The FDA has approved the second renal denervation device in the agency's history with the approval of Medtronic's Symplicity Spyral system.
Coming just 10 days after the FDA approved the first renal denervation device in the agency’s history for a similar indication, the approvals usher in a new era in the management of hypertension.1,2
“In combination with medication and lifestyle changes, renal denervation opens the door to manage high blood pressure in the long term through a safe and effective procedure. It’s absolutely exciting to think about how this complementary therapy can help treat the problem of high blood pressure for many more people,” said David Kandzari, MD, chief of the Piedmont Heart Institute and chief scientific officer of Piedmont Healthcare, in a statement from Medtronic.1
The approval of the Medtronic Simplicity Spyral renal denervation system is the culmination of a 14-year journey, which included a breakthrough device designation in 2020 and also mixed reviews in an advisory committee vote in August 2023.1
The subject of an August 23, 2023 meeting of the FDA’s Circulatory System Devices Panel, the committee voted 13-0 on the safety of Medtronic’s Symplicity Spyral RDN System, but was split at 6-7 against the effectiveness of the device. Just a day earlier, on August 22, 2023, the same panel had voted 12-0 in favor of the Recor Paradise Ultrasound system for safety and 8-3 in favor of efficacy. Following these votes, the Society for Cardiovascular Angiography and Interventions released a position statement endorsing the potential of renal denervation as adjuncts to abate or interventions to abolish hypertension.3
According to the release from Medtronic announcing approval, manufacturing of the device for US distribution is already underway and the company hopes to make it widely available soon.1
“This launches a new frontier in the fight against high blood pressure,” said Jason Weidman, president of the Coronary and Renal Denervation business at Medtronic.1 “Especially for the many patients whose hypertension doesn’t respond to drugs, or for people who struggle to keep up with their drug regimen, Symplicity Spyral has the potential to make a major difference in their lives.”