Clinical
A Large and Untreated GERD population
Gastroesophageal reflux disease (GERD) is a medical condition affecting hundreds of millions of patients worldwide and approximately 30 million patients in the US alonei. Characterized by the reflux of gastric contents from the stomach into the esophagus, GERD is primarily caused by a hypotensive Lower Esophageal Sphincter (LES) or by transient LES relaxation (tLESR). Typical symptoms and complications of GERD include heartburn, regurgitation, chest pain, dysphagia, chronic cough, and hoarseness. In more serious cases GERD can cause bleeding, stricture formation, Barrett's esophagus and esophageal cancer.
Of the 30 million US sufferers of GERD, nearly 40% (12 million people) are considered refractory because they continue to have symptoms despite standard PPI treatmentii. Most refractory GERD patients either have non-acid or weakly acidic GERD or nocturnal GERD; neither are well controlled by maximal dose PPI therapy. These patients currently have no good solution and most continue to suffer from GERD symptoms. Surgical intervention for refractory GERD is typically reserved for a small minority of patients; less than1% of these 12 million refractory patients eventually undergo surgical treatmentiii. The standard of care surgical treatment (Nissen Fundoplication) is invasive, creates a permanent change in anatomy and has poor long term outcomesiv. It therefore remains a very operator skill dependent procedure. Drug therapy has been widely accepted as the solution of choice for most non-refractory GERD patients; however, growing concerns about long term safety of these drugs is driving patients and physicians to look for alternate treatment optionsv.
Over the last decade a variety of GERD devices have attempted to address GERD, using less invasive techniques, intended to create a mechanical constriction of the LES. To a large extent these attempts were unsuccessful in providing a safe and effective GERD therapy and have been taken off the market. The efficacy of newer GERD devices, applying comparable principle of mechanical constriction of the LES, remains to be determined.
iAlimentary Pharmacology and Therapeutics, 2008 28 (7); 841 - 853
iiAmerican Gastroenterological Association. Gerd Patient Study: Patients and Their Medications. Harris Interactive Inc; 2008.
iiiTalamini, Advanced Therapy in Minimally Invasive Surgery, 2006, Walsworth Publishing Co, Lawiston NY; pp 111
ivLundell et al. Clin Gastro Heaptol 2009; 1292
vYang et al. JAMA. 2006; 296 (24): 2947-2953
Clinical Timeline: EndoStim LES Stimulator.
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