gastroduodenal FTRD®

Logo gastroduodenal FTRD

gastrodudodenal FTRD® for full-thickness resection  in stomach and duodenum To gastroduodenal FTRD®
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Description

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Use of the gastroduodenal FTRD®

A smaller FTRD® System for endoscopic full-thickness or deep wall resection (especially in the stomach) and diagnostic tissue acquisition in the stomach and duodenum.

The gastroduodenal FTRD® can be used for:

• not pretreated non-lifting adenoma
• non-lifting recurrent adenoma
• small subepithelial tumors
• early carcinoma

The gastroduodenal FTRD®

The gastroduodenal FTRD® consists of an applicator cap with a ready-to-use mounted FTRD® clip, integrated HF snare and thread, thread retriever, the endoscope sleeve with fixation tapes and FTRD® hand wheel.

For an easier and safer introduction of the system into the upper GI-tract (passage of esophagus and pylorus) the gastroduodenal FTRD® Set is delivered with an insertion balloon and guide wire.

For application, the applicator cap is mounted on the endoscope with the snare running on the outside of the scope and the sleeve preventing entrapment of any tissue between scope and snare. By turning the hand wheel, the thread is tensioned and the clip released. Using the integrated snare, the target tissue is cut above the clip.

The size of the gastroduodenal FTRD® is suitable for endoscopes with a diameter of 10.5 – 12.0 mm and a working channel diameter of at least 3.7 mm.

The gastroduodenal FTRD® Set

The gastroduodenal FTRD® is delivered as one procedure set and consists of the following products:

  • gastroduodenal FTRD®
    – gastroduodenal FTRD® cap with preloaded clip and thread
    – snare integrated into cap’s distal end
    – FTRD® hand wheel
    – thread retriever
    – endoscope sleeve with fixation tapes
  • FTRD® Marking Probe
  • FTRD® Grasper
  • insertion balloon
  • guide wire

For a better mobilization of the tissue in case of submucosal findings (especially in the stomach) a specially modified Anchor is available as a seperate item (not included in the procedure set).

The gastroduodenal FTRD® is not cleared for clinical use in the United States.

Dimensions and specifications

00_HF-Stecker_mM_IFU
Cap diameter (outside)19.5 mm
Cap depth23 mm
Appropriate endoscopesEndoscop diameter: 10.5 – 12.0 mm Working channel diameter: min. 3.7 mm
Packaging unit1 piece included in gastroduodenal FTRD® Set
Reference number of gastroduodenal FTRD® Set (incl. FTRD® Grasper, FTRD® Marking Probe, guide wire and insertion balloon)200.72

Important notes

The gastroduodenal FTRD® can be used with endoscopes with an outer diameter between 10.5 – 12.0 mm and a working channel diameter of at least 3.7 mm. All FTRD® products are disposable. Before purchase and use of the FTRD®, it is obligatory to participate in one of our FTRD® training courses.

The gastroduodenal FTRD® is not cleared for clinical use in the United States.

Application of the gastroduodenal FTRD®

Unlike the colonic FTRD®, the insertion of the gastroduodenal FTRD® is assisted with a guide wire and an insertion balloon.

Zeichnung mit Mundstück, gastroduodenal FTRD und vorgelegtem Führungsdraht

For an easier insertion, the use of a bite block
(size 20 or larger) is recommended

Step 1: FTRD® cap is positioned in front of the narrow section of the upper esophageal entrance

Vorschub des Ballons bis zur gelben Markierung

Step 2: The insertion balloon is inserted using a guide wire and is slid out of the FTRD® applicator cap up to the marking

Aufdilatieren des Einführballons

Step 3: Insertion balloon is filled with air
(approx. 15-20 ml)

Passieren der Engstelle mit aufdilatierem Einführballon

Step 4: gastroduodenal FTRD® is then carefully slid forward until narrow section is passed.

Vollständige Deflation des Einführballons und Rückzug in den Arbeitskanal

Step 5: After passage of esophagus deflate balloon completely and withdraw into working channel. Proceed accordingly for passage of pylorus.

Application process: Full-thickness resection with the FTRD® Grasper

  • Marking of lesion (FTRD® Marking Probe)
  • Mounting of gastroduodenal FTRD® to endoscope
  • Insertion of endoscope to resection site
  • Connect snare and HF generator
  • Positioning on resection site with endoscope
  • Grasping of tissue and mobilizing into cap (e.g. with FTRD® Grasper)
  • Ensure marked tissue is completely in cap
  • Fix FTRD® Grasper
  • Application of clip
  • Removal of security lock of FTRD® snare
  • Close snare
  • Resection of tissue with HF
  • Removal of endoscope with resection specimen (in cap)
  • Check resection site and specimen
  • Disposing FTRD® components
1. Anvisieren der markierten Läsion mit FTRD Greifer; 2. Greifen der Läsion; 3. Einziehen der Läsion in die FTRD Kappe 4. Clip Aplikation; 5. Integrierte Schlinge schließen und Gewebe resizieren

Application provess: Full-thickness resection with the Anchor

For submucosal lesions, especially with GIST indications or lesions in the stomach, the use of the Anchor instead of the Grasper may be necessary.

  • Marking of lesion (FTRD® Marking Probe)
  • Mounting of gastroduodenal FTRD® to endoscope
  • Insertion of endoscope to resection site
  • Connect snare and HF generator
  • Position Anchor on lesion (establish contact with tissue) and extend needles
  • Advance edge of the gastroduodenal FTRD cap towards the lesion and slowly maneuver the lesion into the cap
  • Ensure marked tissue is completely in cap
  • Fix Anchor
  • Application of clip
  • Removal of security lock of FTRD® snare
  • Close snare
  • Resection of tissue with HF
  • Removal of endoscope with resection specimen (in cap)
  • Check resection site and specimen
  • Disposing FTRD® components
1. Anvisieren der markierten Läsion mit FTRD System; 2. Anchor durch Arbeitskanal ausführen; 3. Anker auf Läsion positionieren und Nadeln ausfahren 4. Kappenrand auf Läsion führen und Lässion langsam in die Kappe manövrieren sowie Clip Aplikation; 5. Integrierte Schlinge schließen und Gewebe resizieren

Example*: EFTR of a GIST in the stomach with the gastroduodenal FTRD®

*Source: Dr. A. Schmidt, Department of Internal Medicine II, Gastroenterology, Hepatology, Endocrinology and Infectiology, University Hospital Freiburg

The gastroduodenal FTRD® is not cleared for clinical use in the United States.

Media

The gastroduodenal FTRD® is not cleared for clinical use in the United States.

Other products of the FTRD® System product family

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