Reflux Control for GERD

What is GERD?

GERD is "a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications"¹. Symptoms are "troublesome" if they adversely affect an individual's wellbeing¹.

How many people are affected by GERD?

Population-based studies suggest that GERD is a common condition with a prevalence of 10-20% in Western Europe and North America². The prevalence rates in South America are similar to European countries and in Asia, the prevalence has been variably reported but is generally lower².

Current Treatment Options

Medication

• Promotility agents which work by accelerating gastric emptying

• H2 Blockers which reduce the amount of acid produced in the stomach and are available over the counter

• Proton Pump inhibitors, which are presecribed medications that work by blocking acid secretion in the stomach

Surgery

Patients who do not respond to medication are referred for treatment through surgical procedures, the most common of which is Nissen Fundoplication. The procedure is usually performed laproscopically and involves wrapping the upper part of the stomach around the esophagus and securing it in place with sutures. This strengthens the LES (Lower Esophageal Sphincter), restoring its function to serve as a barrier for reflux of stomach contents. Long term high dose Proton Pump Inhibitors have been shown to be ineffective to a certain group of patients (known as non-responders) and this group are the main candidates for surgical treatment. The potential benefits of anti-reflux surgery should be weighed against the deleterious effect of new symptoms consequent from surgery, particularly dysphagia, flatulence, an inability to belch and postsurgery bowel symptoms¹. As many as 30% of patients have resumed medical therapy by 5 years after anti-reflux surgery and surgical revision is common¹.

Endoscopic Interventions

Non surgical techniques to enhance the LES function are emerging as viable treatment options for GERD. All are in the early stages of market introduction and none have yet been adopted as the benchmark treatment of choice by the medical community. The American Gastroenterological Association has stated that there is "insufficient evidence to recommend for or against" endolumincal antireflux procedures¹.

Vysera's Solution

The Vysera GERD device provides a unique approach to the problem of chronic GERD; by deploying a device at the area of the malfunctioning LES via a minimally invasive procedure. This procedure is low-risk, reversible and does not permanently alter a patient's anatomy. The Vysera device is manufactured from Vysera's unique technology and when placed in the esophagus, mimics the functionality of a normal sphincter, thereby restoring control of the reflux of stomach contents.

Sources

1. American Gastroenterological Association Medical Position Statement on the management of Gastroesophageal Reflux Disease (2008)

2. The Montreal Definition and Classification of Gastroesophageal Reflux Disease: A Global Evidence Based Consenus (2006)