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THE BALLOON AND THE G-TUBE: HOW DO THEY FIT IN ALGORITHM FOR THE TREATMENT OF THE OBESITY IN THE U.S.?

Jaime Ponce, MD, FACS, FASMBS Medical Director of Bariatric Surgery CHI Memorial Hospital Chattanooga, TN

2017 Duke Masters of Minimally Invasive Bariatric Surgery Orlando FL– June 24, 2017 Disclosures

• Gore: speaker, consultant • ReShape Medical: speaker, consultant • USGI Medical: research • Olympus: speaker, consultant • Obalon: research • Allurion: research • Ethicon: consultant

United States Bariatric Surgery Numbers Estimation

ASMBS total bariatric procedures numbers from 2011, 2012, 2013, 2014 and 2015 based on the best estimation from available data (BOLD, ACS/MBSAQIP, National Inpatient Sample data and outpatient estimations) SOARD 2015

0%

10%

20%

30%

40%

50%

2011N=158,000

2012N=173,000

2013N=179,000

2014N=193,000

2015N=196,000

RNY

Sleeve

Band

BPD/DS

2015

RNY 23.1%

Band 5.7%

Sleeve 53.8%

BPD/DS 0.6%

Rev 13.6%

Other 3.2%

Less than 1% of eligible population are having bariatric surgery….

20+ million potential eligible “candidates” for bariatric surgery

< 1%

Obesity in America Survey (2016): ASMBS and NORC at the University of Chicago

Conduct custom national survey of 1,500 adults (including oversample of African Americans and Hispanics) about their perceptions of obesity and its treatment in America

Fear Factor ?

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Patients that are willing to have surgery: •  81% fear surgical complications •  71% concerned of the of

procedures safety •  63% have a fear of surgery in

general •  48% fear the unknown ??

Obesity Care

34.4% 26.2% 5.7%

Treatment Options BMI % of US population

Diet, Rx and Lifestyle

Surgery

25-30 kg/m2 30-40 kg/m2 >40 kg/m2

26.2%

Treatment Gap

JAMA 2010;303:235-41

Endoscopic Therapies

Endoscopic Bariatric Therapies (EBT) • Upper endoscopy procedure • Potential for:

•  Ambulatory procedure •  Lower cost •  Safer than laparoscopic surgery

• Efficacy (variable) • May address untreated Class I and II Obesity

Balloons in the U.S. (Fluid filled)

Single Balloon Dual Balloon

Balloons in the U.S. (Gas filled)

Gas filled swallowable balloon

Swallowable Capsule

Balloons outside U.S.

Air filled Adjustable

Fluid filled Swallowable/Excretable

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Garren-Edwards Gastric Bubble 1985 Single Balloon

1/7/15, 12:59 PMGastric Balloon; Gastric Bubble; Ballobes Balloon; Garren-Edwards Gastric Bubble

Page 1 of 4http://www.lookfordiagnosis.com/mesh_info.php?term=Gastric+Balloon&lang=1

Gastric Balloon (Gastric Bubble; Ballobes Balloon; Garren-EdwardsGastric Bubble)

An inflatable device implanted in the stomach (/mesh_info.php?term=stomach&lang=1) as an adjunct to therapy of morbid (/mesh_info.php?term=obesity&lang=1). Specific types include the silicone Garren-Edwards Gastric Bubble (GEGB), approved by the FDA in 1985, and the BallobesBalloon.

Images

(http://www.weightlossvic.com.au/orbera-intragastric-

balloon_files/stacks_image_55.png)

Sometimes surgeryfor weight

www.weightlossvic.com.au

(http://www.ossanz.com.au/images/ossanz_gastric_ballooning.jpg)

Gastric Ballooning -Obesity

www.ossanz.com.au

(http://www.bariatriccookery.com/wp-content/uploads/2013/07/gastric-

balloon.jpg)

(http://www.praguebeauty.co.uk/img/article/116/gastric-balloon-

43397506.jpg)

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Gastric Balloon

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• Primary Endpoint: •  More than 30% of the IGB group achieve > 15% EWL compared to

control

Orbera pivotal FDA trial in the U.S.

45.6%

0% 30% 60%

• Second Primary Endpoint: •  Mean %EWL in the IGB group > 25% at 9 months

Orbera pivotal FDA trial in the U.S.

