Symplicity™ blood pressure procedure
Clinical evidence
The Symplicity Spyral™ renal denervation (RDN) system, used during the Symplicity™ procedure, is backed by extensive clinical evidence.
Significant, safe, and sustained blood pressure reductions
The SPYRAL HTN clinical program studied the safety and effectiveness of the Symplicity Spyral™ system. It is the largest renal denervation clinical program, studying more than 5,000 patients worldwide in multiple sham-controlled trials, and has the largest real-world registry.†,‡,1–3 The program proved that the Symplicity Spyral™ system delivers 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 trials1,2
Safe
< 0.4%
major adverse events at composite endpoint, including no new incidence of renal artery stenosis (> 70%) at six months2
(N = 253)
Sustained
17 mmHg
mean reduction in office SBP at 3 years with the Symplicity Spyral™ catheter†,§,5
(N = 1,539)
Results may vary.
Durable results, amplified over time
Patients who underwent the Symplicity™ procedure continued to see additional blood pressure reductions from six months to two years, demonstrating durable results that amplify over time.6 Results may vary.
Read on to learn more about the SPYRAL HTN clinical program, including:
SPYRAL HTN-OFF MED Trial1
Significant blood pressure reductions in the absence of medication at three 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™ system in uncontrolled hypertension patients on no antihypertensive medications (n = 331).
Results may vary.
Office SBP
24-hr SBP
Average baseline office SBP for both RDN and sham arms in both trials = 163 mmHg
Blood pressure reductions following Symplicity Spyral™ system were present throughout the day and night.
SPYRAL HTN-ON MED Trial2
Significant blood pressure reductions with 20% lower medication burden at six 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™ system in uncontrolled hypertension patients on one to three antihypertensive medications (n = 337).
Results may vary.
Significant blood pressure reductions at two years6
P-values are ANCOVA adjusted for baseline blood pressure (BP).
Sixty-six patients crossed over from sham to RDN group.
Office SBP
Baseline BP (mmHg)
24-hour SBP
Baseline BP (mmHg)
Blood pressure reductions following Symplicity Spyral™ system were present throughout the day and night.
Global SYMPLICITY Registry (GSR-DEFINE)3
Enrolled over 3,900 patients‡:
- With uncontrolled hypertension on an average of 4.6 medications
- With consistent mean number of medications throughout the follow-up period
- Treated with either the Symplicity Spyral™ or the Flex RDN catheter in real-world experience
Real-world results for the Symplicity™ radiofrequency (RF) system3,6
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
p < 0.001 at all timepoints versus baseline BP.
Results may vary.
The Global SYMPLICITY Registry study showed stable kidney function at three-year follow up.7
Stable kidney function in real-world patients
Our body of evidence continues to grow.
SPYRAL GEMINI Pilot Study
This pilot study is investigating the safety and efficacy of multi-organ denervation in patients with uncontrolled hypertension, including those with or without high cardiovascular risk.
CAUTION: Hepatic denervation is limited by law to clinical investigation worldwide. The generator and catheter used in the SPYRAL GEMINI Pilot Study for hepatic denervation are not approved for sale or use in the United States or any other country.
SPYRAL AFFIRM Global Study
Enrollment is complete for this post-approval study. Study follow-up is ongoing.
Read the manuscripts.
View patient selection criteria.
Learn how to identify the appropriate patients for the Symplicity™ procedure.
View product details.
Learn about Symplicity Spyral™ RDN system’s components and their role in the Symplicity™ blood pressure procedure.
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