Indications For Use - GI Dynamics EndoBarrier Instrucciones De Uso

Retrieval System
The EndoBarrier GI liner is designed to be removed using
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the EndoBarrier Gastrointestinal Liner Retrieval System.
A separate Instructions for Use is available for the retrieval
system.

Indications for Use

The GI Dynamics' EndoBarrier
System is used for the treatment of obese type 2 diabetes
with BMI ≥ 30 kg/m 2 , or obese patients with BMI ≥ 30 kg/m
with ≥ 1 co-morbidities, or obese patients with
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BMI > 35 kg/m . The GI liner is indicated for a maximum
implant duration of 12 months.
Contraindications
The EndoBarrier GI liner is contraindicated in patients with
the following:

Women who are pregnant

Requirement for prescription anticoagulation therapy

History of inflammatory bowel disease or condition of
the gastrointestinal tract, such as PUD, ulcers, or
Crohn's disease

Pancreatitis

Uncontrolled GERD

Known infection at the time of implant

Symptomatic coronary artery disease or pulmonary
dysfunction

History of coagulopathy

Bleeding diathesis, upper gastro-intestinal bleeding
conditions such as esophageal or gastric varices, or
congenital or acquired intestinal telangiectasia

Congenital or acquired anomalies of the GI tract such
as atresias or stenoses

Previous GI surgery that could affect the ability to
place the GI liner or its function

Iron deficiency and/or iron deficiency anemia

Active symptoms of kidney stones or known presence
of gallstones

Inability to discontinue use of non-steroidal anti-
inflammatory drugs (NSAIDs) during the implant
period

Family or patient history of known diagnosis or pre-
existing condition of systemic lupus erythematosus,
scleroderma, or other autoimmune connective tissue
disorder

H. pylori positive status (Patients may receive the GI
liner if they had a prior history and were successfully
treated.)
Warnings

Only physicians trained in therapeutic endoscopic
techniques should use this product.

Physicians attempting to recover a migrated GI liner
should be limited to those who have completed
appropriate EndoBarrier retrieval technique training.
Devices that have migrated more than 3 cm or have
rotated should be removed.

If the patient exhibits any signs of bleeding that could
be related to the device, it is recommended that the GI
liner be removed.
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Gastrointestinal Liner
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
Physicians must be prepared to deal with urgent
requirements to remove a GI liner that results in duct
or GI liner obstruction.

Do not withdraw the GI liner through the alimentary
tract unless it has been adequately covered by the
EndoBarrier Gastrointestinal Retrieval System
Retrieval Hood component placed on the distal end of
the gastroscope. A liner's anchor that is not adequately
covered could damage tissue.

Remove the gastroscope before removing the outer
catheter of the Delivery System; both will not fit in the
esophagus. Never allow the outer catheter and capsule
to enter the esophagus if the gastroscope is in place as
this may lead to perforation.

Do not attempt to repair or reuse a damaged product,
return to manufacturer. Do not reuse or re-sterilize this
product. Reuse of this product could cause liner failure
or pose a contamination issue.
EndoBarrier Gastrointestinal Liner
Precautions
Handling precautions

Inspect the Delivery System before use to determine
that the tracking ball at the tip of the catheter has not
separated from the catheter. If it has, gently push the
ball back into the capsule.

Do not modify the system. Modifications could
damage the system, resulting in failure to release the
GI liner, premature release of the tracking ball, and
improper seating of the GI liner in the proximal
duodenum.
Pre-procedural precautions

Patients must receive a proton pump inhibitor (40 mg
omeprazole twice a day or equivalent) for three (3)
days prior to the procedure and should continue the
medication until two (2) weeks after the GI liner is
removed.

Patients should not take anticoagulants (aspirin,
heparin, NSAIDs, etc.) for 10 days prior to GI liner
placement and for the duration of treatment.

To reduce the potential for infection, a single
2-gram dose of ceftriaxone (or equivalent) should be
administered intravenously 1-2 hours prior to GI liner
placement. Individuals with known allergies or
hypersensitivity to ceftriaxone, cephalosporins or
penicillins should seek an equivalent, long acting ,
broad spectrum antibiotic. Please see antibiotic
package insert for full prescribing information and
details.
Procedural precautions

The ability of the patient to remain still during the
procedure must be considered when determining the
method of sedation. The type of sedation selected is
left to physician judgment. Conscious sedation has not
been fully evaluated in a clinical setting.

A thorough gastroscopic examination of the stomach,
pylorus and duodenum should be performed prior to
GI liner placement to ensure that the patient's
alimentary canal is free of abnormalities which could
interfere with the delivery, function and removal of
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