Medtronic, Inc. (NYSE: MDT) announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) allowing the company to initiate SYMPLICITY HTN-4, the first randomized trial to investigate renal denervation for the treatment of moderate uncontrolled hypertension in U.S. patients. The study will evaluate the Symplicity(TM) renal denervation system in patients with moderate uncontrolled hypertension (systolic blood pressure greater than or equal to 140 and less than 160 mm Hg, despite treatment with three or more anti-hypertensive medications of different classes). SYMPLICITY HTN-4, which enrolled its first patient at Duke University Medical Center, is Medtronic's second randomized, controlled renal denervation clinical trial in the United States. The Symplicity renal denervation system is currently available only for investigational use in the United States.
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