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Boston Scientific Receives U.S. FDA Approval For Quadripolar Leads And Initiates Global Trial To Expand MRI Labeling To The U.S. And Asia

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Additional Relevant Details Earlier this month, the company initiated the global ENABLE MRI study, which is intended to support FDA approval for magnetic resonance imaging (MRI) across the company's currently approved implanted cardiac defibrillation (ICD) and CRT systems. The newly approved family of ACUITY X4 Quadripolar LV leads will be used in this study, which is expected to enroll as many as 500 patients at approximately 60 sites worldwide. Trial findings will be submitted to regulatory authorities in Asia and the U.S. when the company requests updated labeling for MRI-conditional use on ICD and CRT systems, including those that have previously been implanted.
http://news.bostonsc...
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Catalyst Date
Occurred on:
Feb 23, 2016
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Related Keywords Acuity X4, Global Trial, Mri Labeling, Quadripolar