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ESG/REVISE Important Safety Information

Apollo ESG™/REVISE™ Safety Information for Patients

  • Apollo ESGTM devices are made to help you lose weight by reducing the size of your stomach andincreasing the time it takes for food to pass through your stomach.
  • Apollo REVISETM devices are intended to help patients who have had previous gastric bypass but are struggling to lose weight or maintain weight loss. Apollo REVISE is used to reduce the size of the outletbetween the stomach and small intestine and may be used to reduce the size of your stomach as well. This is known as an ‘outlet reduction.’
  • For Apollo ESG or Apollo REVISE, you need to follow a healthy diet and exercise program to lose weight.You may not lose weight if you do not adopt healthy habits. Your doctor’s clinical team, including dieticians, nutritionists and/or exercise trainers, should help you on your weight loss journey.
  • Apollo ESG/REVISE devices are for adults with obesity (BMI 30-50kg/m2) who have not been able to lose weight and keep it off through more conservative measures (e.g. diet and exercise).
  • Your doctor will ask you about your medical history and will also perform a physical examination todetermine your eligibility for the Apollo ESG or Apollo REVISE device. Additionally, at the time of yourprocedure, the doctor may identify internal factors, such as stomach ulcers or erosive gastritis, which may prevent you from receiving the device.
  • You must not receive Apollo ESG or Apollo REVISE if you are pregnant.
  • You must not receive Apollo ESG or Apollo REVISE if you have an eating disorder (anorexia nervosa, binge eating disorder, etc.)
  • All procedures have risk. Patients should talk to their doctor and understand all risks before having aprocedure.
  • Nausea and vomiting, abdominal pain, constipation, eructation, constipation, heartburn and diarrhea are common after the ESG or bariatric revision procedure. Gastrointestinal bleeding may also be experienced following these procedures. More serious complications have been reported, though these are relatively rare.
  • While many patients are discharged from hospital on the day of their procedure, some patients may stay in hospital or return to hospital for assistance with symptoms associated with accommodating to the sleeve or outlet reduction. Symptoms are most often treated with IV fluids or medication, but medical intervention may be required.
  • Call your doctor if you have any concerns about your health or well-being following an ESG or bariatricrevision procedure.
  • Some patients may not lose weight following a procedure with Apollo ESG or Apollo REVISE. Others may lose weight and then report that they no longer feel full after a meal, like they did when they first had theirprocedure. In such cases, the sleeve or outlet may have been compromised. Talk to your doctor about your options. You may be a candidate to have the sleeve restored or the outlet reduced, or to have another type of weight loss procedure.
  • If you have additional questions, talk with your doctor. For full safety information, visit Apollo Endosurgery Directions for Use.