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space for the endoscope to be reinserted for observing the
IGB filling steps.
12.2 IGB FILLING
Using aseptic technique, place the Fill Kit spike into the
sterile saline bag. Attach a sterile syringe to the valve of the
Fill Kit and prime it. Connect the Luer-Lock connector on the
Placement Catheter to the Fill Kit valve. Proceed to deploy
the IGB, verifying with the endoscope that the IGB is within
the stomach.
CAUTION: Fill the IGB with sterile saline. An aseptic
technique, similar to changing IV fluids (e.g. use of clean or
sterile gloves, sterile syringe, etc.), is recommended.
Though the cause of hyperinflation is unknown, it may be
caused by fungal or bacterial microbes contaminating the
balloon. One recommended
contaminating the
microorganisms that
hyperinflation.
CAUTION: During the filling process the Placement
Catheter must remain slack. If the catheter is under tension
during this process, the tip of the catheter may dislodge from
the IGB, preventing further IGB deployment.
WARNING: Rapid fill rates will generate high pressure
which can damage the IGB valve or cause premature
detachment from the tip of the Placement Catheter.
12.2.1. Filling Recommendations
The expandable design of the IGB permits a fill volume
range of 400cc (minimum) to a maximum of 700cc. The
IGB should not be under-filled or over-filled with volumes
<400cc or >700cc, as under- or over-filling the IGB could
cause higher risk for serious side effects, such as
migration (under-filled IGB) or gastric rupture/perforation
(over-filled IGB). Once filled, the IGB is not adjustable.
To determine ideal IGB size to produce the greatest weight
loss effectiveness, two (2) independent reviewers
searched PubMed and Embase to identify full-length IGB
clinical studies. A total of 80 studies with 8,506 patients
were included in this meta-analysis of global data. Figure
4, meta-regression analysis of IGB fill volume correlation
with total body weight loss (TBWL), demonstrates fill
volume ranges from 500cc to 700cc. Results at 6 months
do not seem to differ with volume (p=0.24).
based on this, the recommendation should be filling
volume between 500cc to 650cc; however the pivotal
clinical study's safety and effectiveness data for this
device was only tested with fill volumes of 550cc ± 50cc.
Figure 5: Meta-regression analysis of IGB fill volume correlation
with total body weight loss (TBWL).
Note: the size of the circles on the graph corresponds with the study size. Figure courtesy
of Dr. Barham Abu-Dayyeh.
mitigation is
saline within the balloon
may lead to spontaneous
1 Therefore,
1
The following filling recommendations are provided to
avoid inadvertent damage to the valve of the balloon or
premature detachment from the Placement Catheter:
•
•
•
WARNING: Rapid fill rates will generate high pressure
which can damage the IGB valve or cause premature
to avoid
detachment from the tip of the Placement Catheter.
with
•
•
Note: Any IGB that leaks should be returned to Apollo
Endosurgery with a completed product return field note
describing the event. Your assistance with our continuing
quality improvement efforts is appreciated.
A minimum fill volume of 400cc is required for the IGB to
deploy completely from the Placement Catheter. After
filling the IGB, remove the Fill Kit from the catheter.
When filled, the IGB is released by pulling the Placement
Catheter gently while the IGB is against the tip of the
endoscope or the lower esophageal sphincter.
Continue to pull the Placement Catheter until it has
detached from the IGB's self-sealing valve. Once
detached, the placement of the IGB should be visually
inspected as well as for the presence of any fluid leaks.
12.3 IGB PLACEMENT AND FILLING (STEP-BY-STEP)
1. Prepare the patient according to hospital protocol for
sedation and endoscopy.
2. Perform endoscopic inspection of the esophagus and
stomach.
3. Remove endoscope.
4. If there are no contraindications:
a. Lubricate the sheath of the Placement Catheter
b. Gently insert the Placement Catheter into the
5. Reinsert the endoscope while the IGB is in situ to observe
filling steps. The IGB MUST be below the lower
esophageal sphincter and well within the stomach cavity.
8
IGB Fill Volume at 6 months
Always use the IGB Fill Kit provided.
Always use a sterile 50cc syringe to fill the IGB. Use
of smaller syringes can result in very high pressures
of 30, 40, and even 50 psi, which can damage the IGB
valve.
With a sterile 50cc syringe, each filling stroke should
be done slowly (minimum of 10 seconds) and
steadily. Slow, steady filling will avoid the generation
of high pressure to the valve.
Filling should always be completed under direct
visualization (gastroscopy). Integrity of the IGB valve
should be confirmed by observing the valve lumen as
the Placement Catheter is removed from valve of the
IGB.
An IGB with a leaking valve must be removed
immediately. A partially filled IGB can result in a bowel
obstruction, which can result in death. Bowel
obstructions have occurred
unrecognized or untreated IGB
collapse).
assembly with surgical lube-gel.
esophagus and into the stomach.
as a result of
deflation (i.e.