Overview
A novel intervention for hypertension treatment
The Symplicity Spyral renal denervation system:
- Supplies precisely controlled and targeted radiofrequency (RF) energy to the renal nerves
- Safely disrupts the overactive sympathetic signaling between the kidneys and brain to reduce blood pressure5
Proven to reduce blood pressure1
The Symplicity Spyral system delivers clinically significant, safe, and sustained blood pressure reductions in multiple clinical trials and a real-world patient registry.1-4
Supported by published clinical evidence unmatched in scope, quantity, and quality
Always-on blood pressure reduction
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
Performance for simplicity and versatility
See the procedure in action
Learn how the Symplicity Spyral system provides a simple, safe, and effective approach to reducing hypertension.1-4
One catheter size fits all eligible anatomy
- Single catheter treats a wide range of anatomy (vessels 3–8mm in diameter)6,7
- Utilizes a helical electrode pattern to ablate all four vessel quadrants simultaneously
- Enables ablation of the main artery, accessory, and branch vessels to maximize the probability of complete denervation6,7
- Easy-to-use, rapid exchange, plug-and-play design
Explore the science of RDN
Watch a short animation that explains the mechanism of action for RF renal denervation with the Symplicity Spyral system.
Symplicity G3™ renal denervation RF generator
The Symplicity G3 generator employs a real-time responsive algorithm that controls and monitors the safe distribution of energy to target nerves.6
*
In typical uncontrolled hypertension patients.
†
ANCOVA adjusted; secondary efficacy analysis.
‡
RDN arm reduction from baseline.
§
Includes Symplicity Spyral™ and Flex™ catheters.
1
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.
2
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.
3
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.
4
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.
5
Coates P, Tunev S, Trudel J, et al. Time, temperature, power, and impedance considerations for radiofrequency catheter renal denervation. Cardiovascular Revascularization Medicine. 2022.
6
Medtronic Data on File.
7
Medtronic Symplicity Spyral™ Instructions for Use.