Medtronic Completes PMA Application For Symplicity Spyral Hypertension Device

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 renal denervation...