The Symplicity Spyral™ renal denervation system, which is used during the Symplicity™ procedure, 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 and sign up for email to receive the latest resources.
The Symplicity Spyral™ system is proven to deliver significant, safe, and sustained blood pressure reductions.1–5
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 6 months.2
(N = 253)
Sustained
17 mmHg
mean reduction in office SBP real-world patients at three years with the Symplicity™ renal denervation catheter.†,4
(N = 1,337)
Results may vary.
Individual trial designs vary.
Results may vary.
In the presence of medications
In the absence of medications
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 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™ system in uncontrolled hypertension patients on no antihypertensive medications (n = 331).
Results may vary.
Office SBP
24-hr SBP
Average baseline office systolic blood pressure (SBP) for both RDN and sham arms in both trials = 163 mmHg
Spyral HTN OFF-MED Chart
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 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™ system in uncontrolled hypertension patients on one to three antihypertensive medications (n = 337).
Results may vary.
Office SBP
24-hr SBP
Average baseline office systolic blood pressure (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.
Global SYMPLICITY Registry (GSR-DEFINE)3,4
Enrolled over 3,300 patients‡:
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.3,4
Symplicity Spyral™ RDN system
Baseline BP 164 ± 25 mmHg
18 mmHg mean reduction in office SBP at three years in patients treated with the Symplicity Spyral™ catheter.6
p < 0.001 at all timepoints versus baseline PB.
Results may vary.
Now enrolling the post-approval study at sites across the United States.
Learn more about the turning point in hypertension care and how it can help enhance treatment strategies.
Learn about Symplicity Spyral™ RDN system’s components and their role in the Symplicity™ blood pressure procedure.
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† Includes Symplicity Spyral™ and Flex RDN catheters.
‡ Study follow-up is ongoing. Data does not represent follow-up for all patients.
