INDICATIONS FOR USE
The Obalon Balloon System (the “System”) is a swallowable intragastric balloon system indicated for temporary use to facilitate weight loss in adults with obesity (BMI of 30 – 40 kg/m2) who have failed to lose weight through diet and exercise. The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed.
The following contraindications apply to the Obalon Balloon System with Navigation and Obalon Touch:
- Anatomical abnormalities or functional disorders that may inhibit swallowing or passage through any portion of the entire Gastrointestinal (GI) Tract.
- Prior surgeries that may have resulted in intestinal adhesions, narrowing of any portion of the digestive tract or any other condition that may inhibit passage through any portion of the GI tract.
- Persons whom have undergone any bariatric surgery procedure.
- Inflammatory and other pathophysiological conditions of the GI tract.
- Chronic or acute use of medications known to be gastric irritants or to otherwise alter function or integrity of any portion of the GI tract, including but not limited to NSAIDs and aspirin.
- Untreated Helicobacter pylori infection.
- Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
- Patients diagnosed with bulimia, binge eating, compulsive overeating, high liquid calorie intake habits or similar eating related psychological disorders.
- Patients with known history of structural or functional disorders of the stomach including, gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (> 2 cm), cancer or any other disorder of the stomach.
- Patients requiring the use of anti-platelet drugs or other agents affecting the normal clotting of blood.
- Pregnant or lactating women, or women with an intention to become pregnant.
- Known history of duodenal ulcer, intestinal diverticula (diverticulitis), intestinal varices, intestinal stricture/stenosis, small bowel obstruction, or any other obstructive disorder of the gastrointestinal tract.
- Known history of irritable bowel syndrome, radiation enteritis, or other inflammatory bowel disease, such as Crohn’s disease.
- Patients taking medications on specified hourly intervals that may be affected by changes in gastric emptying, such as anti-seizure or anti-arrhythmic medications.
- Alcoholism or drug addiction.
- Individuals with active implantable devices, for example pacemakers or defibrillators, or with metal implants in the thoracic region.
- Radiography (digital X-ray or fluoroscopy) is recommended to confirm placement prior to balloon inflation when the balloon cannot be ascertained to be in the stomach or the capsule image is not displaying the expected balloon behavior as described in the Balloon Administration Procedure section and as observed by a qualified physician.
- To minimize radiation during administration, if fluoroscopy is utilized instead of digital x-ray, monitoring of the actual swallow process is not required to ensure successful placement and is not recommended. Radiation exposure should be minimized to the lowest possible level during radiographic confirmation if required after swallow and balloon inflation. The balloon must not be inflated until the capsule can be clearly identified to be in the stomach by the Navigation Console or radiographic verification.
- The risk of balloon deflation is significantly higher with balloons that are left longer than 6 months. Balloon deflation could lead to serious injury such as bowel obstruction requiring surgical repair.
- Death due to intestinal obstruction is possible and has been reported with other intragastric balloons.
- Patients reporting a loss of fullness, increased hunger, and/or weight gain should be examined by radiograph, as this may be a sign of balloon deflation. Additionally, any increase in nausea, vomiting and/or cramping after initial symptoms have subsided may indicate a deflated balloon. Patients should be evaluated by radiograph and endoscopic visualization might be required if the state of inflation cannot be determined radiographically. In the event of balloon deflation, the balloon should be removed as soon as possible.
- Each patient should be monitored closely during the entire device therapy period in order to detect the development of possible complications. Patients should be instructed regarding symptoms of deflation, gastrointestinal obstruction, ulceration, esophageal injury or perforation, gastric perforation, and other possible complications that could occur, and should be advised to contact their physician if these symptoms worsen over time or persist for more than 24 hours.
- Gastric perforation adverse events have been reported in patients with Obalon intragastric balloons. Some associated symptoms and findings noted in subjects who have gone on to have perforations are: New onset abdominal pain and/or back pain that persists beyond 24 hours, and persistent nausea and vomiting. PPI use may reduce the risk for ulcerations and subsequent perforations if untreated.
- Do not place more than 3 balloons in one patient across the 6-month therapy cycle.
- Do not place more than one device simultaneously. There should be no less than 14 days between balloon placements. Risk of intolerance due to too much initial volume may occur.
- Endoscopic retrieval might be required in the event that a capsule is swallowed, but not completely inflated. A foreign body retriever should be immediately available in the endoscopy suite.
- Patients must not use gastric irritant medications including but not limited to NSAIDs or Aspirin during use. This can lead to an increase in ulcerations, gastric bleeding events, and gastric perforations which could lead to death.
