Indications For Use - Allurion Elipse Mode D'emploi

so that, if necessary, it may be used to assist the patient
in swallowing the device. The Stylet can be removed from
the Delivery Catheter by unfastening the connector and
pulling the Stylet out.
Figure 5: Elipse™ Practice Capsule
The Elipse Practice Capsule (Figure 5) is a vegetarian,
non-animal derived, degradable capsule that is approximately
the same size and weight as the Elipse Device. The Practice
Capsule may be offered as an option to the patient before the
Elipse Device is administered to familiarize the patient with
the swallowing experience.
Figure 6: Pressure Infusor
The Pressure Infusor (Figure 6) manufactured by Merit Medical
can be re-used per the manufacturer's instructions for use.
The Filler Bag slides inside the Pressure Infusor and is
hung on a hook prior to pressurization. The Pressure Infusor
includes a White Stopcock that can be turned to deflate
the Infusor.

Indications for Use

The indications for use of the Elipse Gastric Balloon
System are to promote temporary weight loss in overweight
and obese individuals with a body mass index (BMI) of
≥ 27.0 kg/m . The Elipse Gastric Balloon System is to be
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used in conjunction with a supervised nutrition program.
Expected Weight Loss
Clinical evaluation of the Elipse Device suggests that on
average, patients will lose approximately 10-15% of their
starting total body weight. Individual results vary widely.
Contraindications
Difficulty swallowing (dysphagia):
Any abnormal swallowing mechanism from an
■
esophageal motility disorder such as achalasia,
scleroderma, or diffuse esophageal spasm
Any structural esophageal abnormality such as a web,
■
stricture, diverticulum, or large hiatal hernia
Conditions that predispose to bowel obstruction:
History of perforated appendicitis
■
History of three or more caesarean deliveries
■
History of abdominal or pelvic surgery excluding any single
■
one, but no more than one, of the following surgeries that
was performed at least 12 months prior to Elipse treatment:
diagnostic laparoscopy, laparoscopic appendectomy,
Pressure
Infuser
Inflation
Bulb
Pressure
Regulator
White
Stopcock
open appendectomy with a right lower quadrant incision
(midline incision is contraindicated), laparoscopic
cholecystectomy
Inflammatory Bowel Disease (Crohn's Disease and
■
Ulcerative Colitis)
Severe GI motility disorder such as severe gastroparesis
■
GI bleeding or conditions that predispose to GI bleeding:
Inflammatory conditions such as esophagitis, gastritis,
■
gastric ulceration, or duodenal ulceration
Vascular lesions such as esophageal varices, gastric or
■
duodenal varices, or intestinal telangiectasias
Benign or malignant gastrointestinal tumors
■
Inability to discontinue use of non-steroidal anti-
■
inflammatory drugs (NSAIDs) or other gastric irritants
during the device period
Patients receiving anticoagulants
■
Severe coagulopathy
■
Hepatic insufficiency or cirrhosis
■
Inability or unwillingness to take prescribed antiemetic
■
medications in preparation for and/or during device
residence
Other conditions:
Serious or uncontrolled psychiatric illness
■
Diagnosed bulimia, binge eating, compulsive overeating,
■
or similar eating-related psychological disorders
Alcoholism or drug addiction
■
Pancreatitis
■
Symptomatic congestive heart failure, cardiac arrhythmia,
■
or unstable coronary artery disease
Pre-existing respiratory disease such as chronic
■
obstructive pulmonary disease (COPD), obesity
hypoventilation syndrome, Cystic fibrosis or cancer
Known or suspected allergies to polyurethane or silicone
■
Inability or unwillingness to take prescribed proton pump
■
inhibitor medications in preparation for and/or during
device residence
Women who are pregnant or nursing
■
Children 18 years or younger
■
Individuals 65 years or older
■
Individuals who are immunocompromised
■
Autoimmune disorders (e.g. lupus, scleroderma)
■
An existing gastric balloon that is currently in the stomach
■
Complications
The Elipse Gastric Balloon System must only be used
by qualified physicians for the indicated use. Potential
complications include, but are not limited to the following:
Insufficient or no weight loss
■
Adverse health consequences resulting from weight loss
■
Nausea and/or vomiting
■
Chest pain, heartburn or GERD
■
Esophagitis or esophageal ulcer
■
Abdominal distention with or without discomfort
■
Abdominal pain
■
Gastric or duodenal ulcers
■
Mallory-Weiss tear
■
Mucosal laceration
■
GI bleeding
■
Difficulty breathing
■
Dehydration
■
Diarrhea
■
Constipation
■
Fatigue
■
Infection
■
Allergic reaction
■
Adverse tissue reaction
■
Pancreatitis
■
Aspiration, aspiration pneumonia
■
Esophageal, gastric, intestinal or other organ trauma
■
or perforation
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