Core Concepts
The Symplicity Spyral Renal Denervation System's efficacy is debated by the FDA panel, with concerns about its effectiveness outweighing its benefits.
Abstract
The FDA's Circulatory System Devices Panel voted on the safety and efficacy of the Symplicity Spyral Renal Denervation System by Medtronic. The panel was split on the device's efficacy, with concerns about whether its benefits outweigh the risks. The device uses radiofrequency energy to denervate renal arteries for patients with uncontrolled hypertension. Studies showed mixed results, with varying effectiveness in reducing blood pressure. Panel members had differing opinions on the device's efficacy, with some emphasizing the need for more selective indications and additional data to support its use.
Stats
The panel voted 13 to 0 that the Symplicity Spyral Renal Denervation System is safe.
The panel voted 7 to 6 that the system is effective.
The panel voted 6 to 6 that the benefits outweigh the risks.
Quotes
"We appreciate the robust conversation that occurred prior to the vote." - Jason Weidman, Medtronic
"The totality of the evidence demonstrated that there is a benefit with the SPYRAL RDN catheter." - David Kandzari, Piedmont Heart Institute