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The ORBERA® Intragastric Balloon System (English)
INTRODUCTION
ORBERA® Intragastric Balloon System
(Ref. No. B-50000)
Figure 1. The ORBERA® Intragastric Balloon System
filled to 400 cc and 700 cc with uninflated system in
the foreground
The ORBERA® Intragastric Balloon System (Fig. 1) is designed
to assist weight loss by partially filling the stomach and
inducing satiety. The ORBERA® System balloon is placed in
the stomach and filled with saline, causing it to expand into
a spherical shape (Fig. 2). The filled balloon is designed to act
as an artificial bezoar and move freely within the stomach.
The expandable design of the ORBERA® System balloon
permits fill volume adjustment at the time of placement
from 400 cc to 700 cc. A self-sealing valve permits
detachment from external catheters.
Figure 2. Inflated balloon in the stomach
In the ORBERA® System, the ORBERA® System balloon is
positioned within the Placement Catheter Assembly. The
Placement Catheter Assembly (Fig. 3) consists of a 6.5 mm
external-diameter silicone catheter, one end of which is
connected to a sheath in which the collapsed balloon resides.
The opposite end is connected to a Luer lock connector for
attachment to a filling system. Length markers are provided
as a reference on the fill tube. A guide wire is inserted into the
silicone catheter for increased rigidity.
A filling system consisting of an IV spike, fill tube and filling
valve is provided to assist in the balloon deployment.
Figure 3. Placement Catheter Assembly
Note: Practitioners should be proficient in general
endoscopic skills. Training by Apollo Endosurgery
education/field experts in placement and removal of the
device is available through your Orbera representative. To
receive additional information, please contact your local
Orbera representative.
INDICATIONS FOR USE
The ORBERA® System is indicated for temporary use in
weight-loss therapy for overweight patients with a Body
Mass Index (BMI) 27 kg/m
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.
CAUTION: The risk of balloon deflation and intestinal
obstruction (and therefore possible death related to
intestinal obstruction) is significantly higher when
balloons are left in place longer than 6 months. This
has already been experienced.
Each physician and patient should evaluate the risks
associated with endoscopy and intragastric balloons
(see complications below) and the possible benefits of a
temporary treatment for weight loss prior to use of the
ORBERA® System.
CAUTION: Temporary weight-loss treatments have
been shown to have poor long-term success rates in
obese and severely obese patients. Patients need
to be evaluated and the device removed or replaced
every 180 days. Clinical data does not currently exist
to support use of an individual ORBERA® System
balloon beyond 180 days.
Physicians have reported the concurrent use of
medications which reduce acid formation or reduce
acidity. Silicone elastomer is degraded by acid.
Moderating the pH in the stomach should prolong the
integrity of the ORBERA® System.
The materials used to fabricate this device have been
tested according to ISO 10993, the International Standard
for biological evaluation of medical devices.
WARNINGS AND PRECAUTIONS
The risk of balloon deflation and intestinal obstruction
(and therefore possible death related to intestinal
obstruction) is significantly higher when balloons are left
in place longer than 6 months or used at larger volumes
(greater than 700 cc).
Deflated devices should be removed promptly.
A patient whose deflated balloon has moved into the
intestines must be monitored closely for an appropriate
period of time to confirm its uneventful passage through
the intestine.
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or greater.
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