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
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
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
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.
Transforming hypertension treatment
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 data set.
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, 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.