The most extensive body of clinical evidence for RDN
The SPYRAL HTN Global Clinical Program focuses on the Symplicity blood pressure procedure, which is designed to reduce blood pressure in patients with hypertension.
SPYRAL HTN-ON MED Trial
This RCT is evaluating the safety and efficacy of renal denervation to reduce blood pressure when used in the presence of up to three standard anti-hypertensive medications. Primary endpoints:
- Acute and chronic safety by evaluating incidence of major adverse events
- Change in systolic blood pressure as measured by 24- hour ambulatory blood pressure monitoring (ABPM)
SPYRAL AFFIRM
This study will evaluate the long-term safety, efficacy, and durability of the Symplicity blood pressure procedure.
- 1,000 patients
- 100 global trial sites
- Three high-risk subgroups
- Three-year follow-up
- Five-year follow-up in 200 patients in ON & OFF MED trials
Presence of medications
SPYRAL HTN-ON MED Pilot Study
This pilot study demonstrated reductions in office systolic blood pressure at three years in patients receiving the Symplicity blood pressure procedure in the presence of anti- hypertensive medications.
- -18.7 mmHg 24-hour systolic BP at three years4
- -20.9 mmHg office SBP at three years4
- >80% of patients taking meds achieved SBP <140 mmHg with the Symplicity procedure4
- Zero device or procedural safety events through three years4
Absence of medications
SPYRAL HTN-OFF MED Pivotal Trial
This study demonstrated that the Symplicity blood pressure procedure decreases blood pressure and is safe when studied in the absence of anti-hypertensive medications.
- -9.2 mmHg office SBP at three months2
- 0 device- or procedure-related MAEs through three months2
GLOBAL SYMPLICITY REGISTRY
The largest renal denervation (RDN) data set in the world, the GLOBAL SYMPLICITY REGISTRY has demonstrated the safety and efficacy of the Symplicity blood pressure procedure in a variety of patients representative of daily clinical practice, making it a vital source of insights for patient selection.5
- -16.7 mmHg reduction in office SBP at 3 years5
- Zero device- or procedure-related major adverse events at 3 years5
GSR DEFINE
This is a prospective, multi-center, single-arm, non-interventional and open-label registry that will document the long-term safety and effectiveness of the Symplicity blood pressure procedure in a real-world patient population with hypertension. GSR DEFINE is the continuation of the GLOBAL SYMPLICITY REGISTRY.
- 5,000 total patients§
- 300+ sites worldwide
- One to fve years of follow-up
Patient preference study
Global Patient Preference
An article published in the Journal of Hypertension shows that patients with hypertension may see RDN, including the Symplicity blood pressure procedure, differently than physicians. It explains why many of these patients, including those who are not currently taking anti-hypertensive medications, may prefer the procedure as a way to reduce their blood pressure.
Find education resources
Explore CME courses and presentations about the Symplicity blood pressure procedure.
See how the procedure works
Learn more about the Symplicity blood pressure procedure.
Take action on hypertension
Gain access to resources to introduce the Symplicity blood pressure procedure to your community successfully.
*
Includes Symplicity Spyral™ and Flex™ catheters.
†
Death, stroke, end-stage renal disease, or MI.
‡
Compared to modeled control group in the GLOBAL SYMPLICITY REGISTRY.
§
2,000 patients incremental to the GLOBAL SYMPLICITY REGISTRY.
1
Medtronic Data on File.
2
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 Jun 9;391(10137):2346-2355.
3
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.
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. The Lancet. 2022; 399:1401-1410.
5
Mahfoud F, Mancia G, Schmieder R, et al. Three-year safety and efficacy in the Global Symplicity Registry: Impact of antihypertensive medication burden on blood pressure reduction. Presented at PCR e-course 2020.
6
Schmieder R, Böhm M, Schlaich M, et al. Modeled Clinical Event Reductions at Three Years in High-Risk Hypertension Patients Treated with Renal Denervation. Presented at Deutsche Gesellschaft fur Kardiologie 2021.
7
Schmieder, R.E., Högerl, K., Jung, S. et al. Patient preference for therapies in hypertension: a cross-sectional survey of German patients. Clinical Research in Cardiology 108, 1331–1342 (2019).