26.5%

0% 25% 50%

• Weight loss at 6 months: •  Mean TBWL 10.2% vs 3.3% control group •  38.4% EWL

•  FDA approval: August 5, 2015

Orbera pivotal FDA trial in the U.S. ASGE meta-analysis (2015) •  82 publications •  6,845 pts •  TBWL at 6 months: 13.16% •  TBWL at 12 months: 11.1% (25.4%EWL)

dietitians, and bariatric surgeons. EBTs should comple-ment, rather than compete with, current obesity therapyoptions and should be used as adjunctive therapy as out-lined in a previous ASGE publication.6 Endoscopy exper-tise should be incorporated within a multidisciplinaryteam to optimize the care of patients with obesity.

Limitations of our meta-analyses include the high de-gree of heterogeneity among included studies, risk ofbias in non-RCT studies, different methods used amongstudies to report the %EWL (Metropolitan Life Tables vsBMI 25 method), and lack of sufficient data to evaluateall PIVI-defined thresholds. One of the thresholds requiresa comparison of EBT weight loss outcomes with a control(not sham) group. To optimize power, we included studiesthat compared EBTs with both sham and control groups.Furthermore, there were insufficient data available to eval-uate the use of low-risk EBTs with significant impact on1 or more obesity-related comorbidities in Class I obesepatients.

The ASGE will continue to work with ASGE membersand other medical societies involved in obesity therapyto promote and facilitate widespread adoption and imple-mentation of safe and effective EBTs in clinical practice.

DISCLOSURE

Dr Abu Dayyeh is a consultant for and has received agrant fromApollo Endosurgery; is a consultant forMetamo-dix; has received grant support from Aspire Bariatric andresearch support from GI Dynamics. Dr Edmundowicz isa consultant for and serves on the advisory board of BostonScientific, Olympus, GI Dynamics, and Fractyl; is a stock-holderand serves on theadvisory board for SynerZMedical;is a consultant for Beacon Endoscopic; and has receivedinstitutional research grants from Aspire Bariatrics, USGI, ReShape Medical, Obalon, and Baranova. Dr Sullivanis a consultant for Obalon and has performed contractedresearch for ReShape Medical, GI Dynamics, Aspire Bariat-rics, and USGI Medical. Dr Jonnalagadda served on thedata safety monitoring and clinical events monitoringcommittee for ReShape Medical. Dr Thompson is a consul-tant for Boston Scientific, Covidien, Beacon Endoscopic,Apollo Endosurgery; received lab support from Olympus,a research grant fromAspire Bariatrics, and has an owner-ship interest in GI Windows. All other authors disclosed nofinancial relationships relevant to this publication.

ACKNOWLEDGMENTS

The ASGE Bariatric Task Force acknowledges thefollowing individuals for their contribution to this work:Larry Prokop (Librarian) for conducting the literaturesearches, Badr Al Bawardy, MD, for his assistance in dataextraction and organization, and Violeta Popov, MD, foran external critical review of the data collection.

Abbreviations: ASGE, American Society for Gastrointestinal Endoscopy;BMI, body mass index; CI, confidence interval; DJBS, duodenal-jejunalbypass sleeve; EBT, endoscopic bariatric therapy; %EWL, percentage ofexcess weight loss; HgA1c, glycosylated hemoglobin; IGB, intragastricballoon; PIVI, Preservation and Incorporation of Valuable endoscopicInnovations; RCT, randomized, controlled trial; %TBWL, percentage oftotal body weight loss.

Orbera IGB adverse events70

60

50

40

30

20

10

0

% 33.729

18.312

7.52 1.4 0.3 0.1 0.08

Pain

NauseaGERD

Erosion

Early re

movalUlce

r

Migration

SBO

Perforatio

nDeath

Figure 11. Pooled rates of adverse events observed with the Orbera intra-gastric balloon (IGB). SBO, small bowel obstruction.

90

58.7

39.4

18.37

4.93 4.2 3.866 3.470.126 0.126 0.126 0.126

EndoBarrier adverse events

80

70

60

50% 40

30

20

10

0

Pain

Nausea/V

omitt

ing

Early re

moval

Migratio

n

Pain require

ealry re

moval

Gl bleeding

Sleeve obstructio

n

Liver absc

ess

Cholangitis

Acute

Cholecystitis

Esophageal P

erforatio

n

Figure 12. Pooled rates of adverse events observed with the EndoBarrier.

