TCT 2025: Medtronic's Symplicity Spyral RDN Demonstrates Sustained Blood Pressure Reduction of 18.5 mmHg at Three Years, Significantly Outperforming Sham Control

Medtronic Presents Latest Long-term Results from the Final Report of the SPYRAL HTN-ON MED Randomized Clinical Trial at TCT2025: Three-Year Follow-Up Shows Significant Blood Pressure Reduction in Patients Treated with Symplicity Spyral Compared to Sham Control.

SPYRAL HTN-ON MED is a global, multi-center, randomized, sham-controlled clinical trial designed to evaluate the blood pressure-lowering efficacy and safety of the Symplicity RDN system, based on radiofrequency technology, in hypertensive patients taking no more than three antihypertensive medications. After completing the six-month primary endpoint assessment, the study continued to evaluate changes in 24-hour ambulatory systolic blood pressure and office systolic blood pressure relative to baseline through annual follow-ups.

Specific Research Data

• With a similar medication burden, the RDN treatment group (206 cases) showed significant advantages over the sham procedure group (131 cases) during the three-year follow-up period:

• 24-hour dynamic systolic blood pressure (ABPM): RDN group decreased by 14.0 mmHg, sham group decreased by 9.3 mmHg (between-group difference: -4.7 mmHg; p=0.0028)

• Office Systolic Blood Pressure (OSBP): RDN group decreased by 18.5 mmHg, sham group decreased by 11.7 mmHg (between-group difference: -7.4 mmHg; p=0.0002)

• Safety Performance
  

During the three-year follow-up period, no renal artery stenosis greater than 70% (i.e., narrowing of the renal blood supply artery diameter) was observed in the RDN group, confirming the long-term safety of the Symplicity Spyral RDN system.

PI Evaluation

"Symplicity Renal Denervation Continues to Demonstrate Sustained and Clinically Significant Blood Pressure Reduction. Three-year follow-up data show that patients treated with the Symplicity Spyral RDN System (including the initial treatment group and approximately three-quarters of the control group who subsequently received Symplicity treatment) experienced continued blood pressure reduction."

---David Kandzari   Piedmont Heart Institute

Executive Evaluation

"These results further confirm the sustained and stable efficacy of the Symplicity hypertension therapy, representing the longest follow-up data published to date. So far, more than 5,000 patients globally have participated in clinical studies, with over 30,000 procedures completed. For patients whose blood pressure remains poorly controlled despite medication and lifestyle interventions, and who are seeking interventional therapies, the Symplicity hypertension therapy continues to set the gold standard in renal denervation due to its safety, efficacy, and durability."

---Jason Weidman  Senior Vice President and President of Medtronic Cardiovascular Business Segment, Coronary and Renal Denervation

Spyral

SpyralIt is a catheter-based radiofrequency ablation device that delivers radiofrequency energy through an ablation catheter.Overactive nerves in the renal arteryThe procedure, radiofrequency ablation, will help patients with hypertension lower their blood pressure and reduce reliance on antihypertensive medications.

SpyralComposed of a multi-electrode ablation catheter (SYMPLICITY SPYRAL) and a radiofrequency generator (SYMPLICITY G3).

• Symplicity Spyral Catheter

• SYMPLICITY G3

Medtronic