Medtronic issues statement on the FDA Circulatory Systems Devices Advisory Panel vote for the Symplicity Spyral Renal Denervation System

August 24, 2023- 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.

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.

The Medtronic SPYRAL HTN Global Clinical Program is the most comprehensive clinical program studying RDN for more than 10 years in more than 4,000 patients in the presence and absence of medication, and with high baseline cardiovascular risk.

Learn More

safe online pharmacy for viagra cheap kamagra oral jelly online