RF ablation systems

Symplicity Spyral™ renal denervation system

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RF ablation systems

Symplicity Spyral™ renal denervation system

The Symplicity Spyral™ renal denervation (RDN) system is used during the Symplicity™ blood pressure procedure for the treatment of hypertension.

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Indications, Safety, and Warnings

Description

An interventional procedure to treat hypertension

During the Symplicity™ blood pressure procedure, an interventionalist uses the Symplicity Spyral™ RDN system to supply precisely controlled and targeted radiofrequency (RF) energy to the renal nerves, safely disrupting the overactive sympathetic signaling between the kidneys and brain to help reduce blood pressure.1–3

30,000 patients around the globe have been treated with the Symplicity™ RDN system.4

Features

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See how the system works.

Watch a short video to see how the Symplicity Spyral™ system works during the Symplicity™ procedure.

Symplicity Spyral™ multi-electrode renal denervation catheter

  • One catheter size fits vessels 3–8 mm5
  • 4 F catheter,† compatible with 6 Fr guide catheter, 0.014" guidewire
  • Easy-to-use, plug-and-play design
  • Nonocclusive design allows for continuous blood flow to naturally protect the vessel wall1
This is an image of the Medtronic Symplicity Spyral™ renal denervation catheter with blue gradient spirals circling it.

Symplicity G3™ renal denervation RF generator

  • Unique, real-time, and responsive algorithm automatically adjusts power by monitoring temperature and impedance for safe energy distribution.1
  • Multi-electrode, helical design covers four quadrants simultaneously for a circumferential ablation.1,5
  • Radiofrequency energy preferentially heats fat tissue where renal nerves are located and avoids nontarget structures.‡,6
  • Only the Symplicity Spyral™ RDN system allows for denervation throughout the renal anatomy with a single catheter, including the distal branches,5 where late arriving nerves are accessible and total nerve density is highest.7,8
This is an image of the Symplicity G3™ renal denervation RF generator.

Proven to deliver significant, safe, and sustained blood pressure reductions2,3,9,10

  • Multiple randomized, sham-controlled clinical trials
  • Real-world experience with more than 5,000 patients enrolled in the SPYRAL HTN clinical program§,◊,2,3,10–14
Review all data


Results may vary.

Ordering information

Symplicity Spyral™ system products

Item 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)

 

Additional products used during the Symplicity™ procedure

Item number Description
SB6RDND1K Sherpa NX™ balanced 6 Fr 55 cm guide catheter with RDND1 curve
LA6IMAK Launcher™ 6 Fr 55 cm guide catheter with IMA curve
SB6IMAK Sherpa NX™ balanced 6 Fr 55 cm guide catheter with IMA curve
E7507 and
E7507DB		 Dispersive electrode for RDNG3A: Compatible with ValleyLab Polyhesive™ adult patient return electrode

 

Resources

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Review clinical evidence.

The Symplicity Spyral™ RDN system is backed by multiple sham-controlled trials and a real-world registry.

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See how renal denervation can help.

Learn more about the turning point in hypertension care and how it can help enhance treatment strategies.

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Additional resources

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† Catheter dimension of 0.052" is average maximum diameter determined during design verification. Upper bound allowable is 0.061".

‡ Preclinical data may not be indicative of clinical performance.

§ Includes Symplicity Spyral™ and Flex™ catheters.

◊ Study follow-up is ongoing. Data does not represent follow-up for all patients.

  1. 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. doi:10.1016/j.carrev.2022.02.018.
  2. 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. doi:10.1016/S0140-6736(20)30554-7.
  3. Kandzari D, Townsend R, Kario K, et al. Safety and efficacy of renal denervation in patients taking antihypertensive medications. J Am Coll Cardiol. 2023;82(19):1809–1823. doi: 10.1016/j.jacc.2023.08.045.
  4. Based on RDN catheter historical data, Feb 2025. Data includes both Symplicity™ Flex and Symplicity Spyral™. Medtronic data on file.

  1. Symplicity Spyral™ multi-electrode renal denervation catheter instructions for use. Medtronic. November 18, 2023.
  2. 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. doi:10.4244/EIJ-D-22-00369.
  3. García-Touchard A, Maranillo E, Mompeo B, Sañudo JR. Microdissection of the human renal nervous system: Implications for performing renal denervation procedures. Hypertension. 2020;76(4):1240–1246. doi:10.1161/HYPERTENSIONAHA.120.15106.
  4. 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. doi:10.4244/EIJ-D-23-00264.
  5. 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(10234):1401–1410. doi:10.1016/S0140-6736(22)00455-X.
  6. Mahfoud F, Schlaich M, Schmieder RE, et al. Long-term outcomes in ESC guideline-recommended patients for RDN from Global SYMPLICITY Registry DEFINE. Presented at: EuroPCR 2025; May 20–23, 2025; Paris, France.
  7. Kario K, Ogawa H, Okumura K, et al. SYMPLICITY HTN-Japan - First randomized controlled trial of catheter-based renal denervation in Asian patients -. Circ J. 2015;79(6):1222–1229. doi:10.1253/circj.CJ-15-0150.
  8. Bhatt DL, Kandzari DE, O’Neill WW, et al. A controlled trial renal denervation for resistant hypertension. N Engl J Med. 2014;370(15):1393–1401. doi:10.1056/NEJMoa1402670.
  9. Esler MD, Böhm M, Sievert H, et al. Catheter-based renal denervation for treatment of patients with treatment-resistant hypertension: 36 month results from the SYMPLICITY HTN-2 randomized clinical trial. Eur Heart J. 2014;35(26):1752–1759. doi:10.1093/eurheartj/ehu209.
  10. Krum H, Schlaich MP, Sobotka PA, et al. Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study. Lancet. 2014;383(9917):622–629. doi:10.1016/S0140-6736(13)62192-3.