Medtronic issues statement on FDA AdCom vote on RDN System

Medtronic “announced the outcome of the FDA Circulatory System Devices Panel meeting to review data presented in support of the Medtronic Symplicity Spyral(TM) Renal Denervation, or RDN, System. The panel Committee voted unanimously, 13-0, on safety and in favor (7-6) of the effectiveness of the Symplicity blood pressure procedure. The Committee’s vote was closely divided on the benefit/risk profile of the device, with the panel chair breaking the tie, resulting in a final 6-7 vote. The CSDP is designed to review and evaluate data regarding the safety and effectiveness of devices for use in the circulatory and vascular systems and make appropriate recommendations to the FDA Commissioner. The panel recommendation will be considered by the FDA as it continues to review the Medtronic Symplicity Spyral RDN System for U.S. market approval.”