Renal denervation for hypertension

Clinical data

The SPYRAL HTN Global Clinical Program focuses on the Symplicity™ blood pressure procedure, which is proven to reduce blood pressure in patients with hypertension (HTN).1,2

  

  

> 25,000

patients treated globally with the Symplicity™ RDN system3

Setting the standard in renal denervation

The SPYRAL HTN Clinical Program features the most rigorous and extensive patient experience as shown in multiple clinical trials and the largest real-world patient registry.1,2,4–9

Significant, safe, and sustained blood pressure reductions

The Symplicity™ blood pressure procedure has demonstrated significant, safe, and sustained blood pressure reductions in randomized controlled trials.1,2,7–9

> 9

mmHg

mean reduction in OSBP in patients off and on medications1,7

18

mmHg

mean reduction in OSBP real-world patients at three years with the Symplicity Spyral™ catheter,
n = 26710

Largest real-world registry

The Global SYMPLICITY Registry, which includes a cross-section of high-risk patient subgroups, has shown blood pressure reductions between -10 and -20 mmHg out to three years.9

Unmatched clinical evidence

The Symplicity™ blood pressure procedure is supported by published clinical evidence unmatched in scope, quantity, and quality.

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.

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. 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.

3. Medtronic data on file. RDN catheter historical data, June 2023. Data includes both Symplicity™ Flex and Symplicity Spyral™.

4. 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. Lancet. 2018;391(10137):2346–2355. doi: 10.1016/S0140-6736(18)30951-6.

5. Townsend RR, Mahfoud F, Kandzari DE, et al. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet. 2018;390(10108):2160–2170. doi: 10.1016/S0140-6736(17)32281-X.

6. 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.

7. Kandzari DE, Townsend RR, 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.

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

9. 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.

10. Medtronic data on file. Global SYMPLICITY Registry clinical data snap, March 2023.

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