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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

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No more pain. No more pills.

Get back to living!

120308


Symptoms of gerd l.jpg
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


Other symptoms of gerd l.jpg

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


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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


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Anatomical change and loss of natural antireflux valve

Root Cause of Moderate/Severe GERD

Normal AnatomyFully Functional Valve Prevents Reflux

Abnormal Dysfunctional ValveGERD


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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


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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


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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


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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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GERD Treatment Options chronic drug therapy

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


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EsophyX TIF chronic drug therapy

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 chronic drug therapy

Unique Surgical Approach


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EsophyX Experience chronic drug therapy

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) chronic drug therapyN=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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Phase 2 – Dietary Changes chronic drug therapy

Patients can enjoy foods that caused reflux off PPIs

*P < 0.01


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Phase 2 – Dietary Changes chronic drug therapy

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


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Multi Center Trial (2 years) chronic drug therapyN=79

  • Minimal risk of adverse events

  • Patients satisfied with treatment 86%

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

Clinically Safe & Effective


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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


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