Randomized controlled trials

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Effective with and without medications

The Symplicity blood pressure procedure is effective in the presence and absence of medications.1-3

SPYRAL HTN-ON MED Pilot Study

Results with medications

This study evaluated the effect of the Symplicity blood pressure procedure in the presence of anti-hypertensive drugs.
 
Three-year follow-up

Clinically significant, safe and sustained and safe blood pressure reductions through three years:
  • 18.7 mmHg reduction in 24-hour systolic ambulatory blood pressure (ABPM) for RDN patients vs. baseline (p<0.01)3 
  • 20.9 mmHg reduction in office systolic blood pressure3
  • >80% of patients taking meds achieved SBP <140 mmHg with the Symplicity procedure3
  • Zero device or procedural safety events3
  • Renal denervation did not negatively affect kidney function3
A cover of the Lancet journal featuring three-year data from the HTN-ON MED pilot study.

Long-term safety and efficacy

Prof. Felix Mahfoud presents the SPYRAL HTN-ON MED Pilot Study data at ACC 2022 detailing the long-term safety and efficacy of the Symplicity blood pressure procedure.

24-hour blood pressure lowering effect at three years


In the SPYRAL HTN-ON MED Pilot Study, at three years, blood pressure reductions with the Symplicity blood pressure procedure were present throughout the day and night, including the high-risk zone in the late night and early morning period, which is usually associated with increased risk for stroke and cardiovascular events.3

A chart shows how the Symplicity procedure reduces blood pressure 24 hours a day.

SPYRAL HTN-OFF MED Pivotal Trial

Results without medications

The powered efficacy endpoints for this trial were:
  • Change in 24-hour systolic blood pressure at three months
  • Change in office systolic blood pressure at three months
The trial showed clinically signifcant blood pressure reductions at three months. Specifcally, office systolic blood pressure decreased 9.2 mmHg and 24-hour systolic ambulatory blood pressure decreased 4.7 mmHg.†‡2
A cover of the Lancet journal featuring safety and efficacy data from the HTN-OFF MED Pivotal trial.

Always-on blood pressure reduction

The SPYRAL HTN-OFF MED Pivotal Trial showed that the Symplicity blood pressure procedure had superior blood pressure reductions compared to control at three months. Its blood-pressure-reducing benefts are always on, protecting all day and night, including during the high-risk early hours.

Explore SPYRAL HTN-OFF MED Pivotal Trial data

Watch a presentation from Dr. Michael Böhm analyzing data from the SPYRAL HTN-OFF MED Pivotal Trial.

The next step for the Symplicity procedure

The SPYRAL AFFIRM study will evaluate the long-term safety,
efficacy, and durability of the Symplicity blood pressure procedure.

  • 1,000 patients treated
  • 100 global trial sites
  • 3 high-risk subgroups
  • 3-year follow up
  • 5-year follow-up in up to 200 patients from ON & OFF MED trials
A kidneys icon refers to the fact that Medtronic Renal Denervation treats the renal nerves to reduce blood pressure.

Transforming hypertension treatment

The Symplicity blood pressure procedure is changing how patients with hypertension can reduce their blood pressure.
An open book icon represents the breadth of clinical evidence for the Symplicity procedure.

Real-world results

See data from the GLOBAL SYMPLICITY REGISTRY, the largest renal denervation data set.

An icon featuring a manual blood pressure cuff and pump.

Take action on hypertension

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

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Find education resources

Discover a wide range of educational content about the Symplicity blood pressure procedure, including CME courses and presentations.

*

In typical uncontrolled hypertension patients.

RDN arm reduction from baseline.

ANCOVA adjusted; secondary efficacy analysis.

1

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. The Lancet. 2018;391:2346–2355.

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. The Lancet 2020; Published online March 29, 2020. DOI: 10.1016/ S0140-6736(20)30554-7.

3

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. The Lancet. 2022; 399:1401-1410.