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Medtronic Hopes To Refine Renal Denervation Hypertension Therapy With New Trial

Executive Summary

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 Pushes Completion Of Pivotal Renal Denervation Trial To Late 2022

The company announced that results from the pivotal SPYRAL HTN-ON MED trial of its Symplicity renal denervation system will not be available until the trial completes enrollment next year. The company previously expected to be able to present favorable interim results from the trial in November.

Approval Of Medtronic’s Renal Denervation System Delayed By COVID-19

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.

ACC 2020: SPYRAL HTN-OFF MED Results Support Medtronic’s Renal Denervation System

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.

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