Renal denervation for hypertension

SPYRAL HTN global clinical trial program

The Symplicity™ blood pressure procedure has demonstrated clinically significant and safe blood pressure reductions in randomized controlled trials (RCTs).1,2

Significant and safe blood pressure reductions

  • > 4,000 patients enrolled in the global clinical program†,‡,1–3
  • > 9 mmHg reduction in OSBP in patients off and on medications1,2
  • < 0.4% major adverse events rate at composite endpoint, including no new incidence of renal artery stenosis (> 70%) at 6 months2
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Significant reductions

Safe procedure

  

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
Learn about the procedure

The Symplicity™ blood pressure procedure is changing how patients with hypertension can reduce their blood pressure.

Real-world results

See data from the Global SYMPLICITY Registry, the largest renal denervation dataset.

Take action on hypertension

Gain access to resources to introduce the Symplicity™ blood pressure procedure to your community successfully.

Find education resources

Discover a wide range of educational content about the Symplicity™ blood pressure procedure, from links to third party education sites to recorded sessions from global RDN experts.

† Study follow-up is ongoing. Data does not represent follow-up for all patients.

‡ Includes Symplicity Spyral™ and Flex catheters.

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, et al. Outcomes following radiofrequency renal denervation according to antihyptensive medications: subgroup analysis of the Global SYMPLICITY Registry DEFINE. EuroPCR 2023.

4. CSDP sponsor executive summary: Symplicity Spyral™ renal denervation system. Medtronic. Available at: www.fda.gov/media/171412/download. Accessed on November 17, 2023.

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