This is the first minimally invasive option available for people who are not excessively obese and have been unsuccessful with traditional dieting, exercise, and behavioral modification. Learn how this device can help incentivize you to adopt a healthy lifestyle that will have a tremendous impact on your overall physical and mental wellbeing.

1. Intragastric Balloon System
For Weight Management
Presented by:
Hazar Michael, MD
J. Scott Gillin, MD, FACP
May 31, 2017

2. Disclosure
Some of slides are provided by Apollo
Company, the manufacturer of Orbera
Intragastric Balloon. These slides are
clearly marked on the right bottom corner
of each of the slide.

3. Background
• Currently we use BMI (Body Mass Index)
system to access our weight status
 It takes into account weight and height
 Underweight <20
 Normal Weight 20-25
 Overweight 25-30
 Obesity >30
• Stage 1 30-35
• Stage 2 35-40
• Stage 3 >40 (morbid Obesity)

4. Obesity Background
• According to NIH in 2003-2004
 61% of USA adult are obese or overweight
 32.2% are Frankly obese
• Newer data suggests 38% of kids over age 15 and adult
are obese
• USA is the most obese nation worldwide
 4.8% are morbidly obese
• Obesity is a potentially serious medical illness
and not a cosmetic condition
• Obesity is associated with metabolic syndrome
and its complications
 Increased abdominal fat, diabetes, abnormal lipid,
heart disease, fatty liver and liver cirrhosis, etc.

5. Obesity Background (cont.)
• Many patients try to lose weight but
many fail and/or relapse
• Only 3-5% of those who lose weight by
diet can maintain the weight loss for 5
years
• Medication can enhance weight loss but
it remains of limited efficacy

9. Background
• Bariatric surgery results in durable and significant weight loss
• Bariatric surgery is indicated
 Morbid Obesity (BMI 40)
 Stage 2 obesity (BMI 35-39.9) with complications
• Large portion of population are not candidate for bariatric surgery
under current recommendation or insurance coverage
• Obesity is a disease and earlier intervention is more effective
 Easier to change habit
 Less emotional and health impact on affected person and society
• Rate of bariatric surgery is increasing
 13,365 in 2003 to 220,000 in 2009 in USA and Canada
• It is estimated that only about 1% of affected patient with Obesity are undergoing
bariatric surgery

10. Background
• Surgery had evolved to be less risky, more tailored
to patient needs and had proven health benefit
• RYGB lead to average 56.7% to 66.5% Excess Weight Loss
(EWL) during 24 months after surgery
– Improved or resolved diseases found in 86% of diabetes, 68%
hypertension, 81% obstructive sleep apneas and 97%
hyperlipidemia
– Proven to have survival benefit
– Had potential serious immediate and late complication and alter
anatomy
– If not adherant to healthy habit many patient gain weight back
• Gastric sleeve is a newer surgery indicated for lower BMI
than RYGB and comparing to RYGB
– No major anatomical alternation
– Safer than except risk of leak
– Less effective

12. Background
• To bridge the gap we need effective and
less invasive intervention
 Evolving multiple endoscopic techniques
• Non surgical
• Less Invasive and anatomy altering
• Cash payment only, no insurance coverage yet
• Variety of techniques, most acceptable in clinical
practice
– Intragastric Balloon System
– Endoscopic Gastroplasty to mimic sleeve gastrectomy

13. Endoscopic Sleeve Gastroplasty
• Reducing the size of the
stomach by a series of
endoscopic full thickness
suture
• Learning curve to use the
device and master the
techniques
• Effective at 6 months, 30-
40% excess body weight
loss
• More data and longer
follow up needed

14. Weight Loss Intragastric Balloon
• 2 FDA approved devices in USA
• Worldwide more experience with
the Orbera Balloon
Orbera

15. Orbera Intragastric Balloon
• At least 220,000 cases world wide
• Approved for 6 months balloon placement
 There is a movement toward a year approval
• Both placement and removal done via
endoscopy no need for incision
 Placement is easy and takes about 15-30 minute
under standard anesthesia for endoscopic
procedure
 Removal more challenging, better under general
anesthesia to protect the lung from aspiration

16. Orbera Intragastric Balloon
• Indication
 FDA approved for BMI 30-40
 Cash bundle payment
 Bariatric surgery more effective in BMI>40
• Contraindication to placement
 Anatomical barrier to remove or increased risk of local
complication
• HH>5 cm, or intractable GERD, Stricture, achalasia
– Prior gastric surgery . 5/3824 perforation in Italian study, 4/5 had
prior gastric surgery (including fundoplication or prior bariatric
procedure)
 Bleeding/ulceration risk
– Coagulopathy, bleeding condition ,anticoagulant, intolerance or
unwilling to take PPI for the duration of placement

17. Orbera Intragastric Balloon
• USA data
 273 patients were randomized to Orbera plus
behavioral modification (BM) vs BM alone, fu 12
months, mean BMI 35.2
• Mean EWL was 38% at 6 months and 26.5% at 9 months
• TBWL 10.2%
• At least 3 times superior to BM alone.
• 75% of the initial weight loss was maintained at 12 months
• In this trail 18.8% early balloon removal, 5% has severe
symptoms first week, no medication were allowed to treat
symptoms, 80% resolved in less than 1 week
– Nausea 87%
– Vomiting 76%
– Pain 58%
– GERD 30%

18. Other Balloons work in similar mechanism, there is no head to head comparison

19. Lessons Learned From Initial
Balloon Experience
• Aggressive regimen to prevent and treat
symptoms, before, intra and post procedure
 Antiemetics and antispasmodic routine use in the
first week after placement then as needed
 Start PPIs (strong acid reducing medication) 2
weeks before and for the entire duration of balloon
placement
 Aggressive hydration
 Daily phone call to check on symptoms control
and hydration status in the first week

20. Lesson Learned From
Initial Balloon Experience
• Ongoing dietician evaluation
 Before placement, at 1 week after placement,
and at least once a month until balloon
removed, then 3 and 6 months after removal
 More patient contact, more weight loss in lap
band group
• EWL 40% in 1-2 fu visit vs 70% >10 visit
• Majority of weight loss occurs in the first 3
months
• May add medication later to augment
weight loss

21. Quick Summary

22. Orbera Intragastric Balloon
• Patient needs to be motivated, has realistic
expectations, and has a good support system
• Temporary tool
 Allow body to get used to a smaller portion
 Aid in weight loss
 Rehab period of old habits
• It is out of pocket payment, be sure you do not
waste your time and money
• We strongly believe early intervention before
morbid obesity has a huge benefit both from
health prospective and emotional well being

23. Early childhood good habits are a must
Prevention better than Intervention
Educate, Educate yourself, and your Children about healthy
lifestyle

24. Questions & Answers