Symplicity Spyral renal denervation system

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.

  

Symplicity Spyral™ renal denervation catheter

Overview

Turn to a proven approach to treat hypertension.

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
Illustrated brain and illustrated kidneys, with an arrow going between the two to indicate interaction

Clinical evidence

Proven to reduce blood pressure.

The Symplicity Spyral system delivers clinically significant, safe, and sustained blood pressure reductions in multiple clinical trials and a real-world patient registry.1–4

18

mmHg

reduction in OSBP real-world patients at 3 years with the Symplicity Spyral catheter
n = 2676

Supported by published clinical evidence unmatched in scope, quantity, and quality.

> 9 mmHg

reduction in OSBP in patients off and on medications.1,3

> 4,000

patients in the global trial program.*†1–3,7,8

> 25,000

patients treated globally with
the Symplicity RDN system.*9

Always-on blood pressure reduction

RDN demonstrates 24-hour blood pressure lowering effect especially during high-risk nighttime and early morning periods.1

Renal denervation

Graph showing 24-hour blood pressure changes in renal denervation group of SPYRAL HTN-OFF MED trial

Sham control

Graph showing 24-hour blood pressure changes in sham control group of SPYRAL HTN-OFF MED trial

Product performance

Setting the standard in renal denervation.

See the procedure in action.

Learn how the Symplicity Spyral system provides a simple, safe, and effective approach to reducing hypertension.1–4

Explore the science of RDN.

Watch a short animation that explains the mechanism of action for RF renal denervation with the Symplicity Spyral system.

Product specifications 

One catheter size fits all eligible anatomy.

  • One catheter size fits vessels 3–8 mm.10
  • 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 Spyral multi-electrode renal denervation catheter

The Symplicity Spyral catheter offers the ability to navigate complex anatomy.10
Symplicity G3™ renal denervation RF generator

Symplicity G3 renal denervation RF generator

The Symplicity G3 generator employs a real-time responsive algorithm that controls and monitors the safe distribution of energy to target nerves.5

Partners in care

Medtronic can help you build or enhance your hypertension treatment strategies with:

  • Strategic collaboration designed to improve care for patients.
  • Access to world-class referral, training, and education resources.
  • Experienced field and support teams.
Male patient in green shirt sitting at a computer with a male healthcare professional in a lab coat

This material is for Healthcare Professionals in countries with applicable health authority product registrations.

Important: Always refer to the Instructions For Use (IFU) packaged with the product/e-IFU for complete instructions, indications, contraindications, warnings, and precautions. 

*

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

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 data on file. Global Symplicity Registry clinical data snap, March 2023.

7

Townsend RR, Mahfoud F, Kandzari DE, et al. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet. November 11, 2017;390(10108):2160–2170.

8

Kandzari DE, Böhm M, Mahfoud F, et al. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. June 9, 2018;391(10137):2346–2355.

9

Medtronic data on file. RDN Catheter Historical Data, June 2023.

10

Medtronic Symplicity Spyral™ Instructions for Use.