Simon DexterLeeds Teaching Hospitals

Trust

Year Band Insertions Removals2006-07 715 112007-08 1,044 452008-09 1,382 462009-10 1,638 822010-11   1,555 1252011-12 1,316 124

Year No. of gastric bypasses2006-07 8582007-08 1,3122008-09 2,5332009-10 3,7452010-11 4,7222011-12 5,407

Health and Social Care Information Centre

Mechanism of action

Volume restriction Malabsorption Gut hormone changes Vagal activation Dumping Altered taste & food cravings Emotional wellbeing Physical ability Set point theory

Metabolic surgery

Sjostrom et al (2004) NEJM

Foregut•Ghrelin, duodenal exclusion

Hindgut•GLP-1, PYY release

Novel procedures

SURGICAL PLACEMENT

Gastric electrical stimulation

ENDOSCOPIC PLACEMENT

Endobarrier Intragastric balloon POSE

6 months maximum

Weight loss 2 – 4 stone

Anchor• Nitinol• Large proximal opening• Barbs in each direction• Retrieval drawstrings

Liner• Impermeable fluoropolymer• 60 cm length

Delivery System– Pre-loaded with implant– Sterile, single use

Retrieval System– Endoscopic grasper, hood

– Sterile, single use

4

Long-term T2DMimprovement

with weight loss

Delayed T2DM reboundpost- removal

Safety

Second generationdevice

Immediate T2DMimprovement

>500 Subjects13 Studies

Post-Marketing/RegistryExperience

Non-randomized, single arm Single Center

• University of Sao Paulo (Sao Paulo, Brazil) Planned duration - 52 weeks Enrollment

• 22 subjects• BMI=30-65• HbA1c=6-11.5%

1 week liquid diet followed by institution’s Bariatric standard of care diet

12 Month Diabetes StudyReduction in HbA1c (n=13 completers)

-1.9

Baseline HbA1c = 8.9%

-2.3

1 YearData

11/13 subjects

HbA1c < 7%

6/11 subjectsHbA1c < 7%

12 Month Diabetes StudyImprovement in Cardiovascular Risk Factors (n=13 completers)

Baseline 52 weeks p value

Weight (kg) 121.8 ± 7.6 101.6 ± 5.7 <.0001

BMI (kg/m2) 45.3 ± 2.4 37.8 ± 1.8 <.0001

Waist circumference (cm) 131.6 ± 5.1 119.9 ± 5.1 <.0001

Total cholesterol (mg/dl)HDLLDLTriglycerides

205.4 ± 10.944.1 ± 3.7121.8 ± 9.7

214.2 ± 27.2

177.3 ± 8.943.1 ± 4.4104.4 ± 7.3

151.8 ± 14.2

0.00030.65

0.0050.005

Glucose (mg/dl) 174.9 ± 13.7 137.8 ± 13.1 0.009

Insulin (uU/mg) 21.1 ± 4.9 11.0 ± 1.5 0.034

HOMA IR 8.6 ± 1.9 3.7 ± 0.6 0.023

HbA1c (%) 8.9± 0.5 6.6 ± 0.3 <.0001

Data presented as mean ± SE

Compelling Impact on Key Risk Factors1 YearData

12 Month Diabetes StudyReduction in HbA1c (n=13 completers)

1 YearData

1 YearData

8.9%

6.6%

1 YearData

Mean Implant duration for all 22 subjects

Non-randomized, single arm Single Center

• Catolica University (Santiago, Chile) Planned duration - 52 weeks Treated

• 43 subjects• BMI: 35.4-58.4

1 week liquid diet followed by institution’s Bariatric standard of care diet

1 YearData

Baseline BMI = 45.2

Baseline 52 weeks p value

Weight (kg) 112.4 ± 2.4 89.8 ± 3.2 <.0001

BMI (kg/m2) 45.3 ± 0.8 36.1 ± 1.1 <.0001

Blood pressure (mmHg)SystolicDiastolic

134.0 ± 2.7 85.7 ± 1.3

124.7 ± 2.3 71.8 ± 1.8

0.003<.0001

Total cholesterol (mg/dl)HDLLDLTriglycerides

195.1 ± 7.0 44.3 ± 1.7119.9 ± 5.7

155.4 ± 14.2

159.6 ± 7.4 43.5 ± 1.5 93.9 ± 6.1

111.5 ± 10.0

<.00010.55

<.00010.001

Data presented as mean ± SE

Compelling Impact on Key Risk Factors1 YearData

12 Month Obesity StudyImprovement in Cardiovascular Risk Factors (n=27 completers)

All devices removed endoscopically

Common Events• Nausea, vomiting, abdominal pain

Rare Adverse Events • GI hemorrhage, dehydration, constipation,

diarrhea, hypoglycemia, vitamin or mineral deficiencies, liner obstruction

Gastric neuromodulation • Abiliti, Transcend - IGS

Gastric contractility modulation• Diamond (Tantalus)

Vagal stimulation• Vbloc

Diamond (Tantalus)• Gastric contractility modulation

Induces satiety signalling via CNS

DM2 study• HbA1c at baseline

7.8% -1.0 @ 1 year -1.1 @ 18/12

• %EWL 24.6% @ 18/12

Consumption - Expenditure Wt Change=

Gastric Stimulation• Creates early sensation of satiety• Reduces desire to eat between meals• Reduced meal volume

Patient Support System• Tracks & reports eating events• Tracks & reports exercise trends• Useful diagnostic for sleep disorders • Supports behavior modification

Low Impact• Excellent safety profile • Minimal lifestyle changes

• No special diets• No vitamin supplements

IntraPace: Abiliti™

GSA102 Analyzer

P102 Programmer

W102 Programmer

Wand

LGS102 Stimulator

LGL102

Lead

Unpublished data

Number ofSubjects

30

Gender 25 Females / 5 Males

Age (years)Mean, range

40 (20 to 60)

Weight (lb)Mean, range

284.6 (213.4 to 370)

Excess weight (lb)

124.6 (72.9 to 177.5)

BMIMean, range

43.8 (32.5 to 55)

Unpublished data

Bariatric surgery increasing Better understanding of mechanisms of action

Metabolic role of surgery Development of novel procedures