BIOTRONIK SE & Co.KG Expansion Of Promri® Clinical Trial Receives FDA Approval
11/21/2013 10:47:07 AM
LAKE OSWEGO, Ore.--(BUSINESS WIRE)--BIOTRONIK, a leading manufacturer of cardiovascular medical devices, announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of their ongoing ProMRI® trial. The just-completed Phase A of the trial evaluated the safety of BIOTRONIK’s current pacemaker systems during magnetic resonance imaging (MRI) scans excluding chest and thorax scan areas. Now Phase B of the trial, just approved by the FDA, will evaluate the same pacemaker system during MRI scans without exclusion zones.
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