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Given Imaging announced that the U.S. Food and Drug Administration FDA recently cleared use of its Bravo pH Monitoring System in patients four years of age and older.

Given Imaging Ltd. (NASDAQ: GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy , announced that the U.S. Food and Drug Administration ( FDA ) recently cleared use of its Bravo pH Monitoring System in patients four years of age and older. The revised labeling enables physicians to use the Bravo pH system to measure gastroesophageal pH and monitor gastric reflux in this important patient population. The Canadian government also cleared the Bravo system for use in patients four years of age and older. Previously, the Bravo pH Monitoring System was indicated for individuals 18 years and older in both countries.

"Pediatric gastroesophageal reflux disease (GERD) affects approximately five percent of all children and adolescents. Previously, to diagnose GERD in pediatric patients we often had to use transnasal catheter-based testing tools. The availability of the Bravo system for these young patients could eliminate a substantial degree of discomfort," said Brian E. Lacy, MD, PhD, Dartmouth-Hitchcock Medical Center. "The Bravo pH capsule is a safe, well-tolerated test to evaluate acid reflux symptoms in children, and the data obtained frequently changes patient management."

"We are pleased to be able to offer some of the youngest patients the most patient-friendly method for assessing pH levels to help in the diagnosis of GERD, a painful condition," said Homi Shamir, President and Chief Executive Officer, Given Imaging Ltd. "In adults, Bravo pH monitoring has been shown to be better tolerated as it is more comfortable and less visible than catheter-based pH tests, with 96% of patients preferring Bravo to catheter-based tests due to less discomfort in daily living(1)."

Source : Given Imaging

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