No more pain' No more pills'

1

• No more pain. No more pills.
• Get back to living!

120308
2
Symptoms of GERD

• Heartburn
• Acid regurgitation
• Sour or bitter taste in throat or mouth
• Esp. after large, late meals
• Water brash
• Hot sensation in stomach
• Excess salivation
• Dysphagia and Odynophagia
• Difficulty swallowing or painful swallowing

3
Other Symptoms of GERD

• ENT
• Hoarseness
• Laryngitis
• Sore throat
• Chronic cough
• Frequent swallowing
• Burning in the throat or mouth

• Pulmonary
• Asthma
• Aspiration pneumonia
• Chronic bronchitis
• Other
• Regurgitation
• Chest pain
• Dental erosion

Atypical symptoms
4
Causes of GERD
Contributing factors

• Overweight and Obesity
• Modern nutritional habits coffee, chocolate,
  carbonized drinks, fatty foods, etc.

Unfolding of Sphincter
Distention
DeMeester Gastric pathology as an indicator and
potentiator of gastroesophageal reflux disease.
Dis Esophagus, 1997 10(1)1-8
5
Root Cause of Moderate/Severe GERD

• Anatomical change and loss of natural antireflux
  valve

Normal AnatomyFully Functional Valve Prevents
Reflux
Abnormal Dysfunctional ValveGERD
6
USA GERD Incidence

• 10 - 15 of adult population suffers from daily
  GERD ( 15 MM)
• Incidence of GERD rises rapidly after 40 years of
  age
• Esophageal cancer is 8X more likely to occur in
  patients with weekly heartburn or regurgitation

7
PPIs are not the solution for severe or chronic
reflux
Severe and Chronic GERD

• Does not stop
• Reflux
• Non Erosive Reflux Disease (NERD)
• Regurgitation
• ANATOMICAL CHANGES NEED ANATOMICAL REPAIRS

Normal
Abnormal
8
Continued Reflux Symptoms on Medications
Gallup Poll Reflux 72 on Medication
79 Nighttime symptoms 50 Nighttime
reflux worse than daytime reflux 63 Ability
to sleep affected 40 Daytime function
affected 70 Nighttime discomfort moderate to
severe 75 Can not fall asleep or wakes them
up 45 Medication does not relieve all
symptoms
20-40 of patients dissatisfied with PPI
medication
Gallup Poll 2000 for AGA N 1000 American
Journal of Gastroenterology 2003 vol. 98 Shaker
et al
9
Patients Needing a New Approach
Long-term Implications

• Young patients at risk for long-term
  complications with chronic drug therapy
• At risk for osteoporosis
• Barretts and esophageal cancer risk increase
• Drug-drug interaction issues
• Adverse events from PPIs
• Patients who do not want to take drugs for life
• Non Erosive Reflux Disease (NERD)

10
GERD Treatment Options

• Limitations of Pharmaceuticals
• Treat only the symptoms not the cause
• Do not stop reflux
• Do not treat non-heartburn symptoms (asthma,
  hoarseness, coughing)

• Benefits of EsophyX
• GEJ reconstructed
• PPIs reduced or eliminated
• Hiatal Hernia fixed lt 2cm
• Significant pH Normalization
• Improved Quality of Life
• Reduce/Eliminate reflux
• Adjustment possible

11
EsophyX TIF
TIF (Transoral Incisionless Fundoplication)

• No incisions
• No scarring
• No incisional herniation
• Less potential for infection - nosocomial
  infection minimized
• Patient friendly
• Rapid return to work and normal activities

Unique Surgical Approach
12
EsophyX Animation
Unique Surgical Approach
13
EsophyX Experience

• Reconstructs the natural primary barrier to
  reflux by creating a robust valve

• 45 - 60 minute procedure
• 8 - 14 fasteners SerosaFuse fasteners (3.0
  non-absorbable propylene sutures)
• Overnight stay (general anesthesia)
• Post-op discomfort minimal
• Rapid recovery Most patients are back to work
  and most activities in a couple of days

Unique Surgical Approach
14
Multi Center Trial (1 year) N79
85 of Patients OFF daily PPIs

• Minimal risk of adverse events
• Excellent QOL improvement 73
• Elimination of PPI use 85
• Esophagitis resolution 59
• Hiatal hernia reduction 71
• pH normalization 49 (Hill grade one)

Clinically Safe Effective
15
Phase 2 Dietary Changes
Patients can enjoy foods that caused reflux off
PPIs
P lt 0.01
16
Phase 2 Dietary Changes
Patients can enjoy more foods than they could on
PPIs without reflux
17
Multi Center Trial (2 years) N79

• Minimal risk of adverse events
• Patients satisfied with treatment 86
• Patients can consume reflux causing 60-80
  foods without symptoms

Clinically Safe Effective
18
Effectiveness - Conclusions

• EsophyX-TIF was shown to be effective in treating
  chronic GERD as indicated by the significantly
  improved quality of life and reduced dependency
  on daily PPIs.
• The results at 12 and 24 mo supported a long-term
  maintenance of the anatomical integrity of TIF
  valves.