FDA clears Given capsules for younger children
The capsules were previously indicated for patients 10 years and older.
Yokne'am-based Given said the FDA cleared its PillCam SB video capsules and Agile patency capsules for use in patients two years of age and older. Previously PillCam SB and Agile were indicated for children 10 years and older. PillCam SB is cleared for the visualization of the small bowel mucosa and may be used as a tool for the detection of abnormalities of the small bowel.
"Young children who present with GI issues are often our most challenging cases since many of them must undergo several diagnostic procedures, often without a definite diagnosis," said A. Fritscher-Ravens, Department of Interdisciplinary Endoscopy, University Hospital Kiel, Germany. "Through our studies we have found that only with capsule endoscopy can we visualize the small bowel sufficiently to reach a diagnosis and treat the underlying cause of their symptoms."
Dr. Stanley Cohen of the Children's Center for Digestive Healthcare in Atlanta, Georgia said, "research shows that small bowel capsule endoscopy helps improve outcomes and enable better medical decisions through more effective diagnosis of pediatric patients' gastrointestinal issues."
Given Imaging president and CEO Homi Shamir said, "The needs of these patients are often overlooked, but they represent a very important group for whom accurate diagnosis and effective treatment can impact their lives significantly."
PillCam capsule endoscopes are ingestible video capsules that enable physicians to visualize distinct portions of the GI tract. The Agile patency capsules confirm that the gastrointestinal tract is not blocked, and are used before the PillCam is ingested.
Shares in Given were up 0.47% to $14.98 on Nasdaq in morning trading.
Published by Globes [online], Israel business news - www.globes-online.com - on October 1, 2009
© Copyright of Globes Publisher Itonut (1983) Ltd. 2009
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