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Obalon™ Gastric Balloon Instructions For

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Obalon™ Gastric Balloon Instructions For OBALON® BALLOON SYSTEM – INSTRUCTIONS FOR USE Balloon System Instructions for Use Caution: Federal (USA) law restricts this device to sale by or on the order of a physician Rx Only LIT-7500-0011-01 Page 1 TABLE OF CONTENTS (radiopaque marker) is below the gastroesophageal junction, then the balloon is then inflated. TABLE OF CONTENTS 2 INTRODUCTION 2 A fully inflated single balloon is an ellipsoid with a volume of approximately 250cc. When 3 balloons are placed, the total OBALON BALLOON-EZFILL INFLATION SYSTEM OVERVIEW 2 balloon volume is approximately 750cc. FACILITY REQUIREMENTS 3 After inflation is complete, the catheter is ejected from the INDICATIONS FOR USE 3 balloon valve and retrieved, leaving each balloon free-floating in the patient’s stomach. CONTRAINDICATIONS 3 Balloon use requires the concurrent use of Proton Pump WARNINGS 3 Inhibitors for the duration of implantation. Clinical studies have PRECAUTIONS 4 shown that use of 40 mg/day of omeprazole or an equivalent dosage of similar medications is required over the duration of ADVERSE REACTIONS 4 use. Anti-emetic and anti-spasmodic medication is required at WEIGHT LOSS PROGRAM REQUIREMENTS 5 least 24 hours prior to administration and should be prescribed in conjunction with balloon use for up to 5 days beyond balloon HOW SUPPLIED 6 administration. Pre-existing GI pathology must be ruled out ADDITIONAL ITEMS REQUIRED FOR DEVICE USE 6 prior to placement of any balloons by conducting a comprehensive medical history and Upper GI to determine a PRE-BALLOON ADMINISTRATION 6 patient’s suitability for the procedure and to ensure the patient PREPARATION FOR USE 7 is not contraindicated for device use. BALLOON ADMINISTRATION 7 The balloon therapy must be used in conjunction with a moderate intensity diet and lifestyle modification program to BALLOON INFLATION 9 achieve weight loss. The components of the program that are BALLOON USE 10 necessary to ensure device effectiveness are provided in more detail in the following sections. BALLOON REMOVAL 11 The balloons are only intended to remain in the stomach for 6 TROUBLESHOOTING 12 months from the time of placement of the first balloon. There STORAGE AND DISPOSAL 14 should be no less than 14 days between each balloon placement. All balloons placed must be removed at the end of 6 months CLINICAL STUDY DESIGN 15 after placement of the first balloon using endoscopy per the PRODUCT SPECIFICATIONS 24 specified tool dimensions. All placed balloons must be removed by a credentialed physician trained in endoscopy and foreign object retrieval. INTRODUCTION OBALON BALLOON-EZFILL INFLATION The Obalon Balloon System (the “System”) is designed to assist weight loss by partially filling the stomach. The System consists SYSTEM OVERVIEW of up to 3 intragastric balloons placed during a 6-month period. The Obalon Balloons must only be inflated utilizing the EzFill The balloons are swallowable in that they are delivered via Inflation System. The EzFill Inflation system consists of an EzFill capsule. Each balloon is placed individually within the first three Can and EzFill Dispenser. The EzFill Can is intended to provide a months. All three balloons are removed 6 months after the first gas source for transfer of a fixed volume of inflation gas to the balloon was placed. Obalon Balloon and the EzFill Dispenser is intended to serve as a method for transferring the fixed volume of the inflation gas to For administration, a Balloon Kit is used, which includes a the Obalon Balloon. balloon and catheter assembly. Each balloon is contained within a USP grade porcine gelatin capsule, which is attached to a The EzFill Inflation System is prepared prior to balloon catheter. The balloon capsule delivers the balloon in a similar administration away from the patient. The Extension Tube from manner that a medicinal capsule delivers pharmaceuticals. The the Accessory Kit is attached on the proximal end to the EzFill catheter comes pre-attached to the compacted balloon’s radio- Dispenser using a luer connection, while a 3-way stopcock valve opaque, resealing valve. on the distal end of the Extension tube remains closed. The green valve on the EzFill Dispenser is turned to the on position The administration (placement) procedure requires no sedation. and the EzFill Can is inserted into the Dispenser. The lever on the The catheter/capsule is swallowed by the patient. The catheter Dispenser is closed to secure the Can in place and actuate a is then attached to the EzFill Dispenser that contains an EzFill valve in the Can pressurizing the system; the Dispenser audibly Can (a can containing nitrogen-sulfur hexafluoride gas mixture) releases excess pressure in the Can via its mechanical pressure to fill the balloon. After the patient swallows a balloon capsule, relief system to ensure a starting pressure appropriate for the radiography must be done prior to inflation to ensure the altitude at which the system is operated. The Dispenser contains balloon is in the stomach (visualized