ml of the marker solution.

The solution is sterilized and aseptically packed in the syringe. It is supplied sterile and disposable. BLACK EYE™ is indicated for endoscopically marking of lesion in the GI track.

BLACK EYE™ is both CE-marked and FDA cleared.

Article number
TS-205

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Mucosal Resection

EndoRotor®

The EndoRotor® is a next generation interventional resection device designed to address challenges of sessile lesions and incomplete resection.

The EndoRotor® is indicated for endoscopic resection of tissue from within the GI tract.

The tool resects and removes mucosal tissue simultaneously through a catheter inserted into the working channel of an endoscope.

This interventional tool replaces multiple instruments and the time necessary for instrument exchange.

Features
• Single resection tool designed for mucosal lesions
• Designed to address sessile/ flat lesions by suctioning and cutting in 1 motion
• Designed to address the challenges of tissue bridges
• Designed to address tissue around the lateral margin
• Has the potential to replace the need for multiple instruments with 1 and eliminate the time necessary for the exchange of multiple instruments

Article number
ER 10-01: 
Endorotor® Catheter
ER EGD 10-01: Endorotor® EGD Catheter
ERC 20-01: Endorotor® Console, with foot pedal and power cord
ER 30-01: Endorotor® Specimen Trap
ER 40-01: Endorotor® Filter

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Injection Needles

Endoscopic Needle
For use with Endoscopic Marker

The success of an endoscopic tattoo highly depends on the application of the endoscopic marker at the correct depth.

This needle is specifically designed for safe injection of the endoscopic marker at the correct depth.

Sharp, flexible and with the appropriate needle length for safe and accurate submucosal injection.

Features
– Very sharp needle tip specifically designed for safe and easy submucosal.
– Shielded tip prevents the needle from damaging the outer tube or the working channel.
– Strong outer tube facilitates easy advancement through complicated anatomic structures.
– Highly lubricant PTFE outer tube for easy passage through the working channel.
– User friendly handle design with easy locking mechanism makes the needle very comfortable to use.

Article number
– EMN2504

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Over the Scope Clip

Padlock Clip

The Padlock Clip™ is made of a flexible, biocompatible alloy with exceptional shape-retention memory.

• lt instantly springs back to its original form when deployed.
• lts circumferential approximation encircles the defect, and gathers, folds and compresses the tissue.
• Proprietary radial compression technology provides even 360° tissue compression.
• Precise tissue controllers limit penetration and moderate tissue-on-tissue pressure.
• Strategic capillary enabling gaps promote healthy blood flow.
• Result effective tissue closure that is resistant to GI pressures while still maintaining blood flow to promote “excellent healing”.
• The Lock-lt™ Delivery System provides fast and easy instrument mounting – less than a minute.
• Does not occupy an instrument channel.
• Large tissue chamber (1 cm x 1 cm) for substantial tissue. gathering prior to closure.
• Intuitive, precise thumb press deployment.

The Padlock Clip is indicated for
• Hemostasis for:
– Mucosal/Submucosal defects.
– Bleeding ulcers.
– Arteries – Polyps – Diverticula in the colon.
• Closure of GI tract luminal perforations < 20 mm that can be treated conservatively.
• Endoscopic marking of lesions.

Article numbers and sizes

C910001: Padlock Clip-12 for scoop tip diameter 9.5 – 11 mm
C913131: Padlock Clip-12 for scoop tip diameter 11.1 – 14 mm

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Miscellanous

Biteblocks

Bitebocks prevent costly bite damage to your scopes during upper endoscopy procedures. Our biteblocks are available in two sizes, for adults and
for children. The biteblocks are made of soft polyethylene and have very smooth, rounded edges and comfortable, non-latex straps.

The biteblocks have a large hole to accept al sizes of endoscopes. The biteblocks are single-use.

Adult Block
The adult biteblock includes an adjustable strap and accommodates up to a 60 French dilator (20mm).

Pediatric Block
Designed specifically for use with small children and infants. It includes an adjustable strap. Pediatric Block accepts up to a 48 French dilator (16mm).

Article numbers

JHY-KD-B1: Adult Bitebloc
JHY-KD-C1: Pediatric Bitebloc

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