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Nitinotes

EndoZip

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The EndoZip system is a single-use endoscopic suturing/delivery system used by trained gastroenterologists or surgeons to create multiple internal gastric segmentations (endoscopic sleeve gastroplasty) that reduce stomach volume to facilitate weight loss in obese adults with a BMI of 30–40 kg/m².

Single usesingle patient, single sutureEtO sterile12 monthsshelf life from sterilizationLicensed physician onlySmall-diameter endoscope requiredVacuum pump requiredBMI 30–40 kg/m²adult obesity

Intended use

  • Intended to be used by trained gastroenterologists or surgeons who perform bariatric procedures, to facilitate weight loss by reducing stomach volume through endoscopic sleeve gastroplasty.
  • For adult patients with obesity, BMI 30–40 kg/m², who have not been able to lose weight or maintain weight loss through more conservative measures.
  • Indicated for obese adults with a BMI of 30–40 kg/m² in conjunction with diet and exercise.

Precautions

  • Verify compatibility of endoscopic instruments and accessories and ensure performance is not compromised; use only cleared or approved medical devices and only accessories/cables specified or provided by Nitinotes to avoid electromagnetic emissions/immunity problems.
  • Check and confirm that all cords or cables are connected correctly and securely; if the system does not function properly, turn it off and follow the Troubleshooting section.
  • Never store the system where it could get wet or be exposed to high temperature, humidity, direct sunlight, dust, or salt; keep the power supply clean during storage.
  • Portable RF communications equipment should be used no closer than 30 cm (12 inches) to any part of the EndoZip system; avoid using the device adjacent to or stacked with other electrical equipment (other than the specified endoscope and auxiliary equipment).
  • The system needs special EMC precautions and must be installed and put into service according to the specific EMC instructions.

Contraindications & warnings

Contraindications — Includes those specific to endoscopic suturing systems and any endoscopic procedure, which may include but are not limited to: use where endoscopic techniques are contraindicated; use with malignant tissue; large hiatal hernia; potential bleeding gastric lesions (e.g. ulcers, erosive gastritis, varices, or vascular malformations); affective disorders not under medical supervision or refractory to therapy and all eating disorders; women who are pregnant and/or breast feeding; patients under 18 years of age; coagulopathy and antiplatelet/anticoagulant therapy that cannot be corrected.

Warnings —
  • The EndoZip System should only be used according to the instructions and operating conditions described in the manual; failure to do so could result in compromised safety, equipment malfunction or instrument damage.
  • Each system is provided EtO sterile for single patient and single suture use. Do not sterilize, clean or re-use the device. Before use, confirm the package is not damaged and not expired — if the sterile barrier or device is damaged or the device is expired, DO NOT USE.
  • The system must be used only according to the manual and only by/under the supervision of licensed medical personnel; do not use for any purpose other than the intended application. It is single patient/single suture use — do not sterilize, clean or re-use. Confirm the package is undamaged and unexpired and that all companion devices function properly before use; if any endoscopic-system component is not functioning properly, do not perform the procedure. The EndoZip device must only be connected to the EndoZip power supply; if the device or power supply malfunctions, replace it rather than attempt repair. After use the product may be a biohazard and must be disposed of per applicable regulations.

Companion devices

  • Small-diameter endoscope
  • Standard off-the-shelf vacuum pump
  • EndoZip Power Supply (reusable)
  • OverTube sealing adaptor
  • Clamps
  • Endoscope holder

Handling & storage

  • Consists of single-use components (the EndoZip device containing the implants, plus accessories) and a reusable electrical power supply.
  • Device and accessories supplied sterile (EtO / Ethylene Oxide sterilization).
  • Shelf life of 12 months from the date of sterilization.
  • Single patient / single suture use — do not sterilize, clean or re-use; discard used devices properly after use.
  • Do not store where it could get wet or be exposed to high temperature, humidity, direct sunlight, dust or salt; maintain the power supply clean and ready for subsequent use.

For clinical orientation only — not medical advice. All content is aligned with the manufacturer's official recommendations.

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