SYMPLICITY SPYRAL™ RENAL DENERVATION (RDN) SYSTEM
Setting the standard in renal denervation
The Symplicity Spyral renal denervation (RDN) system is used during the Symplicity™ blood pressure procedure — the first catheter-based approach using radiofrequency (RF) energy that complements medications and lifestyle modifications to help reduce blood pressure.
The Symplicity Spyral renal denervation system complements medication and lifestyle changes with an effective, evidence-based procedural approach to hypertension treatment.1–4
How renal denervation with Symplicity Spyral works:
- Supplies precisely controlled and targeted radiofrequency energy to the renal nerves5
- Safely disrupts the overactive sympathetic signaling between the kidneys and brain to reduce blood pressure5
>25,000
Patients treated globally with the Symplicity RDN system10.
System components
Symplicity Spyral multi-electrode renal denervation catheter
- One catheter size fits vessels 3–8 mm.6
- 4 F catheter,* compatible with 6 F guide catheter, 0.014" guidewire.
- Easy-to-use, plug-and-play design.
- Nonocclusive design allows for continuous blood flow to naturally protect the vessel wall.5
- Multi-electrode, helical design covers four quadrants simultaneously for a circumferential ablation.5
Symplicity G3™ renal denervation RF generator
- Unique, real-time, and responsive algorithm automatically adjusts power by monitoring temperature and impedance for safe energy distribution5
- Multi-electrode, helical design covers four quadrants simultaneously for a circumferential ablation5,6
- Radiofrequency energy preferentially heats fat tissue where renal nerves are located and avoids nontarget structures7
- Only the Symplicity Spyral RDN system allows for denervation throughout the renal anatomy, including the distal branches,6 where late arriving nerves are accessible and total nerve density is highest8,9
The science of renal denervation
Extensive clinical evidence
The Symplicity Spyral system is proven to achieve safe and clinically meaningful blood pressure reduction in multiple clinical trials and a real-world patient registry.1-4
Take action on hypertension
Gain access to training, education, and tools to successfully introduce the Symplicity Spyral system to your referring community and patients.
Listen to the experts
Find links to third party education sites and view recorded sessions from global RDN experts.
*
Catheter dimension of 0.052" is average maximum diameter determined during design verification. Upper bound allowable is 0.061".
References
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. Lancet. 2020;395:(10234):1444–1451.
2
Mahfoud F, et al. Outcomes following radiofrequency renal denervation according to antihyptensive medications: subgroup analysis of the Global SYMPLICITY Registry DEFINE. EuroPCR 2023.
3
Kandzari DE, Townsend RR, Kario K, et al. Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications. J Am Coll Cardiol. November 7, 2023;82(19):1809–1823.
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. Lancet. April 9, 2022(10333):1401–1410.
5
Coates P, Tunev S, Trudel J, Hettrick DA. Time, temperature, power, and impedance considerations for radiofrequency catheter renal denervation. Cardiovasc Revasc Med. September 2022;42:171–177.
6
Medtronic Symplicity SpyralTM multi-electrode renal denervation catheter Instructions for Use.
7
Sato Y, Sharp A, Mahfoud F, et al. Translational value of preclinical models for renal denervation: a histological comparison of human versus porcine renal nerve anatomy. EuroIntervention. February 6, 2023;18(13):e1120–e1128.
8
García-Touchard A, Maranillo E, Mompeo B, Sañudo JR. Microdissection of the Human Nervous System: Implications for Performing Renal Denervation Procedures. Hypertension. October 2020;76(4):1240–1246.
9
Struthoff H, Lauder L, Hohl M, et al. Histological examination of renal nerve distribution, density, and function in humans. EuroIntervention. September 18, 2023;19(7):612–620.
10
Medtronic data on file. RDN Catheter Historical Data, June 2023. Data includes both Symplicity Flex and Symplicity Spyral.
11
Mahfoud F, Mancia G, Schmieder RE, et al. Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE. Hypertension. 2023;80(8):1759-1770.
