SYMPLICITY SPYRAL™ RENAL DENERVATION (RDN) SYSTEM
Clinical evidence
The Symplicity Spyral RDN system is backed by multiple sham-controlled trials and the largest real-world registry. The SPYRAL HTN clinical program is the largest renal denervation clinical program, studying more than 4,000 patients worldwide.*†1–3 Read on to understand our extensive clinical evidence.
Significant, safe, and sustained blood pressure reductions
The Symplicity™ blood pressure procedure uses the Symplicity Spyral RDN system, which is proven to deliver significant, safe, and sustained blood pressure reductions.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 no new incidence of renal artery stenosis (> 70%) at 1 month.2
(N = 253)
Sustained
18
mmHg
mean reduction in office SBP real-world patients at three years with the Spyral catheter, n = 267‡5
‡Results may very across patients.
Reduced blood pressure in the presence and absence of medication
Multiple randomized, sham-controlled trials show blood pressure reductions in the presence and absence of medication following use of the Symplicity Spyral RDN system.1,2
Individual trial designs vary.
Results may vary.
Read on to learn more about the SPYRAL HTN clinical trial program, including:
Significant blood pressure reductions in the absence of medication at 3 months
| Patient baseline characteristics |
RDN |
Sham |
|---|---|---|
| Age (years) |
52 |
53 |
| Sex (male) |
64% |
68% |
| Black Americans (% of study) |
22% |
19% |
| Office SBP (mmHg) |
162.7 ± 7.8 |
162.9 ± 7.5 |
| 24-hr SBP (mmHg) |
151.4 ± 8.1 |
151.0 ± 7.5 |
Pivotal, randomized, sham-controlled trial to show safety and efficacy of the Symplicity Spyral RDN system in uncontrolled hypertension patients on no antihypertensive medications
(n = 331).
Results may vary.
- Blood pressure reductions following Symplicity Spyral RDN system were present throughout the day and night.
- 24-hour ABPM primary endpoint not met due to a biased increase in medications in the sham control arm.
Significant blood pressure reductions with 20% lower medication burden at 6 months with RDN (2.9 RDN vs. 3.5 sham, p = 0.04)
| Patient baseline characteristics |
RDN |
Sham |
|---|---|---|
| Age (years) |
55 |
55 |
| Sex (male) |
81% |
79% |
| Black Americans (% of study) |
17.0% |
19.1% |
| Office SBP (mmHg) |
163.0 ± 7.7 |
163.1 ± 7.9 |
| 24-hr SBP (mmHg) |
149.6 ± 7.0 |
149.3 ± 7.0 |
Randomized, sham-controlled trial to show long-term efficacy and safety of the Symplicity Spyral RDN system in uncontrolled hypertension patients on one to three antihypertensive medications (n = 337).
Results may vary.
Blood pressure reductions following Symplicity Spyral RDN system were present throughout the day and night.
Enrolled over 3,000 patients†:
- With uncontrolled hypertension on an average of 4.6 medications.
- With consistent mean number of medications throughout the follow-up period.
- Treated with the Symplicity Spyral and Flex™ RDN catheters in real-world experience.
Real-world results3,5
Symplicity RF system
Baseline BP 165 ± 25 mmHg
Symplicity Spyral and Flex renal denervation catheters safely reduced blood pressure through 36 months, independent of the number and type of baseline antihypertensive medication classes.3,6
Symplicity Spyral RDN system
Baseline BP 164 ± 25 mmHg
18 mmHg mean reduction in office SBP at three years with the Symplicity Spyral catheter.‡5
p < 0.001 at all timepoints versus baseline PB.
Results may vary.
Our body of evidence continues to grow
SPYRAL AFFIRM Global Study
Now enrolling the post-approval study at sites across the Unites States.
Read the manuscripts.
View product details.
Learn about Symplicity Spyral RDN system’s components and their role in the Symplicity blood pressure procedure.
See how renal denervation can help.
Learn more about the turning point in hypertension care and how it can help enhance management strategies.
Contact us
Our goal is to support you and your practice as you become familiar with this emerging therapy.
*
Includes Symplicity Spyral and Flex RDN catheters.
†
Study follow-up is ongoing. Data does not represent follow-up for all patients.
‡
Results may vary across patients.
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 et al. Outcomes following radiofrequency renal denervation according to antihypertensive medications: subgroup analysis of the Global SYMPLICITY Registry DEFINE. EuroPCR 2023.
4
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. April 9, 2022;399(10234):1401–1410.
5
Medtronic data on file. Global Symplicity Registry clinical data snap, March 2023.
6
Mahfoud F, Mancia G, Schmieder RE, et al. Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE. Hypertension. August 2023;80(8):1759–1770.
- Symplicity Spyral RDN System, Licensed as , SYMPLICITY SPYRAL MULTI ELECTRODE RENAL DENERVATION SYSTEM