Symplicity Spyral™ renal denervation system
for hypertension
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.
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
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
Sham control
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 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
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.
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.