FDA Panel Rejects Medtronic's Symplicity Spyral RDN

An FDA review panel has voted against recommending approval of Medtronic's Symplicity Spyral renal denervation (RDN) therapy for hypertension, stating that the risks outweigh the benefits. While the panel unanimously agreed that the catheter system is safe, they were divided on its efficacy. The panel chair cast the deciding vote against FDA approval. Medtronic's RDN trials have failed to meet the primary endpoint for efficacy, but the company remains hopeful and will work with the FDA to address the panel's concerns. The FDA review panel also supported the approval of a competing RDN technology developed by ReCor Medical.