26.5024.1521.8019.4517.1014.7512.4010.05

7.705.353.00

24.55 29.41 34.27 39.13 43.99 48.85 53.71 58.57 63.43 68.29 73.15

% T

BWL

Pre-treatment BMI

P=.09

%TBWL with Orbera IGB at a range of base-line BMI

Figure 10. Meta-regression linear plot depicting the best-fit regressionline of the association between baseline body mass indexes (BMIs) andpercentage of excess weight loss (%EWL) at 6 months after Orbera intra-gastric balloon (IGB) implantation. The sample size of individual studies isproportional to the diameter of the circle by which it is represented onthe graph.

www.giejournal.org Volume 82, No. 3 : 2015 GASTROINTESTINAL ENDOSCOPY 435

Assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies

ASGE meta-analysis IGB complications

dietitians, and bariatric surgeons. EBTs should comple-ment, rather than compete with, current obesity therapyoptions and should be used as adjunctive therapy as out-lined in a previous ASGE publication.6 Endoscopy exper-tise should be incorporated within a multidisciplinaryteam to optimize the care of patients with obesity.

Limitations of our meta-analyses include the high de-gree of heterogeneity among included studies, risk ofbias in non-RCT studies, different methods used amongstudies to report the %EWL (Metropolitan Life Tables vsBMI 25 method), and lack of sufficient data to evaluateall PIVI-defined thresholds. One of the thresholds requiresa comparison of EBT weight loss outcomes with a control(not sham) group. To optimize power, we included studiesthat compared EBTs with both sham and control groups.Furthermore, there were insufficient data available to eval-uate the use of low-risk EBTs with significant impact on1 or more obesity-related comorbidities in Class I obesepatients.

The ASGE will continue to work with ASGE membersand other medical societies involved in obesity therapyto promote and facilitate widespread adoption and imple-mentation of safe and effective EBTs in clinical practice.

DISCLOSURE

Dr Abu Dayyeh is a consultant for and has received agrant fromApollo Endosurgery; is a consultant forMetamo-dix; has received grant support from Aspire Bariatric andresearch support from GI Dynamics. Dr Edmundowicz isa consultant for and serves on the advisory board of BostonScientific, Olympus, GI Dynamics, and Fractyl; is a stock-holderand serves on theadvisory board for SynerZMedical;is a consultant for Beacon Endoscopic; and has receivedinstitutional research grants from Aspire Bariatrics, USGI, ReShape Medical, Obalon, and Baranova. Dr Sullivanis a consultant for Obalon and has performed contractedresearch for ReShape Medical, GI Dynamics, Aspire Bariat-rics, and USGI Medical. Dr Jonnalagadda served on thedata safety monitoring and clinical events monitoringcommittee for ReShape Medical. Dr Thompson is a consul-tant for Boston Scientific, Covidien, Beacon Endoscopic,Apollo Endosurgery; received lab support from Olympus,a research grant fromAspire Bariatrics, and has an owner-ship interest in GI Windows. All other authors disclosed nofinancial relationships relevant to this publication.

ACKNOWLEDGMENTS

The ASGE Bariatric Task Force acknowledges thefollowing individuals for their contribution to this work:Larry Prokop (Librarian) for conducting the literaturesearches, Badr Al Bawardy, MD, for his assistance in dataextraction and organization, and Violeta Popov, MD, foran external critical review of the data collection.

Abbreviations: ASGE, American Society for Gastrointestinal Endoscopy;BMI, body mass index; CI, confidence interval; DJBS, duodenal-jejunalbypass sleeve; EBT, endoscopic bariatric therapy; %EWL, percentage ofexcess weight loss; HgA1c, glycosylated hemoglobin; IGB, intragastricballoon; PIVI, Preservation and Incorporation of Valuable endoscopicInnovations; RCT, randomized, controlled trial; %TBWL, percentage oftotal body weight loss.

