Clinical Data

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Clinically meaningful blood pressure reduction across 7,000 patients*2,3

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.1,4-7

Data from randomized controlled trials

The Symplicity blood pressure procedure has demonstrated signifcant, safe and sustained blood pressure reductions in randomized controlled trials.1,4-6

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.7

Unmatched clinical evidence

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

Patients enrolled in Medtronic-sponsored, funded or physician-initiated studies.

In typical uncontrolled hypertension patients.

ANCOVA adjusted; secondary efficacy analysis.

§

RDN arm reduction from baseline.

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Death, stroke, end-stage renal disease, or MI.

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

2

Lewington S. Age-specifc relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. The Lancet. 2002;360(9349):1903-1913.

3

Data on file, Medtronic. April 2021.

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

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.

6

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. The Lancet. 2017;390(10108):2160–2170.

7

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.

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