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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

                      

                      

                      

                      

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Other Symptoms of GERD

PulmonaryAsthma

Aspiration pneumonia

Chronic bronchitis

OtherRegurgitation

Chest pain

Dental erosion

ENTHoarseness

Laryngitis

Sore throat

Chronic cough

Frequent swallowing

Burning in the throat or mouth

Atypical symptoms

                      

                      

                      

                      

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Causes of GERD

DeMeester: Gastric pathology as an indicator and potentiator of gastroesophageal reflux disease. Dis Esophagus, 1997; 10(1):1-8

• Overweight and Obesity

• “Modern” nutritional habits: coffee, chocolate, carbonized drinks, fatty foods, etc.

Unfolding of Sphincter

Distention

Contributing factors:

                      

                      

                      

                      

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Root Cause of Moderate/Severe GERD

Normal AnatomyFully Functional Valve Prevents Reflux

Anatomical change and loss of natural antireflux valve

Abnormal Dysfunctional ValveGERD

                      

                      

                      

                      

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• 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

USA GERD Incidence

                      

                      

                      

                      

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PPIs are not the solution for severe or chronic reflux

Does not stop • Reflux • Non Erosive Reflux

Disease (NERD)• Regurgitation

ANATOMICAL CHANGES NEED ANATOMICAL REPAIRS

Severe and Chronic GERD

Normal

Abnormal

                      

                      

                      

                      

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Continued Reflux Symptoms on Medications

Gallup Poll Reflux*72% on Medication

79% Nighttime symptoms50% Nighttime reflux worse than daytime reflux63% Ability to sleep affected40% Daytime function affected70% Nighttime discomfort moderate to severe75% Can not fall asleep or wakes them up45% Medication does not relieve all symptoms

*Gallup Poll 2000 for AGA N = 1000 American Journal of Gastroenterology 2003; vol. 98 Shaker et al

20-40% of patients dissatisfied with PPI medication

                      

                      

                      

                      

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• Young patients at risk for long-term complications with chronic drug therapy

• At risk for osteoporosis• Barrett’s 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)

Patients Needing a New Approach

Long-term Implications

                      

                      

                      

                      

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Limitations of Pharmaceuticals• Treat only the symptoms – not the

cause

• Do not stop reflux

• Do not treat non-heartburn symptoms (asthma, hoarseness, coughing…)

GERD Treatment Options

Benefits of EsophyX• GEJ reconstructed

• PPIs reduced or eliminated

• Hiatal Hernia fixed < 2cm

• Significant pH Normalization

• Improved Quality of Life

• Reduce/Eliminate reflux

• Adjustment possible

                      

                      

                      

                      

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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

                      

                      

                      

                      

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EsophyX Animation

Unique Surgical Approach

                      

                      

                      

                      

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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

                      

                      

                      

                      

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Multi Center Trial (1 year) N=79

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

                      

                      

                      

                      

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0%

20%

40%

60%

80%

100%

Citrus*

Strawberries*

Tomatoes*

Chocolate*

Fatty Foods*

Deep-Fried Foods*

Spicy Foods*

Carbonated Drinks*

Tea*

Coffee*

Caffeinated Drinks*

Alcohol*

12 mo Post-TIF Pre-TIF OFF PPIs

Phase 2 – Dietary Changes

*P < 0.01

Patients can enjoy foods that caused reflux off PPIs

                      

                      

                      

                      

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Phase 2 – Dietary Changes

Patients can enjoy more foods than they could on PPIs without reflux

                      

                      

                      

                      

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Multi Center Trial (2 years) N=79

Clinically Safe & Effective

• Minimal risk of adverse events

• Patients satisfied with treatment 86%

• Patients can consume reflux causing 60-80% foods without symptoms

                      

                      

                      

                      

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• 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.

Effectiveness - Conclusions