Medtronic: AdComm Barely Nixes Symplicity Spyral Renal Denervation System

 Today, Medtronic announced the outcome of the U.S. Food & Drug Administration (FDA) Circulatory System Devices Panel (CSDP) meeting to review data presented in support of the Medtronic Symplicity Spyral™ Renal Denervation (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 (tied at 6-6 and one abstention), with the panel chair breaking the tie, resulting in a final 6-7 vote.

"We appreciate the robust conversation that occurred prior to the vote," said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business, which is part of the Cardiovascular Portfolio at Medtronic. "We will continue to collaborate with the FDA on bringing a new option to the millions of people living with high blood pressure."

https://www.biospace.com/article/releases/medtronic-issues-statement-on-the-fda-circulatory-systems-devices-advisory-panel-vote-for-the-symplicity-spyral-renal-denervation-system/