Medtronic Releases Details On New Renal Denervation Trials
This article was originally published in The Gray Sheet
FDA has granted an investigational device exemption for the SPYRAL HTN renal denervation global clinical trial program, designed to avoid the problems that led Medtronic's prior pivotal study to miss its endpoint.
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The 50-patient SPYRAL DYSTAL trial will evaluate the benefits of a new targeted renal denervation approach with the Symplicity Spyral renal denervation system in patients with uncontrolled hypertension.
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