FDA Approves Medtronic's Symplicity Spyral for Hypertension

A recent Medscape article noted the FDA’s approval of Medtronic's Symplicity Spyral renal denervation system to treat hypertension. The catheter-based approach uses radiofrequency energy to denervate the renal arteries. The FDA's Circulatory System Devices Panel previously deemed the system safe in August, though opinions were divided on its efficacy and risk-benefit profile. 

As part of the Medtronic SPYRAL HTN Global Clinical Program, over 25,000 patients worldwide were treated, showing a significant reduction in ambulatory systolic blood pressure. The approval is seen as an important step toward treating hypertension, in addition to medication and lifestyle changes.