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

No more pain. No more pills. Get back to living!. 120308. 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

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

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  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. Pulmonary Asthma Aspiration pneumonia Chronic bronchitis Other Regurgitation Chest pain Dental erosion ENT Hoarseness Laryngitis Sore throat Chronic cough Frequent swallowing Burning in the throat or mouth Other Symptoms of GERD 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. Anatomical change and loss of natural antireflux valve Root Cause of Moderate/Severe GERD 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. Severe and Chronic GERD 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 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. 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

  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 < 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) 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

  15. Phase 2 – Dietary Changes Patients can enjoy foods that caused reflux off PPIs *P < 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) N=79 • Minimal risk of adverse events • Patients satisfied with treatment 86% • Patients can consume reflux causing 60-80% foods without symptoms Clinically Safe & Effective

  18. 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

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