Your browser is out of date

With an updated browser, you will have a better Medtronic website experience. Update my browser now.

×

Skip to main content

Clinical evidence

Read on to understand our extensive clinical evidence and sign up for email to receive the latest resources.

Contact us
Alert Indications, Safety, and Warnings

The  Symplicity Spyral™ renal denervation system, which is used during the Symplicity™ procedure, is backed by multiple sham-controlled trials and the largest real-world registry. The SPYRAL HTN clinical program is the largest renal denervation clinical program, studying more than 5,000 patients worldwide.†,‡,1–3

Significant, safe, and sustained blood pressure reductions

The Symplicity Spyral™ system is proven to deliver significant, safe, and sustained blood pressure reductions.1–5
Significant

> 9 mmHg

mean reduction in office systolic blood pressure (SBP) in patients on and off medications at primary endpoint follow-up in multiple clinical trials1,2

Safe

< 0.4%

major adverse events at composite endpoint, including no new incidence of renal artery stenosis
(> 70%) at 6 months.2
(N = 253)

Sustained

17 mmHg

mean reduction in office SBP in real-world patients at three years with the Symplicity™ renal denervation catheter.†,4
(N = 1,337)

Download clinical summary

Reduced blood pressure in the presence and absence of medication

Multiple randomized, sham-controlled trials show blood pressure reductions in the presence and absence of medication following use of the Symplicity Spyral™ system.1,2

 

Navy blue and blue gradient bar chart showing the levels of blood pressure in the presence and absence of medication
 
Read on to learn more about the SPYRAL HTN clinical program, including:
Expand All

SPYRAL HTN-OFF MED Trial

SPYRAL HTN-ON MED Trial

Global SYMPLICITY™ Registry (GSR-DEFINE)

Our body of evidence continues to grow.

SPYRAL AFFIRM Global Study

Now enrolling the post-approval study at sites across the United States.

Learn more

See how renal denervation can help.

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

View details

View product details.

Learn about Symplicity Spyral™ RDN system’s components and their role in the Symplicity™ blood pressure procedure.

View product details

Learn from the experts on YouTube

Visit our YouTube channel for symposium replays, expert insights, and practical discussions from leading European specialists.

Visit now

Read the manuscripts

Related pages

Sign up for email to stay connected.

We want to provide you with resources that will be the most useful as you acquaint yourself with this procedure.

Sign up so we can send relevant information and resources directly to your inbox.

  

Contact us

*Indicates Required Field

Your information will be processed and protected in accordance with our privacy statement

Selecting “no” to marketing emails above will not affect your other email selections, and a Medtronic representative will still reach out via email, if selected. Your personal data will used to manage your relationship with Medtronic, and, if you consent, to provide you with relevant email updates based on your user preferences. You can opt-out of receiving such emails at any time by clicking the unsubscribe link in the relevant email. Medtronic may use pixels and other technologies in emails to gather statistics around email opening and clicks, to help us improve our communications and to provide you with relevant content. For more information, see the Medtronic privacy notice.

You can always change your preferences or update your personal details by visiting the Preference center.

See the Preference center

Contact us

*Indicates Required Field

Your information will be processed and protected in accordance with our privacy statement

Selecting “no” to marketing emails above will not affect your other email selections, and a Medtronic representative will still reach out via email, if selected. Your personal data will used to manage your relationship with Medtronic, and, if you consent, to provide you with relevant email updates based on your user preferences. You can opt-out of receiving such emails at any time by clicking the unsubscribe link in the relevant email. Medtronic may use pixels and other technologies in emails to gather statistics around email opening and clicks, to help us improve our communications and to provide you with relevant content. For more information, see the Medtronic privacy notice.

You can always change your preferences or update your personal details by visiting the Preference center.

See the Preference center

a) Statement “Registered under Act 737” 
b) Medical device registration number: GC3639922-85853
† Includes Symplicity Spyral™ and Flex RDN catheters.
‡ Study follow-up is ongoing. Data does not represent follow-up for all patients.

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. doi: 10.1016/S0140-6736(20)30554-7.

2

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.

3

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):1759–1770. doi: 10.1161/HYPERTENSIONAHA.123.21283.

4

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. EuroPCR 2023.

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

Based on Global SYMPLICITY Registry clinical data snap. 2023. Medtronic data on file.

7

Kandzari D, Mahfoud F, Townsend R, et al. Durable safety and efficacy of renal denervation using the Symplicity Spyral catheter in patients taking antihypertensive drugs: final, 3-year results from the SPYRAL HTN-ON MED randomized study. Presented at: TCT 2025; October 25–28, 2025; San Francisco, CA