EXPLORE SYMPLICITY SPYRAL™

The SPYRAL HTN Clinical Program is
studying renal denervation with the
Medtronic Symplicity Spyral™ Renal
Denervation System in patients with
uncontrolled hypertension.


CAUTION: Investigational device.
Limited by U.S. law to investigational use.

HYpertension Affects 50% of U.S. Adults1

Hypertension remains a critical challenge in the United States, where rates of control continue to decline, despite widespread prescription of lifestyle modifications and medication. Consider these facts:
75% of hypertension patients in the U.S. do not have their blood pressure under control.
50% of hypertension patients become non-adherent to their medication within one year.
41% of all U.S. healthcare spending in 2016 was for adults with hypertension.

About The Clinical Program

The SPYRAL HTN Clinical Program is evaluating the Symplicity Spyral™, an investigational device, for hypertension.

The program purpose is to provide information about the safety and effectiveness of an investigational procedure to help reduce blood pressure in patients whose blood pressure is uncontrolled.

Medtronic is committed to addressing unmet hypertension needs. More than 4,000 patients have been studied across multiple trials.

Recent results from the spyral htn-off med and on med trials

The SPYRAL HTN Global Clinical Trial program, including the SPYRAL HTN-OFF MED Pivotal trial and SPYRAL HTN-ON MED pilot study, is a multi-phase clinical strategy designed to isolate and demonstrate the safety and efficacy of the RDN procedure for patients with uncontrolled hypertension.

SPYRAL htn-off med pivotal trial

The SPYRAL OFF MED trial showed a drop of 9.2 mmHg in office systolic blood pressure at 3 months.

The SPYRAL HTN-OFF MED Pivotal trial evaluated the safety and efficacy of renal denervation in patients with uncontrolled hypertension in the absence of anti-hypertensive medication.

spyral htn-on med pilot study

The SPYRAL ON MED study showed a drop of 9.4 mmHg in office systolic blood pressure at 6 months.

The SPYRAL HTN-ON MED pilot study evaluated the safety and efficacy of renal denervation in patients with uncontrolled hypertension in the presence of anti-hypertensive medication.

CAUTION: Investigational device. Limited by U.S. law to investigational use.

About The
Procedure

The Medtronic Symplicity Spyral™ Renal Denervation System supplies radiofrequency (RF) energy to the renal nerves to disrupt the sympathetic signal between the brain and the kidney. Regulating these nerves may help the kidneys better manage blood pressure.

The Symplicity Spyral RDN catheter ablating the renal nerves during a procedure.
A physician speaking with a pair of patients.

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ANCOVA adjusted; secondary efficacy analysis.

RDN arm reduction from baseline.

1

National Center for Health Statistics, Centers for Disease Control and Prevention. National Health and Nutrition Examination Survey (NHANES), 2015-2018.

2

U.S. Department of Health and Human Services. The Surgeon General’s Call to Action to Control Hypertension. Washington, DC: U.S. Department of Health and Human Services, Office of the Surgeon General; 2020.

3

Jung O, Gechter JL, Wunder C, et al. Resistant hypertension? Assessment of adherence by toxicological urine analysis. Hypertension. April 2013;31(4):766-774.

4

HCCI research. 2018 Schmieder et al, data presented at EuroPCR 2016.

5

Böhm M et al. The Lancet 2020; Published online March 29, 2020.

6

Kandzari DE et al. The Lancet. 2018 Jun 9;391(10137):2346-2355.

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