Orbera IGB adverse events70

60

50

40

30

20

10

0

% 33.729

18.312

7.52 1.4 0.3 0.1 0.08

Pain

NauseaGERD

Erosion

Early re

movalUlce

r

Migration

SBO

Perforatio

nDeath

Figure 11. Pooled rates of adverse events observed with the Orbera intra-gastric balloon (IGB). SBO, small bowel obstruction.

90

58.7

39.4

18.37

4.93 4.2 3.866 3.470.126 0.126 0.126 0.126

EndoBarrier adverse events

80

70

60

50% 40

30

20

10

0

Pain

Nausea/V

omitt

ing

Early re

moval

Migratio

n

Pain require

ealry re

moval

Gl bleeding

Sleeve obstructio

n

Liver absc

ess

Cholangitis

Acute

Cholecystitis

Esophageal P

erforatio

n

Figure 12. Pooled rates of adverse events observed with the EndoBarrier.

26.5024.1521.8019.4517.1014.7512.4010.05

7.705.353.00

24.55 29.41 34.27 39.13 43.99 48.85 53.71 58.57 63.43 68.29 73.15

% T

BWL

Pre-treatment BMI

P=.09

%TBWL with Orbera IGB at a range of base-line BMI

Figure 10. Meta-regression linear plot depicting the best-fit regressionline of the association between baseline body mass indexes (BMIs) andpercentage of excess weight loss (%EWL) at 6 months after Orbera intra-gastric balloon (IGB) implantation. The sample size of individual studies isproportional to the diameter of the circle by which it is represented onthe graph.

www.giejournal.org Volume 82, No. 3 : 2015 GASTROINTESTINAL ENDOSCOPY 435

Assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies

Gastric occlusion

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Gastric occlusion

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Dual Balloon

41

FeaturesDual,independentlyfilledballoonstoavoidmigraDonincaseofoneballoondeflaDon

Two balloons inflated Distal balloon deflated

42

Blue/green urine

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43

FeaturesMaximumspaceoccupaDonwithevenlydistributed900ccfillvolume

450cc

450cc

44

FeaturesConformstostomachcurvaturewithdualballoonstability

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The REDUCE Pivotal Trial

A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the

ReShape® Integrated Dual Balloon System in Obese Subjects

Jaime Ponce MD, George Woodman MD, James Swain MD, Erik Wilson MD, Wayne English MD, Sayeed Ikramuddin MD, Eric Bour MD,

Steven Edmundowicz MD, Brad Snyder MD, Flavia Soto MD, Shelby Sullivan MD, Richard Holcomb PhD and John Lehmann MD

31st ASMBS Annual Meeting - ObesityWeek Scientific Session: Top 10 Papers Boston, MA – November 4, 2014

Surg Obes Relat Dis (July 2015)

%EWL Primary Endpoint Met: DUO significantly > DIET + 7.5%

REDUCE Pivotal Trial

Responder Rate Primary Endpoint Met: DUO responders significantly > 35%

REDUCE Pivotal Trial

•  FDA approval: July 28, 2015

Reshape Dual Balloon

X-Ray

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Proximal balloon deflated with food bezoar

Proximal balloon deflated Balloon covered with a microbial biofilm

Balloon with air fluid level Balloon with air fluid level

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Superficial ulcer (0.3 cm) at the incisura Ulcers at the incisura with follow-up endoscopy

3.3 months 4.5 months 2.5 months

Early Experience with Intragastric Dual Balloon as Treatment for Obesity

JO H N MO RTO N, MD MPH FACS FASMBS HA B I B KH O U RY BS; NI N H NG U Y E N MD;

TR A C E CU R RY MD; JA I M E PO N C E MD

ASMBS oral presentation plenary session ObesityWeek 2016

Results Table 1. Preoperative study population demographics

Number of Patients, n 137

Age, y (mean) 52.8

Weight, lbs (mean) 233.4± 6.1

BMI* (mean) 37.3± 0.8

Weight Loss Medication Used, % 26.3

Liquid Diet Used, % 28.5

PONV Prophylaxis Used

Zofran, Emend, Phenergan, Promethazine, Reglan,

Erythromycin, Scopalamine Patch, Ativan, Levsin

*BMI, body mass index; calculated as kg/m2

87% Female 4 U.S. Centers

Results

Table 2. Postoperative study complicationsBalloons Removed, # 103Complications, # 11 (8%)

