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Medtronic Completes PMA Application For Symplicity Spyral Hypertension Device

 
• By Reed Miller

The six-month results from SPYRAL HTN ON MED trial of Medtronic’s Symplicity Spyral renal denervation system did not meet its primary endpoint, but the company and analysts expect the FDA will still approve Symplicity Spyral as the first renal denervation system available in the US to treat uncontrolled hypertension.

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Medtronic is confident the US Food and Drug Administration will approve its Symplicity Spyral radiofrequency renal denervation system to treat uncontrolled hypertension, even though one of the pivotal trials supporting the system missed its primary endpoint.

Medtronic submitted the fifth and final module of the Symplicity Spyral premarket approval application package to the FDA on 7 November, Jason Weidman, president of Medtronic’s coronary and

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