Clinical Evidence Overview

Clinical research showed that renal denervation with the Symplicity™ renal denervation system may provide safe reductions in blood pressure levels for patients with uncontrolled blood pressure despite multiple antihypertensive medications.

This research includes:

  • Symplicity HTN-1: series of pilot studies (n=153)
  • Symplicity HTN-2: randomized controlled study (n=106)
  • SYMPLICITY HTN-3: US randomized controlled study (n=535)
  • Global SYMPLICITY Registry*: open label, multi-indication registry (n≈5000)
  • Symplicity Spyral Feasibility Study (n=50)

Medtronic also actively collaborates with physician partners in the ongoing evaluation of this groundbreaking therapy. Data is being generated evaluating the Symplicity renal denervation system for use in patients with hypertension, insulin resistance, heart failure, and other conditions related to sympathetic excess.

Symplicity HTN-1 and HTN-2 Clinical Trials

SAFE PROCEDURE
The Symplicity renal denervation system has an exceptional safety record. In both the Symplicity HTN-1 and HTN-2 clinical trials, there have been:

  • No serious adverse events related to delivering RF to the renal artery with the Symplicity Flex™ catheter
  • No evidence of vascular injury/stenosis at a treatment site via imaging at 6 months
  • No orthostatic or electrolyte disturbances
  • Sustained renal function (eGFR and creatinine)

SUPERIOR REDUCTIONS IN BP VERSUS MEDICAL MANAGEMENT
The Symplicity renal denervation system was proven to be superior to medical management in the Symplicity HTN-2 clinical trial. Symplicity HTN-2 was a randomised, controlled clinical trial of 106 patients. Patients randomised to RDN therapy plus antihypertensive medications achieved a significant reduction in mean blood pressure (-32/-12 mmHg) at 6 months, whereas patients in the control group randomised to receive antihypertensive medications alone had blood pressures that did not vary from baseline (+1/0 mmHg).

Symplicity HTN-2 Randomised Controlled Trial

SUSTAINED REDUCTIONS IN BP THROUGH 3 YEARS
Symplicity HTN-1 was a series of pilot studies involving 153 patients. Patients who have reached 3 year follow-up in the Symplicity HTN-1 study have shown a sustained reduction in blood pressure.

3-year Post RDN Results3

Symplicity HTN-1

Global SYMPLICITY Registry

REMARKABLE SAFETY PERFORMANCE AND IMPRESSIVE BLOOD PRESSURE REDUCTIONS ACHIEVED IN THE GLOBAL SYMPLICITY REGISTRY (GSR)3
The Global SYMPLICITY registry, which incorporates the GREAT SYMPLICITY registry initiated in Germany, is being conducted worldwide to evaluate the safety and efficacy of treatment with the Symplicity renal denervation system in real world uncontrolled hypertensive patients.

Early results demonstrate renal denervation with the Symplicity RDN system to be both a safe procedure and effective at reducing blood pressure.

RDN GSR Data


SYMPLICITY HTN-3 Trial

SYMPLICITY HTN-3 6 Month Results
SYMPLICITY HTN-3 was the first randomized sham controlled trial in renal denervation. The study did not meet its primary efficacy endpoint but met its primary safety endpoint.
Bhatt DL et al. N Engl J Med. 2014 Apr 10;370(15):1393-401

Impact of Renal Denervation on 24-Hour Ambulatory Blood Pressure
Bakris GL et al. J Am Coll Cardiol. 2014 Sep 16;64(11):1071-8

Predictors of blood pressure response in the SYMPLICITY HTN-3 trial
Kandzari DE et al. Eur Heart J. 2015 Jan 21;36(4):219-27


Primary Efficacy Endpoint Office Systolic Blood Pressure at 6 Months, 5 mm Superiority Margin

RDN HTN-3 Results


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References

  1. Symplicity HTN-1 Investigators; Krum H, Barman N, Schlaich M, et al. Hypertension. 2011;57:911-917. Expanded results presented at the Transcatheter Cardiovascular Therapies annual meeting 2013.
  2. Symplicity HTN-2 Investigators; Esler MD, Krum H, Sobotka PA, et al. Lancet. 2010;376:1903-1909.
  3. Expanded results presented at the Transcatheter Cardiovascular Therapies annual meeting 2013.