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BioWorld - Monday, March 23, 2026
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Home » Divergent trial results tank Medtronic’s Symplicity Spyral at FDA advisory
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Divergent trial results tank Medtronic’s Symplicity Spyral at FDA advisory

Aug. 24, 2023
By Mark McCarty
Dublin-based Medtronic plc. has invested considerable resources into its renal denervation program, but the company has not completed its regulatory journey for the U.S. market just yet. Medtronic failed to persuade an FDA advisory committee of the virtues of its Symplicity Spyral device due to inconsistent results from the two major studies presented at the hearing but vowed to keep working on the application despite the sustained headwinds.
Medical technology Regulatory Cardiovascular U.S. FDA

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