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For treating hypertension
The Symplicity Spyral™ renal denervation system complements medication and lifestyle changes with an effective, evidence-based procedural approach to hypertension treatment.¹⁻⁴
The Symplicity Spyral renal denervation system:
In the SPYRAL HTN-ON MED pilot study, at three years, blood pressure reductions with the Symplicity blood pressure procedure were present throughout the day and night, including the high-risk zone in the late night and early morning period, which is usually associated with increased risk for stroke and cardiovascular events.3
Symplicity Spyral Renal Denervation Procedure - (03:22)
Seen how the Symplicity Spyral renal denervation procedure works to help treat hypertension.
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Watch a short animation that explains the mechanism of action for RF renal denervation with the Symplicity Spyral system.
In typical uncontrolled hypertension patients.
ANCOVA adjusted; secondary efficacy analysis.
RDN arm reduction from baseline.
Includes Symplicity Spyral™ and Flex™ catheters.
Böhm M, Kario K, Kandzari DE, et al. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. The Lancet. 2020;395:1444–1451.
Kandzari DE, Böhm M, Mahfoud F, et al. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. The Lancet. 2018;391(10137):2346–2355.
Mahfoud F, Mancia G, Schmieder R, et al. Three-year safety and efficacy in the Global Symplicity Registry: Impact of antihypertensive medication burden on blood pressure reduction. Presented at PCR e-course 2020.
Mahfoud F, Kandzari DE, Kario K, et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. The Lancet. 2022;399:1401–1410.
Coates P, Tunev S, Trudel J, et al. Time, temperature, power, and impedance considerations for radiofrequency catheter renal denervation. Cardiovascular Revascularization Medicine. 2022.
Medtronic Data on File.
Medtronic Symplicity Spyral™ Instructions for Use.