RF ablation systems

Symplicity Spyral™ renal denervation system

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

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Features

Watch a short video to see how the Symplicity SpyralTM system works during the SymplicityTM procedure.

Symplicity Spyral™ multi-electrode renal denervation catheter

  • One catheter size fits vessels 3–8 mm5
  • 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 wall1

Symplicity G3™ renal denervation RF generator

  • Unique, real-time, and responsive algorithm automatically adjusts power by monitoring temperature and impedance for safe energy distribution1
  • Multi-electrode, helical design covers four quadrants simultaneously for a circumferential ablation1,5
  • 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 highest7,8
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 4,000 patients enrolled in the SPYRAL HTN clinical program§,◊,2,3,11
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

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Review clinical evidence.

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

See the data

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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Similar products

† 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.
  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.
  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.
  4. Based on RDN catheter historical data, 2023. Data includes both Symplicity Flex and Symplicity Spyral. Medtronic data on file.

  1. Medtronic Symplicity Spyral multi-electrode renal denervation catheter and Symplicity G3 generator instructions for use.
  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.
  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.
  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.
  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.
  6. Mahfoud F, et al. Outcomes following radiofrequency renal denervation according to antihyptensive medications: subgroup analysis of the Global SYMPLICITY Registry DEFINE. EuroPCR 2023.
  7. 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):1759–177.