Indications For Use; Product Specifications; Contraindications - apollo endosurgery BIB Bedienungsanleitung

4.

INDICATIONS FOR USE

The BIB System is indicated for temporary use in weight-
loss therapy for obese adult patients (18 years of age or
older) who have significant health risks related to their
obesity and who have failed to achieve and maintain weight
loss with a supervised weight-control program (see specific
indications below).
The BIB System is indicated for:
• Pre-surgical temporary use for weight loss in obese
patients (BMI 40 and above or a BMI of 35 or above with
comorbidities) prior to obesity or other surgery, in order
to reduce surgical risk.
Temporary use for weight loss in obese patients (BMI
•
30-39) who have significant health risks related to their
obesity and who have failed to achieve and maintain
weight loss with a supervised weight-control program.
The BIB System is to be used in conjunction with a long-
term supervised diet and behavior modification program
designed to increase the possibility of long-term weight-
loss maintenance.
Temporary use for weight loss in obese patients (BMI
•
40 or above, or BMI 35 or above with comorbidities)
who are not candidates for obesity surgery, in
conjunction with a long-term supervised diet and
behavior modification program designed to increase the
possibility of long-term weight-loss maintenance.
The maximum placement period for the BIB System is 6
months, and it must be removed at that time or earlier.
5.

PRODUCT SPECIFICATIONS

• BIB System, Reference No. B-40800 (IGB positioned in
a Placement Catheter Assembly (i.e. sheath assembly))
The IGB System contains no latex or natural rubber
•
materials.
The products are supplied clean, non-sterile and
•
packaged for single use.
The materials used to fabricate this device (see Table
•
1) have been tested according to ISO 10993, the
international Standard for biological evaluation of
medical devices.
Table 1: IGB Product Materials
System
Component
Silicone elastomer components coated in
IGB
Sodium Bicarbonate
Tubing:
•
•
Placement
Catheter
Assembly
Catheter Tip: Polypropylene
Sheath: Silicone elastomer and Silicone
adhesive/primer
Bicarbonate
6.

CONTRAINDICATIONS

Contraindications for use of the IGB System include:
The presence of more than one IGB at the same time.
•
Use of the IGB is contraindicated for weight loss for
•
cosmetic reasons only.
Materials
Silicone (assemblies with a PTFE
coated stainless-steel guidewire)
Polyurethane (assemblies without a
PTFE coated stainless-steel
guidewire)
coated in Sodium
Use of the IGB System is contraindicated for weight loss
•
in patients with a BMI less than 30, unless accompanied
by comorbidities associated with obesity that would be
expected to improve with weight loss.
Prior surgery involving the esophagus, stomach, and
•
duodenum or bariatric surgery.
Any inflammatory disease of the gastrointestinal tract
•
including esophagitis, gastric ulceration, duodenal
ulceration, cancer or specific inflammation such as
Crohn's disease.
Potential upper gastrointestinal bleeding conditions
•
such as esophageal or gastric varices, congenital or
acquired intestinal telangiectasis, or other congenital
anomalies of the gastrointestinal tract such as atresias
or stenoses.
A large hiatal hernia of > 5cm or a hernia ≤ 5 cm
•
associated with
esophageal reflux symptoms.
• A structural abnormality in the esophagus or pharynx
such as a stricture or diverticulum that could impede
passage of the delivery catheter and/or an endoscope.
Achalasia, symptoms suggestive of delayed gastric
•
emptying, or presence of any other severe motility
disorder that that may pose a safety risk during
placement or removal of the device.
• Gastric Mass.
Severe coagulopathy.
•
Hepatic insufficiency or cirrhosis involving
•
o Acute liver failure and advanced cirrhosis with
encephalopathy muscle wasting and anasarca
o Large esophageal varices with red color signs and
gastric varices.
o Severe portal hypertensive gastropathy with or
without gastric antral vascular ectasia
Patients who are known to have or suspected to have
•
an allergic reaction to materials contained in the IGB.
Any other medical condition that would not permit
•
elective endoscopy such as poor general health or
history and/or symptoms of severe renal, hepatic,
cardiac, and/or pulmonary disease.
Serious or uncontrolled psychiatric illness or disorder
•
that could compromise patient understanding of or
compliance with follow up visits and removal of the
device after 6 months.
• Alcoholism or drug addiction.
Patients who are unable or unwilling to take prescribed
•
proton pump inhibitor medication for the duration of the
device implant.
• Patients unwilling to participate in an established
medically supervised diet and behavior modification
program, with routine medical follow-up.
Patients receiving aspirin, anti-inflammatory agents,
•
anticoagulants or other gastric irritants, not under
medical supervision.
• Patients who are known to be pregnant or breast-
feeding.
7. WARNINGS
• Proper positioning of the Placement Catheter Assembly
and the IGB within the stomach (using measured
distance from the incisors via the insertion tube
4
severe or intractable gastro-