END BALL - Intra-Gastric Balloon System

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 implemented by users)
• The balloon is punctured during removal

Furthermore, ENDALIS® has not demonstrated that its device is compliant with the basic requirements of Directive 93/42/CEE and its amendment 2007/47/CEE, if it is re-used.

Consequently, the practitioner exposes himself to serious risks (see below) if he reuses this single use device.

Characteristics

Balloon END T110

• Single pouch polyurethane balloon
• Size of the balloon empty:  Flat 110 mm disc
• Volume of inflation 700 ml liquid and air

Biocompatibility

Device compatible with the human body (NF EN ISO 10993).

Packaging

The device is delivered NON-STERILE.  The device is packaged in a peel-back sachet, heat sealed and packed in a case together with the following materials.

• Instructions for use of the medical device
• User manual
• Individual identification card
• Identification labels for the files

Its microbiological cleanliness is controlled by the manufacturing conditions in the controlled atmosphere room (followed by a bioburden in each batch) and preventive treatment to ETO. Devices are delivered STERILE and are for SINGLE USE (they have CE marking from a different manufacturer to Laboratoire ENDALIS®).

Storage

To be kept in a cool, dry place at ambient temperature.

Disposal of waste

After use all our products must be considered as medical waste carrying a risk of infection and related risks (D.A.S.R.I. in France).

It is ESSENTIAL that the procedure for sorting and disposal established in the user health establishment is followed.

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 not the comorbid factors (HT, Sleep apnea, diabetes, …)
• Before bariatric surgery
• In patients with a contraindication to bariatric surgery
• In the context of orthopedic surgery

At 6 months in the order of 34% of the excess weight corresponding to a weight loss of about 16 kg.

There is currently no significant study on maintenance of the weight loss over time.

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 Grade C or D (Los Angeles classification), Crohn`s disease or any other digestive tract lesion that could bleed, pyloric stenosis and anomalies in the structure of the digestive tract
• Diseases which could affect the vital prognosis in the short to medium term
• Severe cognitive or mental disorders
• Severe eating disorders that are not stabilized
• Alcoholism, drug addiction
• Treatment with platelet aggregation inhibiting drugs or non-steroidal anti-inflammatory without adjuvant treatment with acid-blockers
• Anticoagulants
• Foreseeable inability of the patient to take part in a prolonged medical follow-up
• Absence of previously identified medical treatment
• Pregnancy, desire for a pregnancy during treatment with the balloon
• Severe liver disease
• Haemostatic disorder
• Helicobacter pylori infection.

Some of these contraindications may be temporary.

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 perforation, gastric ulcer or erosion, intestinal obstruction, deflation and migration of the balloon
• Intolerance to the balloon particularly due to vomiting or persistent abdominal pain
• Incorrect positioning of the balloon in the stomach (balloon blocked, not free in the gastric antrum)
• Unusual appearance of the balloon (bag slack, balloon shrunk, etc.).

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, endocrinologist or specialist in internal medicine), a dietician, a psychiatrist or psychologist and an intensive care anesthesiologist.  These teams can take the advice of other health professionals as required (surgeon, endocrinologist specializing in diabetes, radiologist, cardiologist, doctor specializing in lung disease, rheumatologist, rehabilitation doctor, dentist, physiotherapist, etc.)
• The patient must be informed of the advantages and disadvantages of the balloon (including failure rates, and complications), the obligation to remove the balloon after 6 months, the necessity of multidisciplinary treatment and long-term follow-up.
• Patients must be advised on contraception
• The decision to insert the balloon must be taken after discussion and consultation with the multidisciplinary team
• Before the procedure routine pregnancy testing using a plasma b-HCG assay should be performed for women of childbearing age
• Testing for and treatment of a Helicobacter pylori infection is not routine but left to the discretion of the operator.

During the implementation of the procedure

Cleaning: No cleaning is necessary. In no circumstances must the product be sterilized as no procedures have been validated for the product. Do not soak the product in disinfectant.  The material may absorb some of the solution and cause a tissue reaction.

Anesthesia: An anesthesiologist will be solely responsible. The balloon must be inserted under general anesthesiologist with or without tracheal intubation, under endoscopic control in the endoscopy room with equipment for monitoring vital functions and a respirator, by professionals who have received specific training in a referral center already practicing these procedures.