by the radio-opaque a digital pressure gauge that provides a continuous read-out of marker). The preferred radiographic method is fluoroscopy or the pressure inside the Can. Prior to initiating each step in the digital x-ray since both provide real-time image of the balloon inflation process, the pressure gauge value is verified to ensure using low levels of radiation with immediate imaging feedback. that it is stable for at least 30 seconds (not changing more than Once there is radiographic confirmation that the balloon 0.3 kPa) at each decision point to ensure there are no leaks in the system. LIT-7500-0011-01 Page 2 After the capsule is swallowed, the EzFill Inflation System is • Allergies to products/foods of porcine origin. connected to the catheter by way of the Extension tube. All entries and exits within the Dispenser and Catheter connections • Patients diagnosed with bulimia, binge eating, compulsive are sealed and it is imperative that all system connections are overeating, high liquid calorie intake habits or similar fully secured during the procedure to maintain a closed gas eating related psychological disorders. pathway between the Can and Balloon. • Patients with known history of structural or functional The pressure gauge on the Dispenser must be monitored to disorders of the stomach including, gastroparesis, gastric ensure there are no leaks in the system during inflation. All ulcer, chronic gastritis, gastric varices, hiatal hernia (> 2 decision points require that prior to moving to the next step that cm), cancer or any other disorder of the stomach. the measured value is stable and does not change more than 0.3 • Patients requiring the use of anti-platelet drugs or other kPa in a 30 second period. Any value provided that is not stable agents affecting the normal clotting of blood. or unexpected could indicate that there is a leak in the closed loop system. • Pregnant or lactating women, or women with an intention to become pregnant. FACILITY REQUIREMENTS • Known history of duodenal ulcer, intestinal diverticula The health care setting in which the device is to be used must (diverticulitis), intestinal varices, intestinal have access to fluoroscopy or digital x-ray at the time the device stricture/stenosis, small bowel obstruction, or any other is administered in order to ascertain the balloon/capsule obstructive disorder of the gastrointestinal tract. placement in the stomach prior to inflation. In addition, the prescribing physician must have access to an endoscopy suite • Known history of irritable bowel syndrome, radiation and physicians credentialed in endoscopy and foreign object enteritis, or other inflammatory bowel disease, such as retrieval should problems arise during administration. Crohn’s disease. Endoscopy equipment and credentialed physicians trained in • Patients taking medications on specified hourly intervals endoscopy and foreign object retrieval is required for device that may be affected by changes in gastric emptying, such removal. as anti-seizure or anti-arrhythmic medications. INDICATIONS FOR USE • Alcoholism or drug addiction. The Obalon Balloon System (the “System”) is a swallowable intragastric balloon system indicated for temporary use to WARNINGS facilitate weight loss in adults with obesity (BMI of 30 – 40 • To minimize radiation, during administration, if fluoroscopy kg/m2) who have failed to lose weight through diet and is utilized instead of digital x-ray, monitoring of the actual exercise. The System is intended to be used as an adjunct to a swallow process is not required to ensure successful moderate intensity diet and behavior modification program. All placement and is not recommended. Radiation exposure balloons must be removed 6 months after the first balloon is should be minimized to the lowest possible level during placed. confirmation after swallow and balloon inflation. The balloon must not be inflated until the capsule can be CONTRAINDICATIONS clearly identified to be in the stomach. The following contraindications apply to the Obalon Gastric • The risk of balloon deflation is significantly higher with Balloon System: balloons that are left longer than 6 months. • Anatomical abnormalities or functional disorders that may • Death due to intestinal obstruction is possible and has inhibit swallowing or passage through any portion of the been reported with other intragastric balloons. entire Gastrointestinal (GI) Tract. • Patients reporting a loss of fullness, increased hunger, • Prior surgeries that may have resulted in intestinal and/or weight gain should be examined by radiograph, as adhesions, narrowing of any portion of the digestive tract this may be a sign of balloon deflation. Additionally, any or any other condition that may inhibit passage through increase in nausea, vomiting and/or cramping after initial any portion of the GI tract. symptoms have subsided may indicate a deflated balloon. • Persons whom have undergone any bariatric surgery Patients should be evaluated by Radiograph and procedure. Endoscopic visualization might be required if the state of inflation cannot be determined radiographically.
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