Symplicity Spyral™ renal denervation system
for hypertension
The Symplicity Spyral renal denervation (RDN) system complements medications and lifestyle modifications for the treatment of hypertension.
Overview
Introducing a procedure to treat hypertension
During the Symplicity™ blood pressure procedure, an interventionalist uses the Symplicity Spyral RDN system to supply precisely controlled and targeted RF energy to the renal nerves, safely disrupting the overactive sympathetic signaling between the kidneys and brain to help reduce blood pressure.1
25,000 patients around the globe have been treated with the Symplicity RDN system.2
Proven to deliver significant, safe, and sustained blood pressure reductions3–6
- Multiple randomized, sham-controlled clinical trials
- Real-world experience with more than 4,000 patients enrolled in the global clinical program*†3–5
Results may vary.
System components
Symplicity Spyral™ multi-electrode renal denervation catheter
- One catheter size fits vessels 3–8 mm1
- 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 wall7
Symplicity G3™ renal denervation RF generator
- Unique, real-time, and responsive algorithm automatically adjusts power by monitoring temperature and impedance for safe energy distribution7
- Multi-electrode, helical design covers four quadrants simultaneously for a circumferential ablation1,7
- Radiofrequency energy preferentially heats fat tissue where renal nerves are located and avoids nontarget structures8
- Only the Symplicity Spyral RDN system allows for denervation throughout the renal anatomy, including the distal branches,1 where late arriving nerves are accessible and total nerve density is highest9,10
Ordering information
Contact your Medtronic sales representative to discuss availability.
| Catalog number |
Description |
|---|---|
| RDN016 |
Symplicity Spyral multi-electrode RDN catheter |
| RDNG3A |
Symplicity G3 generator • supplied standard with remote control |
| RDN019 |
Mobile cart for Symplicity G3 generator (optional accessory) |
| SB6RDND1K |
Sherpa NX™ Balanced 6F 55 cm guide catheter with RDND1 curve |
| LA6IMAK |
Launcher™ 6F 55 cm guide catheter with IMA curve |
| SB6IMAK |
Sherpa NX™ Balanced 6F 55 cm guide catheter with IMA curve |
| E7507 E7507DB |
Dispersive electrode for RDNG3A: Compatible with Covidien ValleyLab Polyhesive™ adult patient return electrode |
Resources
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The Symplicity Spyral RDN system is backed by multiple sham-controlled trials and a real-world registry.
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*
Includes Symplicity Spyral and Flex™ catheters.
†
Study follow-up is ongoing. Data does not represent follow-up for all patients.
‡
Catheter dimension of 0.052" is average maximum diameter determined during design verification. Upper bound allowable is 0.061".
References
1
Medtronic Symplicity Spyral multi-electrode renal denervation catheter instructions for use.
2
Based on internal RDN catheter historical data. June 2023. Data includes both Symplicity Flex and Symplicity Spyral.
3
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.
4
Kandzari D, Townsend R, Kario K, et al. Safety and efficacy of renal denervation in patients taking antihypertensive medication. J Am Coll Cardiol. 2023;82(19):1809–1823.
5
Mahfoud F, Mancia G, Schmieder R, et al. Outcomes following radiofrequency renal denervation according to antihypertensive medications: subgroup analysis of the Global SYMPLICITY Registry DEFINE. EuroPCR 2023.
6
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. 2022;399(10333):1401–1410.
7
Coates P, Tunev S, Trudel J, Hettrick DA. Time, temperature, power, and impedance considerations for radiofrequency catheter renal denervation. Cardiovasc Revasc Med. 2022;42:171–177.
8
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. 2023;18(13):e1120–e1128.
9
García-Touchard A, Maranillo E, Mompeo B, Sañudo JR. Microdissection of the Human Nervous System: Implications for Performing Renal Denervation Procedures. Hypertension. 2020;76(4):1240–1246.
10
Struthoff H, Lauder L, Hohl M, et al. Histological examination of renal nerve distribution, density, and function in humans. EuroIntervention. 2023;19(7):612–620.