Product Specifications - apollo endosurgery ORBERA Guia Del Usuario

The ORBERA 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.
The maximum placement period for the ORBERA System is
6 months, and it must be removed at that time or earlier.
5.

PRODUCT SPECIFICATIONS

ORBERA System, Reference No. B-50000 (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: Silicone
Guidewire: PTFE coated stainless-
steel
Placement
Catheter Tip: Polypropylene
Catheter
Assembly
Sheath: Silicone elastomer and
Silicone adhesive/primer coated in
Sodium Bicarbonate
6. CONTRAINDICATIONS
Contraindications for use of the IGB System include:
The presence of more than one IGB at the same time.
•
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
Materials
severe or intractable
o Acute liver failure and advanced cirrhosis with
o Large esophageal varices with red color signs and
o Severe portal hypertensive gastropathy with or
• 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
markings) is necessary to allow proper filling. Lodging
of the IGB in the esophageal opening during filling may
cause serious injury. Failure to confirm proper
positioning may cause injury to the esophagus,
duodenum, or pylorus.
When filling the IGB during the placement procedure,
•
avoid rapid fill rates as these will generate high pressure
which can damage the IGB valve or cause premature
detachment of the IGB from the tip of the placement
catheter.
Each patient must be monitored closely during the
•
entire term of treatment in order to detect the
development of possible adverse events. Each patient
should be instructed regarding symptoms of deflation,
gastrointestinal obstruction, acute pancreatitis, IGB
inflation
hyperinflation), ulceration, gastric and esophageal
gastro-
perforation, and other adverse events which might
occur, and should be advised to contact his/her
physician immediately upon the onset of such
symptoms. Patients need to be evaluated and the
device removed at or within 6 months of placement.
Patients must be advised that the IGB is intended to be
•
placed for 6 months maximally, at which point removal
is required. Longer periods of IGB placement increase
the risk of IGB deflation (a reduction in size of the device
due to loss of saline) which can lead to intestinal
obstruction and risk for death. The risk of these events
4
encephalopathy muscle wasting and anasarca
gastric varices.
without gastric antral vascular ectasia
after placement (i.e. spontaneous