Device Description - Allurion Elipse Mode D'emploi

Introduction
The Elipse Device is a gastric balloon that promotes
temporary weight loss in overweight and obese individuals.
While weight loss may benefit patients treated with the
Elipse Device, use of the Elipse Device also carries risks.
Each physician and patient should carefully evaluate both
the risks and benefits of treatment prior to use of the
Elipse Device.
Physicians placing the Elipse Device must:
Provide the patient with access to an endoscopy facility
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should intervention be required to puncture or remove
the device.
Provide the patient with access to a supervised
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nutrition program.
Be thoroughly familiar with and/or trained on the use
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of Intragastric Balloons before placing the device.
Communicating Risks and Benefits to the Patient
It is essential to inform potential patients about the benefits
and risks of gastric balloons and the Elipse Device prior
to treatment. The physician must communicate all contra-
indications, precautions, warnings, and complications listed
in these instructions. The physician must make it clear to the
patient that treatment with a gastric balloon may result in
complications and that severe complications have resulted
in interventions, including both endoscopic and surgical
interventions, to puncture or remove the device. Complications
may occur at any time during treatment and physicians
should encourage patients to maintain access to modern
emergency healthcare facilities during Elipse Device
treatment should serious complications occur.

Device Description

The principal component of the Elipse Gastric Balloon
System is the Elipse Device (Figure 1).
Connector
Capsule
Delivery
Catheter
Figure 1: Elipse™ Device
The Elipse Device is a gastric balloon (also known as an
intragastric balloon or IGB) that is enclosed in a Capsule
and is swallowed by the patient to introduce the Device into
the stomach. During swallowing, the Device Delivery Catheter
remains outside of the patient's mouth to permit filling.
Once the Device position has been confirmed to be in the
stomach, the Balloon can be filled with the provided Filler Kit.
After filling, the Delivery Catheter is removed from the Device
by gently pulling back.
The filled Elipse Device is designed to remain in the stomach
for approximately 16 weeks. During this time, the Device
operates in the same ways as other IGBs to promote satiety
and reduce food consumption. At the end of the treatment
period, the Device is designed to automatically open and
drain. At this point, the empty Device is designed to transit
the gastrointestinal tract and be excreted without further
intervention. In some cases, the drained device may exit the
stomach via emesis.
The Elipse Gastric Balloon System is comprised of the
Elipse Device (Figure 1) which becomes the Elipse Balloon
(Figure 2) when filled, the Elipse Filler Kit (Figure 3),
the Elipse Stylet (Figure 4), and the Elipse Practice
Capsule (Figure 5). All devices are supplied non-sterile and
for single use only. The Elipse Gastric Balloon System has
been tested in conjunction with the Merit Medical 500 ml
PIB500 Pressure Infusor Bag (Pressure Infusor, Figure 6),
which is to be used to aid in filling the Elipse Device and
can be re-used if maintained per the manufacturer's
instructions for use.
The Elipse Device (Figure 1) is comprised of the
following items:
Balloon (Figure 2) constructed from polymers forming
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a thin film. The inflated residence time in the stomach
is designed to be 16 weeks but may vary from patient
to patient.
Release
Valve
Figure 2: Elipse™ Balloon
Capsule composed of a vegetarian, non-animal derived,
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degradable material that encloses the Balloon.
Delivery Catheter with proximal connector, radiopaque
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shaft, and shaft length markings.
Filler Bag
Filling Fluid
Septum Port
Spike & Flow
Indicator
Blue Stopcock
& Connector
Extension Hose
Figure 3: Elipse™ Filler Kit
The Elipse Filler Kit (Figure 3) is comprised of the
following items:
Filler Bag containing Filling Fluid, consisting of 560 ml of
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distilled water containing the food preservative potassium
sorbate and citric acid, and a Septum Port to connect
to the Extension Hose.
Extension Hose with a Flow Indicator, a Spike to pierce
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the Filler Bag Septum Port and a Blue Stopcock to
connect to the Delivery Catheter.
A Syringe that, if needed, can be connected to the
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Delivery Catheter and used to evacuate the Balloon
in an emergency.
Connector
Stylet Shaft
Figure 4: Elipse™ Stylet
The Elipse Stylet (Figure 4) is comprised of a guidewire
with attached connector that interfaces with the Delivery
Catheter. The Stylet can be passed through and connected
to the Delivery Catheter to stiffen the Delivery Catheter
1
Fill Valve
Syringe