- Do not place balloons if the patient expects to permanently reside at an elevation greater than 4000 ft. from balloon placement elevation or lower than 2500 ft. from the balloon placement elevation. The risk of balloon deflation increases with significant change in elevation during balloon use.
- Underinflated balloons have also resulted from catheter breaches from bitten tubing. If the balloon is not properly inflated and not identified as underinflated, there is a risk for small bowel obstructions. If you suspect damage to the catheter the balloon must be removed endoscopically.
- An earlier than expected endoscopic removal may be required if there is a new onset of symptoms or ongoing gastrointestinal symptoms where an x-ray has ruled out balloon deflation or obstruction, but the patient’s symptoms remain unresponsive to other medical management methods.
- No modification of the Touch Dispenser is allowed.
- To avoid the risk of electrical shock, the Navigation Console must only be connected to a supply mains with protective earth.
- No modifications to the Navigation Console are allowed, unauthorized changes may impact performance and/or patient safety.
- Do not use the Navigation Console if any of the hardware components or connectors are damaged. Such damage may affect system functions and/or contribute to inaccuracy and possible patient/user injury.
- Do not use cables or accessories other than those provided with the Navigation Console. Doing so may result in increased emissions and/or decreased electromagnetic immunity of the console.
- Do not operate the console field generator within 10 m of another operating field generator. Doing so may contribute to inaccuracy and possible patient/user injury.
- Do not operate the console field generator within 200 mm of patients with an implanted pacemaker or defibrillator. The magnetic field produced by the field generator may interfere with the operation of these devices. This interference may result in patient/user injury.
- Disconnect power to the Navigation Console before cleaning, failure to do so may cause personal injury.
- The Obalon Balloon System procedure should only be conducted by trained physicians.
- Prior to use of the Obalon System, patients should have previously attempted to lose weight unsuccessfully using a medically supervised or non-medically supervised diet.
- Patients using medications known to affect weight or who are undergoing chronic steroid immunosuppressive therapy should not use the treatment.
- Patients should be advised not to undertake scuba diving or travel in an unpressurized airplane cabin as these activities might cause the balloons to deflate.
- The safety and effectiveness of the Obalon Balloon System has not been established in patients with:
- Type 1 diabetes.
- Type 2 diabetes requiring insulin or other hypoglycemic oral agents.
- Uncontrolled hypothyroidism or Cushing’s disease or syndrome.
- Severe, unstable/uncontrolled medical conditions of major organ systems.
- Patients with known cardiovascular disease such as recent acute coronary syndrome or clinically unstable ischemic cardiac disease including evolving or ongoing myocardial infarction, typical angina at rest, recent coronary intervention, recent deterioration of ECG, laboratory or clinical findings.
- Poorly controlled hypertension (≥ 160 mm Hg Systolic and ≥ 100 mm Hg Diastolic).
- End stage renal disease or requiring hemodialysis within the past 6 months.
- Do not use aerosol sprays near the Navigation Console as these sprays can damage the internal circuitry.
- Do not use any solvents to clean the Navigation Console. Solvents may damage the finish and remove labeling.
- Pull console connections apart by gripping the connector only. Do not pull them apart by tugging on the cable as this can damage the connecting cable. Never force a connection or a disconnection.
- Do not track in an untested application environment, as it may contain elements that affect Navigation Console functions. For example, the system can be adversely affected by electromagnetic field disturbances from other electronic objects in the room (such as cell phones), the proximity of metal, or the proximity of another Field Generator. Failure to test for such disturbances will increase the possibility of inaccurate transformations and possible patient injury.
- Do not expose sensors to a high magnetic field, such as a Magnetic Resonance Imaging (MRI) scanner, as they may become magnetized. Tracking with a magnetized sensor may result in incorrect transformations and result in possible patient injury.
- The sensors and console must be at least one foot (12 inches) away from any motor driven devices, ultrasound devices, diathermy equipment, cauterization equipment, mobile radiofrequency devices, or any other significant metal objects that may interfere with the sensors.
OBALON BALLOON MR SAFETY INFORMATION
Non-clinical testing demonstrated the Obalon Balloon is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
- Static magnetic field of 3 Tesla or less
- Maximum spatial field gradient of 4,000 gauss/cm (40 T/m)
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg (First Level Controlled Operating Mode)
Under the scan conditions defined above, the Obalon Balloon is expected to produce a maximum temperature rise of less than 3 °C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends approximately 5 mm from the Obalon Balloon when imaged with a gradient echo pulse sequence and a 3 Tesla MRI System.
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