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end-ball technical information

end-ball technical information
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end-ball technical information

Product catalog summary
Overview: The INS 86 v5 is an intragastric balloon system designed for the non-surgical and temporary treatment of obesity. It works by occupying space in the stomach, creating a feeling of satiety and reducing food intake. This treatment is intended to be used alongside dietary and behavioral support.
Specifications:
  • Non-sterile, single-use with an 18-month expiry date.
  • Biocompatible, free from latex and phthalates.
  • Features an X-ray opaque valve and is MRI compatible.
  • Connectable to an endoscope.
  • Packaged in a peel-off sachet and box, to be stored under normal environmental conditions.
  • Comes with all necessary accessories.
Indications: Suitable for the treatment of obesity in adults with a Body Mass Index (BMI) of ≥ 28 kg/m².
Major Complications:
  • Abdominal pain, nausea, and vomiting in the initial days.
  • Gastric perforation and pharyngo-oesophageal injury.
  • Balloon migration leading to intestinal occlusion.
  • Gastric wall ulcer and acute pancreatitis.
  • Spontaneous balloon overinflation.
Procedure:
  • Insertion and extraction both take approximately 15 minutes under general anesthesia.
  • Treatment duration is 6 months.
Technical Specifications:
  • Balloon Pouch: Made of polyurethane, 0.2 mm thick, 110 mm in diameter.
  • Valve: Made of silicon, stainless steel, and polyurethane, dimensions L: 20 mm, Ø: 7 mm.
  • Introduction System: Made of silicone, stainless steel, PEHD, and PVC, length 1000 mm, distal part dimensions L: 126 mm, Ø: 15 mm.
Balloon Filling Protocol: The balloon is filled with 200 mL of air and 500 mL of liquid, totaling 700 mL.
Accessories: Includes a filling system (Reference ENDAC01), Luer lock syringe, extraction kit (ENDAC03), tubing for water inflation, 50 mL syringe, hollow needle, extraction clamp, and biconical connector.
Compliance: This medical device is CE marked and complies with NF EN ISO 13485:2016 standards.
Contact Information: Endalis, 1 Allée des Tilleuls, 69530 Brignais, France. Phone: +33 (0)4 37 57 57 00, Fax: +33 (0)4 37 57 57 01, Email: [email protected], Website: www.endalis.com
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Catalog excerpts

end-ball technical information-1

Technical sheet

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end-ball technical information-2

ENDT110 Technical specifications BALLOON Balloon filling protocol Reference ENDT110 V X0459 200 mL of air + 500 mL of liquide = 700 mL Accessories Filling system Reference ENDAC01 ce Luer lock syringe Tubing for water inflation Hollow needle - Extraction clamp biconical connector For more information, see our instructions for use and our guide downloadable on www.endalis.com This medical device is a regulated health product with carries CE marking in compliance with this regulation. For health professionals : Please read the instructions in the leaflet, user guide and on the labelling which comes...

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All Endalis catalogs and technical brochures

  1. User's manual
    User's manual

    8  Pages

  2. end-ball INFORMATION AND PATIENT FOLLOW-UP
    end-ball INFORMATION AND PATIENT FOLLOW-UP

    17  Pages

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