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 reductions1–4
The Symplicity Spyral™ radiofrequency renal denervation (rfRDN) system is backed by the SPYRAL HTN Clinical program — the largest renal denervation clinical program studying more than 5,000 patients in multiple sham-controlled trials, and the largest real-world renal denervation registry.†,1–3,5–8
18.5 mmHg
mean reduction in office systolic blood pressure (SBP) at 3 years in patients taking medication.4
(N = 175)
< 0.4%
major adverse events at composite endpoint, including no new incidence of renal artery stenosis (> 70%) at 6 months.2
(N = 253)
> 5,000
patients studied in the SPYRAL HTN Clinical program.†,‡,1–3,5–8
Adverse events include, but are not limited to, pain and hematoma. Results may vary.
Durable results, amplified over time
Patients who underwent the Symplicity™ procedure continued to see additional blood pressure reductions through three years, demonstrating durable results that amplify over time following rfRDN.4 Most patients continue taking their medication after the procedure. Results may vary.
OFF MED
Scientific evidence of efficacy without meds
ON MED
Prospective evidence in the presence of meds
GSR†,3
Large dataset of multiple subgroups in real-world setting
Read on to learn more about the SPYRAL HTN clinical program, including:
SPYRAL HTN-OFF MED Trial1
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).
Significant blood pressure reductions in the absence of medication at three months
Results may vary.
Office SBP
Average baseline = 163 mmHg
24-hr SBP
Average baseline = 151 mmHg
Blood pressure reductions following Symplicity Spyral™ system were present throughout the day and night.
SPYRAL HTN-ON MED Trial2
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).
Durable blood pressure reductions in the presence of medication out to three years.4
At three years, 74% of patients treated in the sham arm elected to undergo the Symplicity™ procedure.
Results may vary.
Office SBP
Average baseline =
163 mmHg
24-hr SBP
Average baseline =
150 mmHg
Average baseline =
149 mmHg
Blood pressure reductions following Symplicity Spyral™ system were present throughout the day and night.
P-values are ANCOVA adjusted for baseline BP.
GSR-DEFINE3
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™ rfRDN system3
Baseline BP 164 ± 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
The change in AH medications to 36 months was –0.15 ± –1.34 (p < 0.0001; n = 1,984).
Results may vary.
GSR-DEFINE showed stable kidney function in real-world patients at three-year follow up.10
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 in all geographies. The generator and catheter used in the SPYRAL GEMINI 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.
SPYRAL CARE Study
This study is evaluating long-term effectiveness of the Symplicity™ procedure for lowering blood pressure in Medicare patients with uncontrolled hypertension.
View our reimbursement webpage to access Medicare information and resources.
Visit Medtronic Academy.
Browse hypertension and renal denervation education, including interactive learning modules, various webinars, downloads, and more.
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.
Stay connected.
Sign up for email so we can send relevant information and resources directly to your inbox.