Deflations, # 1 (1 Day prior Scheduled Removal)

Ulcers, # 3 (2%)Dehydration, # 3Bleed, # 2 Gallstones, # 1Gastritis, # 2

Results Table 3. Postoperative study outcomes in weight loss and

comorbidityPre-Op 6 Months Post-Op

Weight, lbs (mean ± SE) 233.4 ± 6.1 208.7 ± 5.7 [-2.8 – 100]

BMI* (mean ± SE) 37.3 ± 0.8 33.3 ± 0.8 [-0.1 – 15.7]

EWL, % (mean ± SE) N/A 32.5 ± 2.6 [-1.8 – 129.7]

EWL > 25, % N/A 59.2Comorbidity, #

(mean ± SE) 1.9 ± 0.1 1.0 ± 0.1

*BMI, body mass index; calculated as kg/m2

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Patients who enter more weight values have greater reported weight loss

Swallowable Gas-Filled Balloon System

Swallowable Capsule

EzFill Inflation System Gas-Filled Balloon

Balloon System Procedure

The patient swallows a capsule under radiography - no sedation or anesthesia required.

1Once in the stomach, Balloon is inflated with gas. 3 Balloons placed over 3 months.

2

Balloons removed endoscopically at 6 months

3

Swallowing capsule

Swallowable Gas-Filled Balloon

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Appearance of Balloons

Fully inflated balloon at normal stomach temperature and pressure

Temperature change during endoscopy may cause condensation

Fully inflated balloon

Swallowable Gas-Filled balloon removal The image cannot be displayed. Your computer may not have enough memory to open the image, or the image may have been corrupted. Restart your computer, and then open the file again. If the red x still appears, you may have to delete the image and then insert it again.

The Obalon Swallowable 6-Month Balloon System is More Effective than Moderate

Intensity Lifestyle Therapy Alone: Results from a Six-month Randomized Sham

Controlled Trial (SMART trial)

Shelby Sullivan, James Swain, George Woodman, Steven Edmundowicz, Tarek Hassanein, Vafa Shayani, John C. Fang, George Eid, Wayne Joseph English, Nabil Tariq,

Michael Larsen, Aurora D. Pryor, Sreenivasa S. Jonnalagadda, Dennis S. Riff, Jaime Ponce, and Mark Noar

)presented at DDW and ObesityWeek 2016)

15 US Research Center Participants Principal Investigator, Specialty Site Name/Location

George M. Eid, MD, Bariatric Surgeon West Penn Hospital(Pittsburgh, PA)Wayne J. English, MD, FACS, Bariatric Surgeon

Vanderbilt University Medical Center (Nashville, TN)

John C. Fang, MD, Gastroenterology University of Utah Hospital (Salt Lake City, UT)

Tarek I. Hassanein, MD, Bariatric Surgeon Southern California Research Center (Coronado, CA)

Sreeni S. Jonnalagadda, MD, FASGE, Gastroenterology

Saint Luke's Hospital of Kansas City (Kansas City, MO)

Michael C. Larsen, MD, Gastroenterology Virginia Mason Medical Center (Seattle, WA)

Mark D. Noar, MD, MPH, Gastroenterology Endoscopy Microsurgery Associates (Towson, MD)

Jaime Ponce, MD, FACS, FASMBS, Bariatric Surgeon Chattanooga Bariatrics (Chattanooga, TN)

Aurora D. Pryor, MD, FACS, Bariatric SurgeonStony Brook Medicine (Stony Brook, NY)

Dennis S. Riff, MD, FACG, CPI, Gastroenterology Anaheim Clinical Trials (Anaheim, CA)

Vafa Shayani, MD, FACS, FASMBS, Bariatric Surgeon

Bariatric Institute of Greater Chicago (Bolingbrook, IL)

Shelby Sullivan, MD/Steven Edmundowicz, Gastroenterology

Washington University School of Medicine (St. Louis, MO)

James M. Swain, MD, Bariatric Surgeon HonorHealth Research Institute (Scottsdale, AZ)

Nabil Tariq, MD, Bariatric Surgeon Houston Methodist Research Institute (Houston, TX)

George E. Woodman, MD, FACS, Bariatric Surgeon George E. Woodman, MD (Memphis, TN)

