SYMPLICITY SPYRAL™ RENAL DENERVATION (RDN) SYSTEM
This is the turning point in hypertension care
Lifestyle changes and medications have defined hypertension care — until now. See how the Symplicity Spyral RDN system complements existing hypertension treatment protocols, review clinical evidence, and sign up to receive resources directly through email.
Introducing the Symplicity Spyral RDN system
Current hypertension care strategies are not always enough to help patients achieve blood pressure control. The Symplicity Spyral RDN system is used during the Symplicity™ blood pressure procedure — the first catheter-based approach using radiofrequency (RF) energy that complements medications and lifestyle modifications to help reduce blood pressure.
Watch a short video to see why we’ve spent the last 10 years dedicated to developing an alternative solution to manage this disease.
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The Symplicity Spyral RDN system is proven to achieve significant, safe, and sustained blood pressure reductions in the presence and absence of medications in multiple clinical trials and a real-world patient registry.1–4
Significant
> 9
mmHg
mean reduction in office systolic blood pressure (SBP) in patients on and off medications at primary endpoint follow-up in multiple clinical trials*1,2
Safe
< 0.4%
major adverse events at composite endpoint including zero incidents of renal artery stenosis2
Sustained
18
mmHg
mean reduction in office SBP real-world patients at three years with the Spyral catheter, n = 267*5
*Results may vary across patients.
The Symplicity Spyral RDN system is comprised of the Symplicity Spyral multi-electrode renal denervation catheter and the Symplicity G3™ renal denervation RF generator.
Patients whose blood pressure is difficult to control may have an overactive sympathetic nervous system. The Symplicity procedure aims to suppress this inappropriately elevated sympathetic drive. The Symplicity Spyral system offers a versatile, simple, and minimally invasive method to perform renal denervation.6
The procedure is performed by interventionalists due to its similarity to other procedures they perform every day.
Understanding which patients could benefit from the Symplicity procedure is an important step when considering this therapy.
Your patients may benefit if they:
Have uncontrolled
hypertension
Consider patients where lifestyle modifications and antihypertensive medications haven’t adequately controlled blood pressure.
Are willing to undergo
an interventional procedure
Consider patients who opt for the Symplicity procedure following shared decision-making and an attempt at lifestyle modifications and medical therapy.
Recommended by cardiovascular experts
The 2023 SCAI position statement recognizes renal denervation as a promising therapy for treating hypertension. Read the full statement to review recommendations for success, including patient selection, operator competency, procedural training and techniques, and organizational recommendations.
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Learn about Symplicity Spyral RDN system’s components and their role in the Symplicity blood pressure procedure.
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References
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.
2
Kandzari D, Townsend R, Kario K, et al. Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications. J Am Coll Cardiol. November 7, 2023;82(19):1809–1823.
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. Lancet. 2022;399(10234):1401–1410.
4
Mahfoud F, et al. Outcomes following radiofrequency renal denervation according to antihypertensive medications: subgroup analysis of the Global SYMPLICITY Registry DEFINE. EuroPCR 2023.
5
Medtronic data on file. Global Symplicity Registry clinical data snap, March 2023.
6
Medtronic Symplicity Spyral multi-electrode renal denervation catheter Instructions for Use.