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of hypertension patients in the U.S. do not have their blood pressure under control.2
of hypertension patients become non-adherent to their medication within one year.3
of all U.S. healthcare spending in 2016 was for adults with hypertension.4
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.
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.
The SPYRAL HTN-ON MED Randomized Control Trial 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.
The Symplicity Blood Pressure Procedure 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.
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ANCOVA adjusted; secondary efficacy analysis.
RDN arm reduction from baseline.
National Center for Health Statistics, Centers for Disease Control and Prevention. National Health and Nutrition Examination Survey (NHANES), 2015–2018.
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.
Jung O, Gechter JL, Wunder C, et al. Resistant hypertension? Assessment of adherence by toxicological urine analysis. Hypertension. April 2013;31(4):766–774.
HCCI research. 2018 Schmieder et al, data presented at EuroPCR 2016.