Medtronic Gatekeeper
This article was originally published in The Gray Sheet
Executive Summary
144-patient, randomized, pivotal study will examine gastroesophageal reflux repair system's ability to improve GERD symptoms and reduce need for medication. The company's Bravo pH monitoring system will be incorporated in the trial. In May, Medtronic announced CE mark approval for Gatekeeper (1"The Gray Sheet" May 26, 2003, In Brief)...
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European acid reflux repair system market launch will commence in coming weeks, firm says May 20 after receiving CE mark authorization. U.S. feasibility trials are completed for the endoscopic delivery system/lower esophageal sphincter prostheses, which will target an estimated 375 mil. patients worldwide. Pivotal trials with 12-month follow up will begin this summer, Medtronic says...
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