RF ablation systems

Symplicity Spyral™ renal denervation system

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.

Ordering information
Contact a representative
Indications, Safety, and Warnings

Description

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 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

25,000 patients around the globe have been treated with the Symplicity™ RDN system.4

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

Resources

Stay connected.

Sign up for email so we can send relevant information, education, and resources directly to your inbox.

Sign up now (open in new window)

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.

View the details

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.