#Ireland #Medtronic #Galway #Symplicity #SPYRAL HTN

Significant Blood Pressure Reductions Observed in Long-Term SPYRAL HTN-ON MED Results

Overview
A new milestone in hypertension treatment has been achieved as Medtronic plc, a pioneer in healthcare technology, released long-term findings from its SPYRAL HTN-ON MED clinical trial. Conducted over three years, the trial has provided strong evidence of sustained blood pressure reductions in patients undergoing the Symplicity™ renal denervation (RDN) procedure. This breakthrough has been spotlighted at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference.

Study Insights
The SPYRAL HTN-ON MED trial was a rigorous, randomized, sham-controlled study that extensively evaluated the blood pressure-lowering impact of the Symplicity RDN system in patients with hypertension actively on multiple anti-hypertensive medications. The trial's end results demonstrated that participants who received RDN exhibited a clinically significant reduction in both ambulatory and office-based blood pressure readings when compared to sham treatment groups.

Data exhibited by Medtronic indicated that patients in the RDN group (N=206) achieved an impressive -14.0 mmHg reduction in 24-hour ambulatory systolic blood pressure (ABPM), in contrast to -9.3 mmHg for the sham group (treatment difference -4.7 mmHg; p=0.0028). Office-based systolic blood pressure (OSBP) results also corroborated these findings, with the RDN group recording a reduction of -18.5 mmHg compared to -11.7 mmHg in the sham group (treatment difference -7.4 mmHg; p=0.0002).

Safety and Side Effects Observed
An important highlight from these findings is the long-term safety profile of the Symplicity system, where no renal artery stenosis exceeding 70% was encountered among those treated with RDN throughout the study period. This reinforces the system's safety and its enduring efficacy in managing hypertension effectively.

Expert Opinions
Dr. David Kandzari, chief of the Piedmont Heart Institute and a co-principal investigator of the SPYRAL clinical program, expressed optimism regarding the findings, commenting, "Radiofrequency renal denervation with the Symplicity blood pressure procedure continues to demonstrate a durable and clinically meaningful blood pressure-lowering effect." He noted the continued decrease in blood pressure levels even among patients initially treated as controls, signifying the widespread applicability of this procedure.

Moreover, Medtronic’s Senior Vice President Jason Weidman stated, "These results further underscore the consistent and durable effects of the Symplicity blood pressure procedure, with the most long-term data presented and published to date." With findings from over 5,000 patients studied and more than 30,000 procedures performed globally, the Symplicity blood pressure procedure has cemented its status as a standard-bearer in renal denervation technology.

Conclusion
The long-term data emerging from the SPYRAL HTN-ON MED trial signifies a remarkable advancement in the treatment landscape for resistant hypertension. For patients who remain uncontrolled despite medications and lifestyle adjustments, the Symplicity RDN procedure presents a compelling interventional option for achieving better blood pressure control. Medtronic continues to lead the way with innovative solutions aimed at improving patient outcomes, alleviating pain, restoring health, and extending lives around the globe.