Medtronic Hopes To Refine Renal Denervation Hypertension Therapy With New Trial
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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Medtronic says that most of the clinical trials it is sponsoring are paused due to the pandemic, which means the completion of its PMA application for the Symplicity Spyral renal denervation system will be delayed.
Three-month results of the SPYRAL HTN-OFF MED pivotal trial show renal denervation with Medtronic’s Symplicity Spyral system significantly reduced blood pressure in hypertensive patients not taking anti-hypertensive medications.
FDA is looking forward to reviewing PMAs from several anti-hypertension devices in the coming years – including technologies from Medtronic, ReCor Medical, ROX Medical, and Vascular Dynamics – so the agency convened its Circulatory System Devices Panel on Dec. 5 to get recommendation on pre-market clinical trial design, post-approval study design, indications and labeling for such devices.