Instructions for use

• Intra-gastric balloon

  Our device provides an appropriate solution for experienced gastroenterologists, anxious to offer a solution to patients suffering from obesity. The technical innovations for this new implant are aimed at improving patient quality of life, whilst reducing the risks linked to the device. The...

• Technical description

  The balloon and accessories are single use in order to: Reduce the risks of cross-contamination, infection, etc. Achieve its performance safely and effectively (insertion of the balloon) Simplify its use for practitioners (no cleaning, disinfection and sterilization procedures to be...

• Indications

  The intra-gastric balloon is a temporary, non-surgical device, the use of which is for 6 months or less. It is designed to enable weight loss when a monitored slimming program has not been sufficient. Nevertheless, the indications are: In patients adults with a BMI ≥ 28 kg/m² With or...

• Contraindications

  The presence of one of the following conditions is a contraindication to the insertion of the balloon: Previous history of gastric surgery; Digestive pathology: large hiatus hernia (> 5 cm), active peptic ulcers, severe oesophagitis either Grade III or IV (Savary-Miller classification) or...

• Extraction

  The extraction of the balloon is generally indicated due to: - Reaching the end of the recommended insertion period (6 months). Studies conducted on ENDBALL intra-gastric balloon support its safety and effectiveness just for a period of 6 months. - The occurrence of a complication: gastric...

• Complications

  Complications related to balloon deployment or removal: Above and beyond complications due to the upper digestive tract endoscopy (perforation or bleeding, bronchial inhalation as a result of gastric reflux, arrhythmia) or the anaesthetic, other complications are specifically associated with...

• Recommendations

  Before the procedure Treatment of patients with a view to inserting a balloon must be global. It must take place within multidisciplinary teams, liaising with the attending physician. These teams will include as a minimum a gastroenterologist, a doctor specializing in obesity (nutritionist,...

• Extraction of the balloon

  The extraction is a technically difficult procedure which must be performed: Under general anesthesia with tracheal intubation Under endoscopic control using the kits supplied by the manufacturers as first intention In the endoscopy room with equipment for monitoring vital functions and a...

• Warning

  The Company, ENDALIS®, does not exercise any control over the conditions of use, the choice of patient, the implantation and extraction procedures used, the pressures placed upon the device and the handling of the device after sale. The Company, ENDALIS®, cannot be held responsible for any...