Given Imaging Ltd., a company focused in developing and marketing patient-friendly solutions for visualizing and detecting disorders of the GI tract, revealed that the U.S. Food and Drug Administration (FDA) has cleared use of its Bravo pH Monitoring System in patients four years of age and older.
"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," Homi Shamir, president and chief executive officer, Given Imaging Ltd., said in a statement.
"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 percent of patients preferring Bravo to catheter-based tests due to less discomfort in daily living," Shamir added.
This revised labeling is believed to enable physicians to use the Bravo pH system to measure gastro esophageal pH and monitor gastric reflux in this important patient population.
Moreover, 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 gastro esophageal 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," Brian E. Lacy, Dartmouth-Hitchcock Medical Center said in a statement.
"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," Hitchcock added.
The Bravo pH Monitoring System is a wireless, catheter-free, 48-hour pH test commercially available for pH testing to assess gastro esophageal reflux disease (GERD). The system is said to collect data that are more reflective of the patient's normal daily routine to assess if the patient has GERD.
Jai C.S. is a contributing editor for HealthTechZone. To read more of Jai's articles, please visit his columnist page.Edited by
Charles West
