PROVIDING SAFE, CONTINUOUS BLOOD PRESSURE REDUCTION

LEARNING AND EVOLVING

The SPYRAL HTN Global Clinical Trial program, including the SPYRAL HTN-ON MED and SPYRAL HTN-OFF MED trials, is a multi-phase clinical strategy designed to isolate and demonstrate the efficacy and safety of the renal denervation procedure. 

Comprehensive Clinical Program1-5

Clinical Program Graphic

The trials focus specifically on the investigational Symplicity Spyral™ multi-electrode renal denervation catheter and the Symplicity G3™ renal denervation RF generator, designed to help reduce blood pressure in patients whose hypertension is not controlled despite medical therapy and lifestyle changes. SPYRAL HTN is a global study program, with patients randomized across sites in the United States, Europe, Japan, Australia, and Canada.

Dr. Kandzari presents the SPYRAL HTN-ON MED trial results.

RDN FINDINGS ARE PROMISING

Data from the ON MED and OFF MED trials is centered around blood pressure reduction and major safety events at the 6-month evaluation of the first 80 patients.  

“ALWAYS ON” 

  • SPYRAL HTN-OFF MED patients had statistically lower systolic blood pressure (BP) in the high-risk zone* at 3 months.1
  • SPYRAL HTN-ON MED patients showed lower 24-hour systolic blood pressure, including in the high-risk zone.2
  • MDT RDN has been used in more than 10,000 real world cases and its clinical evidence covers more than 11,000 years of patient follow-up.6

* High-risk zone occurs in the late night/early morning period and is usually associated with increased risk for stroke and cardiovascular events.7

 

On Med RDN Chart

A chart showing ON MED RDN and the high risk zone.

Chart On Med SHAM Control
EXCELLENT SAFETY PROFILE
  • No major adverse events through 6 months in the SPYRAL HTN-ON MED or SPYRAL HTN-OFF MED trials1,2
  • Procedural and long-term safety through 3 years in real clinical practice8
  • Does not affect kidney function9
PROVEN RESULTS

Proven effective in the presence and absence of drugs at six and three months, respectively.1,2

MORE TO COME

SPYRAL HTN-ON MED (ON MED EXTENSION)

The design of the sham-controlled SPYRAL HTN-ON MED Randomized Control Trial builds on the randomized sham-controlled SPYRAL HTN-ON MED pilot study. Similarly, it is expected to show RDN with the Symplicity™ renal denervation device can play an important role in managing blood pressure for patients prescribed antihypertensive medications. 

SPYRAL HTN-OFF MED PIVOTAL TRIAL

SPYRAL HTN Pivotal Trial investigates the blood-pressure-lowering effect and safety of renal denervation in the absence of medication. The primary efficacy and safety endpoints in the trial are 24-hour blood pressure at three months and incidence of major adverse events through one-month post-randomization.

Review the results when they are available: 

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1

Kandzari DE, et al. Lancet. 2018;391:2346–2355.

2

Townsend RR, et al. Lancet. 2017;390:2160–2170. 

3

Symplicity HTN-1 Investigators. Hypertension. 2011;57:911-917.

4

Symplicity HTN-2 Investigators. Lancet. 2010;376:1903-1909.

5

Bhatt DL, et al. N Engl J Med. 2014;370:1393–1401. 1.

6

Medtronic Data on File.

7

Kario K et al, ACC 2018

8

Global Symplicity Registry

9

Mahfoud F, et al. Presented at EuroPCR. 2018. Vascular complication rate was 0.9%, 1.0%, 1.1%, 0% at 6-mo, 1-yr, 2-yr, 3-yr, respectively.

All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. All other brands are trademarks of a Medtronic company.  For distribution only in markets where the Symplicity Spyral™ multi-electrode renal denervation catheter and Symplicity G3™ renal denervation RF generator have been approved. Not for distribution in the USA, Japan or France.