Device Description - apollo endosurgery ORBERA365 Manual Del Usuario

1. INTRODUCTION
ORBERA365 Intragastric Balloon (IGB) System
(Ref. No. B-50012)
The information below is generalized. Each patient must be
individually evaluated for the ORBERA365 Intragastric
Balloon (referred to as IGB throughout this document)
treatment based on the medical judgment of a qualified
bariatric medical team.
Each physician and patient should evaluate the risks
associated with endoscopy and IGBs and the possible
benefits of a temporary treatment for weight loss prior to use
of the IGB.
Physicians placing an IGB must fulfill the following
requirements:
Advanced upper endoscopy skill and experience
•
evidenced by possession of Interventional Endoscopy
privileges granted locally by the participating hospital or
ambulatory facility.
• Completion of an Apollo Endosurgery sponsored or
authorized comprehensive IGB training program.
Clinical use of the IGB to make it a component of a
•
multidisciplinary weight management practice which
provides long-term support and follow-up.
• Have a comprehensive
management patient support program that includes
appropriate endoscopy facilities, nutrition and exercise
counseling, psychological, general medicine, and
radiological support personnel.
Able to have in-service training for support staff by
•
Apollo Endosurgery trained product specialists.
2. INFORMATION THAT SHOULD BE PROVIDED TO THE
PATIENT
IGB placement is an elective procedure and the patient must
be well counseled on the risk-benefit relationship. The
physician must inform the patient of the warnings,
precautions, and adverse events listed in this document.
The physician should also advise the patient that early
removal of the balloon may be required if serious adverse
reactions occur.
3.

DEVICE DESCRIPTION

The ORBERA365 Intragastric Balloon (IGB) System (Figure
1) is designed to assist weight loss by partially filling the
stomach.
Figure 1: The ORBERA365 Intragastric Balloon
(IGB)System filled to 400cc and 700cc with uninflated
system in the foreground
ORBERA365 Intragastric Balloon System
therapeutic weight
The IGB is placed in the stomach and filled with sterile
saline, causing it to expand into a spherical shape (Figure
2). The filled IGB is designed to occupy space and move
freely within the stomach. The expandable design of the IGB
permits a fill volume range of 400cc (minimum) to a
maximum of 700cc (refer to the "Filling Recommendations"
section). Once filled, the IGB volume is not adjustable. A
self-sealing valve permits detachment from a Placement
Catheter (see the "Directions for Use" Section).
Figure 2: Saline-filled IGB in the stomach
The IGB is positioned within the "Placement Catheter
Assembly" (Figure 3) which consists of a 6.5 mm external-
diameter catheter with length markers provided as a
reference. One end of the catheter is connected to a sheath
which houses the collapsed IGB and the opposite end has a
Luer lock connector which allows the catheter to be attached
to the "Fill Kit". The tubing of the placement catheter is made
of either silicone or polyurethane. Silicone catheters have a
stainless-steel guidewire inserted into the catheter tubing for
increased rigidity during placement. A guidewire is not
present within polyurethane catheters as the rigidity of the
material makes a guidewire unnecessary.
A "Fill Kit", consisting of an IV spike, fill tube and filling valve,
is also provided to assist with the IGB filling process (Figure
4).
Figure 3: Placement Catheter Assembly (i.e. Sheath
Figure 4: Fill Kit with IV Spike
3
Assembly)