The Six-Month Adjunctive Weight Reduction Therapy (SMART) Trial Design

•  Double-blind RCT-Sham Controlled Study •  Active Sham Design with

Identical Administration Procedure

•  Device Swallow on Day 0, Week 3, and either Weeks 9 or 12 •  Preventative treatment with anti-

spasmodic and anti-emetic medications at each swallow visit

•  Proton Pump Inhibitor therapy starting one week before Day 0

•  Moderate Intensity Lifestyle Therapy •  25 min, every 3 weeks

Un-blind/Device Endoscopic

Removal

Un-blind/ No Endoscopic

Removal

Enrollment/Screening/ Randomization (1:1)

3 Balloons+ Weight Loss Program

(6 months)

Sham + Weight Loss Program (6 months)

Endpoint Analysis (6 months)

Observational Weight Loss Program

(6 months)

Observational (Optional) 3 Balloons + Weight Loss

Program (6 months)

Trial Summary •  419 Subjects Randomized with 2 Swallow Attempts •  387 Subjects Treated (≥ 1 Device Swallowed) •  366 Subjects included in Per Protocol Population

•  ≥ 2 Devices Swallowed with ≥ 18 weeks of therapy

• Co-Primary Efficacy Endpoints: •  Mean percent total body weight loss (%TBWL) difference:

Treatment vs Control •  Treatment Responder Rate : ≥5% TBWL in ≥35% Subjects

• Observational Safety Endpoint: •  All Device Related Adverse Events (AE, Serious and Non-Serious)

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Per Protocol Demographics

Baseline Treatment

(n=185) Control (n=181) P-value

Female (%) 85.9 90.1 0.2268 Age (years) 42.8 ± 9.5 42.7 ± 9.4 0.9019 BMI (kg/m2) 35.2 ± 2.7 35.5 ± 2.7 0.3537

Weight (kg) 98.2 ±13.4 98.6 ± 12.1 0.7779

Hypertension (%) 15.7 14.9 0.8403

Race White (%) 83.8 82.3

0.0927 Black (%) 9.7 14.9 Other (%) 6.5 2.8 Ethnicity

Non-Hispanic / Latino (%) 93.0 87.3

0.0681 Hispanic / Latino (%) 7.0 12.7

Administration and Removal Summary

• Balloon Administration Procedure •  Time: 9.5 ± 4.1 minutes

• Balloon Removal Procedure •  Time: 16.9 ± 8.5 minutes (99.5% Performed using monitored

Anesthesia care/propopfol)

Administration Treatment Group Control Group

1st Device 198 / 216 (91.7%) 189 / 203 (93.1%)

2nd Device 193 / 195 (99.0%) 187 / 188 (99.5%)

3rd Device 183 / 185 (98.9%) 181 / 182 (99.5%)

Early Balloon Removals Category < 18 Weeks ≥ 18 Weeks Combined

(n = 198)

Protocol Compliance 2 (1.0%) 4 (2.0%) 6 (3.0%)

Subject Related 3 (1.5%) 2 (1.0%) 5 (2.5%)

Symptom Related 3 (1.5%) 1 (0.5%) 4 (2.0%)

Device Issue 2 (1.0%) 2 (1.0%) 4 (2.0%)

ALL 10 (5.1%) 9 (4.5%) 19 (9.6%)

Obalon 6-month Balloon Deflation Risk •  1 Balloon Deflation at 21 weeks Use •  No migration or obstruction •  Subject reported new onset of epigastric

pain leading to removal •  Obalon investigation concluded

manufacturing (not design) defect. Isolated occurrence.

•  Study Deflation Rate: Phase I Deflation Rate: 1/574 Balloons (0.13%)

PP Co-Primary Endpoint Mean % Total Body Weight Loss

-8.0

-7.0

-6.0

-5.0

-4.0

-3.0

-2.0

-1.0

0.0

Week 00 Week 03 Week 06 Week 09 Week 12 Week 15 Week 18 Week 21 Week 24

Perc

ent

Treatment Control

-6.81

P=0.0338 Mean Difference: 3.23%

-3.59

179/185(96.8%)TreatmentGroupwith3Balloons,179/181(98.9%)ControlGroupwith3Shams

PP Co-Primary Endpoint Responder Rate (≥ 5% TBWL)

