Cardio Catch-Up: Medtronic Still Has Work To Do On RDN After FDA Advisory Panel

31 Aug 2023

FDA’s circulatory system advisory panel narrowly voted against Medtronic’s Symplicity Spyral, because one of the pivotal trials of the radiofrequency renal denervation system missed its primary endpoint and the patient population evaluated in the trial does not match the requested indication.

Medtronic’s long struggle to launch its Symplicity Spyral renal denervation (RDN) technology on the US market is not going to get any easier following a mixed review by the US Food and Drug Administration’s circulatory system devices advisory panel.

The panel considered the company's premarket approval application (PMA) for Symplicity Spyral on 23 August, one day after it considered...