• Insertion:
  • General anesthesia using Propofol, a short-term anesthetic drug  (e.g. Diprivan or a generic)
  • Spontaneous ventilation
  • Duration: ~15 minutes
• Extraction:
  • General anesthesia using Propofol, a short-term anesthetic drug  (e.g. Diprivan or a generic)
  • Patient intubated and ventilated
  • Duration: ~15 minutes

Insertion: The intra-gastric balloon system END can be used on an endoscope

A control endoscopy is recommended to check:

• The integrity of the esophagus, cardia and stomach.
• Photographs of all these anatomical parts should be taken and placed in the patient`s file.

After the procedure

• A control endoscopy is recommended to check the correct inflation of the balloon (bag under tension, smooth appearance, etc.) and the correct positioning and freedom of movement of the balloon in the gastric antrum
• A progressive re-feeding protocol will be prescribed
• A blood ionogram and creatinemia are advised at about the 3rd day
• A consultation with a member of the multidisciplinary team is recommended every 4 to 6 weeks
• Prescription of medicines: This is the responsibility of the practitioner.

Short term (the first 8 days)

• Anti-nausea drugs such as metoclopramide, either long-acting or to be taken twice daily
• As required, digestive anti-spasmodic such as tiemonium methyl sulphate 50mg.

Long term (during the 6 months)

• Proton pump inhibitor (PPI) gastric anti-secretory agent, full dose taken daily (e.g. Lansoprazole 30mg/d)

Important: Do not prescribe food supplements or their equivalent containing enzymes of biological origin.

Restriction of activity: It is strictly forbidden for the patient to dive or to fly in an unpressurised aircraft (if the balloon is filled with air).  Combat and extreme sports are definitely not recommended.

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 respirator
• By professionals having received specific training in a referral center already practicing these procedures.

After the extraction procedure:

• An endoscopic examination to check there is no gastric or esophageal lesion is necessary.
• The patient is seen about the 15th day by a member of the multidisciplinary team. After that the follow-up must be multidisciplinary according to the methods defined in the recommendations for the treatment of the obese adult.

Preparation, release & extraction of the intra-gastric balloon

• Refer to the User’s Manual attached to this leaflet

This non-sterile, single use device is made up of:

1. An intra-gastric balloon system ENDT110

• An intra-gastric balloon (radio-opaque), a single pouch (air and liquid) in polyurethane pre-connected to the introduction system
• An introduction system

2. Accessories (separate packaging)

• 1 x 50 ml sterile, single use syringe
• A filling kit ENDAC01 single use
• 1 single use extraction kit ENDAC03 composed of:
• 1 hollow drainage needle (sclerosis type), PUNC- reference AS264106
• 1 universal bi-conical connector for the connection between the drainage needle and the aspiration ENDAC02
• 1 pair of extraction forceps (with hooks), VIPER – reference AS2290718

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 deployment and extraction of the balloon: Damage to the pharynx or oesophagus, Damage to the stomach wall, Perforation of the oesophagus, duodenum, ostium cardiacum or stomach wall if the balloon is in the wrong place when it is inflated.

Mechanical complications caused by the balloon:

The weight of the liquid-filled balloon can act on ulcers in the stomach wall to cause frank perforation, a life-threatening situation that requires emergency surgery. The digestive tract can become obstructed as a result of migration of an insufficiently inflated or partially deflated balloon; obstruction of the gut is possible as is gastric obstruction if the balloon gets lodged in the pyloric antrum: this will sometimes require surgical repair. Such complications are far more likely if the maximum time frame of six months is exceeded. The literature reports a risk of spontaneous hyperinflation due to the generation of gas inside the balloon.Acute pancreatitis is possible if the balloon exerts mechanical pressure on the organ across the stomach wall.

Functional complications (side effects)
Insertion of an intra-gastric balloon is sometimes accompanied in the early days by gastric heaviness, and nausea and vomiting which normally recede in 2 to 7 days.  Symptoms of gastro-esophageal reflux are also possible.  These problems can be corrected by appropriate treatment with drugs (anti-secretory medication, anti-nausea drugs).  Vomiting may persist necessitating premature removal of the balloon.

Metabolic complications
These result from uncontrolled or neglected vomiting which can be the cause of dehydration, metabolic alkalosis, hypocalcaemia, and functional renal failure.  Hypocalcaemia can be responsible for serious cardiac rhythm disorders with a risk to life.

Failures
Absence or a refusal of dietary treatment concomitant with the insertion of an intra-gastric balloon compromises the results as far as weight loss is concerned.  Similarly, the risk of regaining weight after the removal of the intra-gastric balloon is even more likely if the obesity is longstanding and serious.