64.3%

32.0%

0

10

20

30

40

50

60

70

Treatment Control

% S

ubje

cts

P< 0.0001

179/185(96.8%)TreatmentGroupwith3Balloons,179/181(98.9%)ControlGroupwith3Shams

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Adverse Device Effects (>5%) ADE # Events

Subjects (%)

n=198

Mild (% Events)

Moderate (% Events)

Severe (% Events)

Abdominal Pain 292146

(73.7%)270

(92.5%) 22 (7.5%) 0 (0.0%)

Nausea 181108

(54.5%)168

(92.8%) 13 (7.2%)0 (0.0%)Indigestion/ Heartburn 38 33 (16.7%)30 (78.9%)8 (21.1%)0 (0.0%)

Vomiting 37 29 (14.6%)30 (81.1%)7 (18.9%)0 (0.0%)

Bloating 28 26 (13.1%)27 (96.4%) 1 (3.6%) 0 (0.0%)Burping/ Belching 26 20 (10.1%)

26 (100.0%) 0 (0.0%) 0 (0.0%)

Diarrhea 14 13 (6.6%)14

(100.0%) 0 (0.0%) 0 (0.0%)

SMART Trial Summary • SMART Trial Met Co-Primary Efficacy Endpoints

•  3.23% TBWL greater in Treatment Group, p=0.0338 •  64.3% Responder Rate, p< 0.0001

•  Low adverse event rate for Obalon Balloon System •  99.7% adverse device events were mild-moderate •  0.3% of adverse device events were severe

•  The Results suggest the Obalon 6-month Balloon System is a safe obesity treatment with high patient tolerability and significantly more weight loss than lifestyle therapy alone

•  FDA approval: September 12, 2016

Level 1 evidence

N=12 RCT’s

Level 1 evidence

N=10 RCT’s and 30 observational studies

Level 1 evidence • RCT data showed better weight loss w/ IGB >400 ml than

sham/diet •  IGBs are more effective than diet in improving obesity-

related metabolic risk factors (the strength of the evidence is limited: small number of participants and lack of long-term follow-up)

The Future: Fluid filled Swallowable/Excretable balloon

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Conclusions: Intragastric Balloon • Can help to manage patients with Obesity class 1 and 2

(BMI 30-40) that don’t qualify for surgery or are not ready for surgery

• Offer better weight loss than diet and exercise alone •  Lower risk than surgery • Effectiveness is more variable • Durability is shorter • Additional tool for management of obesity

Aspiration Therapy (Aspire Assist)

Aspiration Therapy • Outpatient procedure • Endoscopic percutaneous gastrostomy device • Allows aspiration (empty) up to 30% of the meal into the

toilet • Aspiration performed 20-30 minutes after meal and takes

5-10 minutes to complete • Requires good food chewing to work • Physician controls number of aspirations: ideally 3 times a

day • Reversible (removal requires endoscopy and sedation)

Aspiration Therapy

Aspiration Therapy (Aspire Assist)

Thompson C, et al. Am J Gastroenterol. Dec 2016 (epub)

Adverse Events

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Aspiration Therapy: FDA trial • BMI 35-55 • N=1 demonstrated, at weeks 14 and 28 (as well at

screening), evidence of binge eating behavior when evaluated by using the Questionnaire on Eating and Weight Patterns-Revised, but not by using the Eating Disorders Examination, and hence was allowed to continue in the study.

• No evidence of bulimia in any subject was detected by using either the Questionnaire on Eating and Weight Patterns- Revised or the Eating Disorders Examination at baseline, or at weeks 14, 28, or 52.

•  FDA approval: June 14, 2016

Conclusions: Aspiration Therapy • Can be an option to manage patients with Obesity class 2

and 3 (BMI 35-55) that are not ready for surgery • Offer better weight loss than diet and exercise alone (3X) •  Lower risk than surgery • Effectiveness is more variable than surgery • Durability? • Additional tool for management of obesity

ObesityWeek 2017 New in 2017

• 5,000+ attendees to build connections with top-notch professionals in the field of bariatric surgery • 70+ countries attending bring diverse international perspectives

• ePosters • Multiple oral and abstract video sessions • Video Bar • International Session in Portuguese

Thank You