Medtronic have presented 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 favour (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."
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 Symplicity Blood Pressure Procedure has the potential to fill a significant unmet need in hypertension care, and we know patients are looking for options in addition to medication and lifestyle modifications to manage their blood pressure," said David Kandzari, M.D., chief, Piedmont Heart Institute and Cardiovascular Services and lead principal investigator of the SPYRAL HTN-ON MED clinical trial. "The totality of evidence demonstrated that there is a benefit with the Spyral RDN catheter, and there is no question about the safety of the procedure."
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. The Symplicity blood pressure procedure has demonstrated sustained and durable drops in blood pressure out to three years in randomised control and real-world registry trials.